[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-hodgkins-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-hodgkins-lymphoma":63},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,49,76,100,129,158,193,227,254,290,319,343,365,386,420,443,460,495,520,558,581,601,620,640,667],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100362726","phase-2-acalabrutinib-with-da-epoch-r-or-r-chop-for-people-with-untreated-diffuse-large-b-cell-lymphoma-100362726",false,"NCT04002947","Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma","A Phase 2 Study of Acalabrutinib With DA-EPOCH-R or R-CHOP for Patients With Untreated Diffuse Large B-cell Lymphoma","-INCLUSION CRITERIA:\n\n1. Patients must have a confirmed histologic diagnosis of an aggressive B-cell lymphoma with morphologic appearance of DLBCL or high-grade B-cell lymphoma (HGBL) confirmed by the Laboratory of Pathology, NCI, with no prior treatment for DLBCL or HGBL. The following subtypes are included:\n\n   * DLBCL, NOS, Activated B-cell type (ABC)\n   * DLBCL, NOS, Germinal center B-cell type (GCB)\n   * T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n   * Primary cutaneous DLBCL, leg-type\n   * EBV+ DLBCL, NOS\n   * DLBCL associated with chronic inflammation\n   * ALK+ large B-cell lymphoma\n   * High-grade B-cell lymphoma, NOS\n   * High-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements\n\n   NOTE: Presence of concomitant indolent lymphomas such as follicular lymphoma, marginal zone lymphomas, monoclonal B-cell lymphocytosis or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma that are best categorized as composite or transformed lymphomas are allowed.\n2. A formalin-fixed tissue block or 15 slide of tumor sample (archival or fresh) must be available for performance of correlative studies.\n\n   NOTE: Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator. Patients must be willing to have a tumor biopsy if adequate archival tissue is not available (i.e., post-enrollment and prior to treatment).\n3. Measurable lymph nodes or masses of at least 1.5 centimeters (cm) on baseline CT or MRI\n4. Stage II, III, or IV disease as classified by the Ann Arbor Classification\n5. Age greater than or equal to 18 years\n6. ECOG performance status less than or equal to 2.\n7. Adequate organ and marrow function as defined below unless dysfunction is felt to be secondary to lymphoma involvement as determined by the treating investigator:\n\n   * absolute neutrophil count\\* \\>=1,000\u002FmcL\n   * hemoglobin\\* \\>= 8 g\u002FdL (transfusions permitted to meet criteria)\n   * Platelets \\>= 75,000\u002FmcL (transfusions not permitted)\n   * total bilirubin \\\u003C= 1.5 X institutional ULN (or \\\u003C= 3 X institutional ULN for patients with documented Gilberts syndrome or cholestatic obstruction or involvement by lymphoma)\n   * AST(SGOT)\u002FALT(SGPT) \\\u003C= 3 X institutional ULN (\\\u003C= 5 x ULN for patients with cholestatic obstruction or involvement by lymphoma\n   * Serum creatinine \\\u003C= 2.0 mg\u002FdL\n\n   OR\n\n   -Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above 2 mg\u002FdL\n\n   \\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n   NOTE: In patients without bone marrow involvement, transfusions of RBCs are permitted to achieve the criterion hemoglobin of 8g\u002Fdl, but transfusions of platelets are not permitted to achieve the criterion platelet count of \\>75,000\u002FmcL. In patients with bone marrow involvement, all transfusions are permissible at the discretion of the investigator.\n8. Effects of acalabrutinib on the developing human fetus are unknown. For these reasons the following measures apply:\n\n   * Individuals of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment.\n   * Individuals of childbearing potential who are sexually active must agree to highly effective contraception prior to study entry, for the duration of study participation, and for at least 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later. Individuals who can father children must use highly effective contraception prior to study entry, for the duration of study participation, and for 12 months after the last dose of combined chemotherapy; there is no contraception timing requirement post-last dose of acalabrutinib alone if an individual who can father children does not initiate chemotherapy on study after the acalabrutinib window.\n   * Participants must not be planning to conceive or father children within the projected duration of the trial, starting with the pre-screening\u002Fscreening visit through 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later.\n\n   NOTE: An individual is considered of childbearing potential, (i.e., fertile), following menarche and until becoming post-menopausal unless permanently sterile or have a congenital or acquired condition that prevents childbearing. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy at least 6 weeks before screening. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. In individuals of childbearing potential \\\u003C45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in individuals of childbearing potential not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient The investigator or a designated associate is requested to advise the subject how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence.\n\n   Individuals who can father children are considered to be of non-reproductive potential if they are permanently sterile due to bilateral orchiectomy.\n\n   Highly effective methods of contraception (to be used during heterosexual activity) are defined as methods that can achieve a failure rate of \\\u003C1% per year when used consistently and correctly. Such methods include:\n   * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal\n   * Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable\n   * Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)\n   * Bilateral tubal occlusion\n   * Vasectomy of participant or participant's partner (with medical assessment and confirmation of vasectomy surgical success)\n   * Sexual abstinence (only if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments)\n\n   Hormonal contraception may be susceptible to interaction with study or other drugs, which may reduce the efficacy of the contraception method.\n\n   Abstinence (relative to heterosexual activity) can only be used as the sole method of contraception if it is consistently employed during the entire period of risk associated with the study treatments.\n\n   Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, and post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n9. Ability of patient to understand and the willingness to sign a written informed consent document.\n10. Any HIV status will be included in this study; status must be confirmed prior to enrollment.\n\nEXCLUSION CRITERIA:\n\n1. Patients who meet histologic criteria for the following subtypes are excluded:\n\n   * Primary DLBCL of the central nervous system (PCNSL)\n   * Primary mediastinal B-cell lymphoma (PMBL)\n   * Plasmablastic lymphoma\n   * Intravascular large B-cell lymphoma\n   * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n2. Patients who, at the discretion of the investigator, need immediate cytoreductive chemotherapy such as patients with evidence of spontaneous tumor lysis or impending organ compromise are not eligible.\n3. Current or prior anti-cancer treatment for DLBCL prior to enrollment. Short course of corticosteroids (\\\u003C7 days) for acute issues prior to study enrollment are permitted.\n4. Major surgical procedure within 30 days of first dose of study drug. If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n5. Requires treatment with moderate or strong CYP3A inhibitors or inducers\n6. Known lymphomatous involvement of the CNS\n7. Pregnant individuals, or individuals who intend to become pregnant during the study are excluded from this study because of potential teratogenic effects associated with acalabrutinib, R-CHOP, and\u002For DA-EPOCH-R\n8. The potential for all study treatments to be excreted in the milk of nursing mothers is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with acalabrutinib, nursing must be discontinued.\n9. Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n   -Other malignancy that requires ongoing systemic hormonal therapy, chemotherapy, or immunotherapy.\n\n   Uncontrolled active systemic infection\n   * Any condition that requires anticoagulation with warfarin or equivalent vitamin K antagonist\n   * Active bleeding, history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)\n   * Suspected or confirmed Progressive Multifocal Leukoencephalopathy (PML)\n   * Active hepatitis C infection. NOTE: Subjects who are hepatitis C antibody positive will need to have a negative HCV PCR result before enrollment. Those with a positive PCR for hepatitis C are excluded.\n   * Active hepatitis B infection. NOTE: Patients who are hepatitis B surface antigen (HbsAg) positive will be excluded from enrollment. Patients who are hepatitis B core antibody (HbcAb) positive will need to have a negative HBV PCR result before enrollment. Those with a positive PCR for hepatitis B are excluded. Those who are hepatitis B core antibody (HbcAb) positive with a negative PCR for hepatitis B will be treated with antivirals designed to prevent hepatitis B reactivation (e.g., entecavir) throughout therapy and for 12 months after therapy and have monitoring for hepatitis B reactivation with PCR.\n   * History of hemorrhagic stroke or intracranial hemorrhage in preceding 6 months\n   * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled atrial fibrillation\u002Fflutter during screening are eligible.\n   * Uncontrolled autoimmune hemolytic anemia\n   * Inability to swallow oral medications, or disease involve that significantly limits absorption of oral medication\n   * Known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n10. Concurrent participation in another therapeutic clinical trial.","ALL","18 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nDiffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate.\n\nObjective:\n\nTo see if the drug acalabrutinib given with rituximab and standard combination chemotherapy can improve the cure rate of aggressive B-cell lymphomas such as diffuse large B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with an aggressive B-cell lymphomas that have not been treated\n\nDesign:\n\nParticipants will be screened with:\n\nBlood and urine tests\n\nPhysical exam\n\nMedical history\n\nTumor biopsy\n\nBone marrow biopsy: A needle will remove marrow from the participant s hipbone.\n\nLumbar puncture: If necessary, a needle will remove fluid from the participant s spinal canal.\n\nImaging scans\n\nParticipants will take the study drug for up to 14 days. It is a pill taken 2 times a day. Then they will have more scans. They will get rituximab and chemotherapy. They may get these drugs through a needle in an arm vein. Or they may them through a tube placed in a vein in their chest or in their neck. They might also keep taking the study drug. Each treatment cycle lasts 21 days. They will have up to 6 cycles.\n\nParticipants may have 4 doses of another drug injected into their spinal fluid.\n\nParticipants will have repeats of the screening tests throughout the study.\n\nParticipants will have a follow-up visit 30 days after their last treatment, then every 3 months for 2 years, then every 6 months for 3 years, and then yearly.",[27,28,29,30],"Non-Hodgkin's Lymphoma","Diffuse Large B-Cell Lymphoma","DLBCL","NHL",[32,33,34,35],"BTK Inhibitor","Calquence","ACP-196","Monoclonal Antibody","RECRUITING","2026-06-27",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2019-08-05",{"date":44,"type":21},"2031-03-31",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100418452","phase-2-efficacy-and-safety-of-nemtabrutinib-mk-1026-in-participants-with-hematologic-malignancies-mk-1026-003-100418452","NCT04728893","Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)","A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies","Inclusion Criteria:\n\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before C1D1 (the first dose of study treatment)\n* Has a life expectancy of at least 3 months, based on the investigator assessment\n* Has the ability to swallow and retain oral medication\n* Participants who are Hepatitis B surface antigen (HBsAg)-positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization\n* Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Has adequate organ function\n* Male participants agree to refrain from donating sperm and agree to either remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention\n* Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of childbearing potential (POCBP), or if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle during the intervention period and for at least to eliminate study intervention after the last dose of study intervention\n* Participants with Human immunodeficiency virus (HIV) are eligible if they meet all of the following: the CD4 count is \\>350 cells\u002FuL at screening, the HIV viral load is below the detectable level, are on a stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART\n\nPart 1 and Part 2 (Cohorts A to C and J)\n\n* Has a confirmed diagnosis of Chronic lymphocytic leukemia\u002F Small lymphocytic lymphoma (CLL\u002FSLL) with\n\n  * At least 2 lines of prior therapy (Part 1 only)\n  * Part 2 Cohort A: CLL\u002FSLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines\n  * Part 2 Cohort B: CLL\u002FSLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive\n  * Part 2 Cohort C: CLL\u002FSLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy\n  * Part 2 Cohort J: CLL\u002FSLL participants whose disease relapsed or was refractory to prior therapy with a covalent\u002Firreversible BTKi and BCL2i. NOTE: As of Protocol Amendment 09, at least 10 CLL\u002FSLL participants whose disease relapsed or was refractory to prior therapy with a covalent\u002Firreversible BTKi, BCL2i and noncovalent\u002Freversible BTKi (all three classes of therapies are required) will be enrolled into Cohort J\n  * Has active disease for CLL\u002FSLL clearly documented to initiate therapy\n  * For SLL participants in Part 2: Has evaluable core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate at Screening (optional for participants enrolling in Part 1)\n\nPart 2 (Cohorts D to G)\n\n\\- Has a confirmed diagnosis of and meets the following prior therapy requirements:\n\n* Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D)\n* Participants with pathologically confirmed Mantle-cell lymphoma (MCL), documented by either overexpression of cyclin D1 or t (11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)\n* Participants with Marginal zone lymphoma (MZL) (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to at least one prior line of systemic therapy including an anti-CD20-based regimen\n* Participants with Follicular lymphoma (FL) who are relapsed or refractory to chemoimmunotherapy and immunomodulatory agents (such as lenalidomide based regimen) (Cohort G)\n* Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral Computed tomography (CT) scan\n* Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate (Cohort D) at Screening\n\nPart 2 (Cohort H): confirmed diagnosis of Waldenström's macroglobulinemia (WM); participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi\n\n* Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease\n* Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be \\>15 mm in the longest diameter or \\>10 mm in the short axis); IgM ≥450 mg\u002FdL; or bone marrow infiltration of 10%\n* Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival\n\nExclusion Criteria:\n\n* Has active HBV\u002FHCV infection (Part 1 and Part 2)\n* Has a history of malignancy ≤3 years before providing documented informed consent. Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score ≤6, and prostate-specific antigen \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with SD are not excluded\n* Has active central nervous system (CNS) disease\n* Has an active infection requiring systemic therapy\n* Has received prior systemic anti-cancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before C1D1\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention\n* Has any clinically significant gastrointestinal abnormalities that might alter absorption\n* History of severe bleeding disorders",{"count":57,"type":21},490,[24],"The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)\u002F small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).",[61,62,63,64],"Hematologic Malignancies","Waldenstroms Macroglobulinaemia","Non-Hodgkins Lymphoma","Chronic Lymphocytic Leukaemia","2026-06-10",{"date":67,"type":40},"2026-06-12",{"date":69,"type":40},"2021-04-05",{"date":71,"type":21},"2029-01-04",{"name":73,"class":74},"Merck Sharp & Dohme LLC","INDUSTRY",121,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":48},"100637916","phase-1-safety-and-efficacy-of-ksvcbd-injection-in-b-cell-non-hodgkins-lymphoma-expressing-cd19-andor-bcma-100637916","NCT07620314","Safety and Efficacy of KSVCBD Injection in B-cell Non-Hodgkin's Lymphoma Expressing CD19 and\u002For BCMA","A Clinical Study on the Safety and Efficacy of KSVCBD Injection in the Treatment of B-cell Non-Hodgkin's Lymphoma With Positive Expression of CD19 and\u002For BCMA","Key Inclusion Criteria:\n\n1. Age 18-75 years (inclusive), any gender.\n2. Subjects must meet the following diagnostic and treatment criteria:\n\n   2.1Histologically or cytologically confirmed B-NHL (according to the 2016 WHO classification of lymphoid neoplasms):\n   * Diffuse large B-cell lymphoma, not otherwise specified.\n   * Primary mediastinal large B-cell lymphoma.\n   * Diffuse large B-cell lymphoma transformed from follicular lymphoma (TFL).\n   * High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements.\n   * Follicular lymphoma (FL).\n   * High-grade B-cell lymphoma, not otherwise specified.\n   * Mantle cell lymphoma (pathologically confirmed, with monoclonal B cells carrying t(11.14) and\u002For overexpressing cyclin D1).\n   * Marginal zone lymphoma (including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue \\[MALT\\] lymphoma).\n\n   2.2Subjects must be in a relapsed or refractory state during the screening period:\n   * Definition of relapse: Disease progression (PD) after achieving remission (including PR or CR) following at least one standard treatment regimen (must include rituximab).\n   * Definition of refractory: Must meet any of the following criteria:\n\n   Best response of stable disease (SD) or PD after at least 4 cycles of first-line standard treatment (e.g., 4 cycles of R-CHOP).\n\n   Achieved remission after at least 6 cycles of first-line standard treatment but experienced PD within 6 months.\n\n   Best response of PD after first-line standard treatment. Relapse (must be biopsy-proven) or PD within 12 months after autologous stem cell transplantation (ASCT). if salvage therapy was received, no response (SD or PD) to the last line of treatment.\n   * For TFL, subjects must have received adequate prior treatment for follicular lymphoma, at least one line of treatment for TFL after transformation, and be relapsed or refractory after the last line of treatment.\n   * For mantle cell lymphoma, prior treatment must include anthracycline- or bendamustine-containing chemotherapy, anti-CD20 therapy (except for CD20-negative cases), and BTK inhibitor therapy.\n   * For indolent lymphomas (grade 1-3a FL and marginal zone lymphoma), subjects must have received at least two prior lines of therapy.\n   * For other types, prior treatment must include anti-CD20 therapy (except for CD20-negative cases) and anthracycline-containing chemotherapy.\n\n   2.3Subjects judged by the investigator to be intolerant to standard therapy may also be included in the study.\n3. Intranodal lesion with long-axis diameter \\> 1.5 cm, or extranodal lesion with long-axis diameter \\> 1.0 cm (according to the 2014 Lugano response criteria).\n4. Positive expression of CD19 and\u002For BCMA in tumor tissue confirmed by flow cytometry and\u002For histopathology (previous pathology or flow cytometry diagnosis of CD19 and\u002For BCMA in the patient, as confirmed by the investigator, is acceptable). For subjects who have previously received anti-CD19 and\u002For anti-BCMA therapy, a tumor biopsy should be performed to confirm current positive expression of CD19 and\u002For BCMA.\n5. Toxicities from any prior therapy must be stable and have resolved to ≤ Grade 1 (excluding hematologic toxicities and clinically insignificant toxicities such as alopecia).\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n\nKey Exclusion Criteria:\n\n1. Expected survival \\\u003C 3 months.\n2. History of or concurrent active malignancy. Exceptions include: carcinoma in situ of the cervix that has been cured or with no recurrence for at least 3 years, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery.\n3. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT) or autologous HSCT within 3 months prior to KSVCBD infusion.\n4. Solitary extramedullary soft tissue plasmacytoma.\n5. Diagnosis of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.\n6. Presence of CNS metastasis or symptoms of CNS metastasis.\n7. Receipt of anti-tumor therapy that is still within 5 half-lives prior to the planned KSVCBD infusion.\n8. Presence of uncontrolled active infections.\n9. Positive for human immunodeficiency virus (HIV) antibody, positive for Treponema pallidum antibody, positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B core antibody (HBcAb) with detectable peripheral blood HBV DNA, or positive for hepatitis C virus (HCV) antibody with detectable HCV RNA. except for infections that the investigator judges can be prevented or controlled with medication.\n10. Known active autoimmune disease requiring systemic treatment.\n11. Known severe allergy to the study drug or any of its components.\n12. Pregnant or breastfeeding women.\n13. Receipt of a live vaccine within 6 weeks prior to enrollment.","75 Years",{"count":85,"type":21},9,[87],"PHASE1","KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r\u002Fr) B-cell non-Hodgkin's lymphoma (NHL) CD19 and\u002For BCMA.",[27],"2026-05-27",{"date":92,"type":40},"2026-06-02",{"date":94,"type":21},"2026-06-15",{"date":96,"type":21},"2029-03-30",{"name":98,"class":99},"Chinese PLA General Hospital","OTHER",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":48},"100067525","establishing-a-tumor-bank-in-families-with-multiple-lymphoproliferative-malignancies-100067525","NCT00131014","Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies","Establishing a Tumor Bank and Initial Analysis of Germline and Tumor-Related Genetic Alterations in Families With Multiple Lymphoproliferative Malignancies","Inclusion Criteria:\n\n* Any individual diagnosed with non-Hodgkin's lymphoma or Hodgkin's disease or chronic lymphocytic leukemia (CLL), who has a 1st degree relative (parent, sibling or child) with a lymphoproliferative disorder; or families in which the individual has a lymphoproliferative disorder, and an unusual clustering of frequent or premature solid tumors is also observed.\n* Family members of the individual, either affected or unaffected with lymphoma, who are contacted by the individual and agree to participate in the study.\n* Deceased family members may be included in the study. Public records such as death certificates may be used to confirm the history. Consent for medical records or tissue blocks will be obtained from the deceased family member's next of kin. The hierarchy of relatives defined as next of kin is spouse, offspring, parents and siblings. Archived tissue samples may be used for genetic research.\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Subjects without a family history of lymphoma",{"count":108,"type":21},1500,"OBSERVATIONAL","The purpose of this study is to investigate possible genetic factors that contribute to the development of lymphomas. The databank will be used to determine whether familial lymphomas have unique genetic characteristics different from sporadic lymphomas and to attempt to identify a gene that confers an increased risk of lymphoma.",[27,112,113,114],"Hodgkin's Disease","Leukemia, Lymphocytic, Chronic","Lymphoproliferative Disorders",[27,116,117,118,119],"Hodgkin's disease","Chronic Lymphocytic Leukemia","Lymphoproliferative disorder","Genetics","2026-04-21",{"date":122,"type":40},"2026-04-24",{"date":124,"type":40},"2004-08-09",{"date":126,"type":21},"2033-01",{"name":128,"class":99},"Dana-Farber Cancer Institute",{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":139,"studyType":109,"phases":4,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":48},"100200817","the-prospective-collection-storage-and-reporting-of-data-on-patients-undergoing-hematopoietic-stem-cell-transplantation-utilizing-a-standard-preparative-regimen-100200817","NCT01890486","The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen","The Prospective Collection, Storage and Reporting of Data on Patients","Inclusion Criteria:\n\nPlanned standard of care dose intensive therapy and either an allogeneic or autologous bone marrow transplant\n\nExclusion Criteria:\n\nParticipation in any other treatment research protocol","120 Years",{"count":138,"type":21},2000,"1 Year","To provide the IRB approved mechanism for the prospective collection and analysis on participants who are undergoing either an autologous or allogeneic hematopoietic stem cell transplant for a disease in which a research question is not being addressed.",[142,143,144,27,112,145,146,147,117,148],"Acute Myelogenous Leukemia","Acute Lymphocytic Leukemia","Chronic Myelogenous Leukemia","Multiple Myeloma","Germ Cell Neoplasms","Myelodysplastic Syndromes","Immunodeficiency Diseases","2026-04-09",{"date":151,"type":40},"2026-04-13",{"date":153,"type":40},"2001-05-21",{"date":155,"type":21},"2026-12",{"name":157,"class":99},"Wake Forest University Health Sciences",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":139,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":177,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100532125","phase-1-clic-2201-for-the-treatment-of-relapsedrefractory-b-cell-malignancies-100532125","NCT06208735","CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","CLIC-02: A Phase I Trial of CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","Inclusion Criteria in Cohort A:\n\nParticipants must meet the following criteria to be enrolled on the trial:\n\n1. Participants in the cohort A must be 18 years of age or older of age at time of informed consent.\n2. Participants must provide written informed consent.\n3. Participants must have a relapsed or refractory B cell lymphoma, including one of the following:\n\n   1. diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS),\n   2. high grade B cell lymphoma NOS,\n   3. high grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements,\n   4. primary mediastinal large B-cell lymphoma (PMBCL),\n   5. aggressive B cell lymphoma transformed from an indolent lymphoma,\n   6. mantle cell lymphoma (MCL),\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥40%,\n   2. Creatinine clearance using Cockcroft-Gault of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n6. Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky Score ≥50%.\n7. Females of child-bearing potential and sexually active males must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n8. Participants with accessible disease, must be willing to undergo a tumour biopsy at enrolment. For participants with a recent (within 3 months) tumor biopsy, access to the archival biopsy is acceptable.\n\nInclusion Criteria in Cohort B:\n\n1. Participants in the cohort B must be between 1-39 years of age at the time of consent.\n2. For participants who are under the age of consent as defined by REB requirements, parent or legal guardian of the participant must provide the informed consent and the participant's assent\u002Fconsent must be obtained (if applicable).\n3. Participants must have a relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL).\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants in cohort B and\u002For those who have received CD22 targeted therapy must have documentation of CD22 tumour expression within the 6 months prior to study screening, and after any prior CD22 directed therapy (if applicable).\n6. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥45%,\n   2. Creatinine clearance using Cockcroft-Gault or Schwartz equation of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n7. Participants must have a Karnofsky or Lansky Score ≥50%.\n8. Participants of reproductive age must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n9. Participants must be willing to undergo a bone marrow biopsy at enrolment.\n\nExclusion Criteria:\n\n1. Any uncontrolled or serious active infection at the time of enrolment.\n2. Active autoimmune disease requiring immunosuppressive therapy within 4 weeks of enrolment.\n3. Live vaccine ≤6 weeks prior to enrolment\n4. Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment.\n5. Diagnosis of primary central nervous system lymphoma (PCNSL)\n6. Treatment with any of the following in the specified time period before leukapheresis:\n\n   1. Allogeneic HCT within 3 months,\n   2. Autologous HCT within 3 months,\n   3. CD19 CAR-T cell infusion within 3 months,\n   4. Donor lymphocyte infusion (DLI) within 3 months,\n   5. Bendamustine within the last 6 months,\n   6. Any investigational agent within 30 days or 5 half-lives (whichever is shorter),\n   7. Systemic administration of therapeutic dose corticosteroids (\\>20 mg\u002Fday prednisone or equivalent for adults and ≥ 12 mg\u002Fm2\u002Fday for paediatric participants) within 7 days prior to leukapheresis.\n   8. Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks, unless used as treatment for the B cell malignancy.\n   9. Oral chemotherapy agents (i.e., venetoclax) within 5 half-lives. An exception to this is that bruton tyrosine kinase (BTK) inhibitors like ibrutinib can be continued in participants with mantle cell lymphoma throughout the trial period.\n7. Other concurrent malignancy or a prior malignancy treated within the past 2 years, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.\n8. Concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure or immunodeficiency syndrome.\n9. Active (confirmed by PCR) hepatitis B or hepatitis C at time of screening confirmed by PCR.\n10. Any Human Immunodeficiency Virus (HIV) infection at time of screening.\n11. Hypersensitivity to fludarabine or cyclophosphamide.\n12. Any allergy to gentamycin or its derivatives\n13. Participants who do not meet the minimum weight requirement for the planned dose level.\n14. Pregnant or nursing participants.",{"count":166,"type":21},24,[87],"This is a phase I dose-finding trial of an autologous CD22 targeting chimeric antigen receptor (CAR)-T cell product, called CLIC-2201, for participants with relapsed\u002Frefractory B cell malignancies. In the proposed trial, eligible enrolled participants will undergo leukapheresis for autologous T cell collection to enable CLIC-2201 manufacturing, followed by lymphodepletion with cyclophosphamide and fludarabine, then intravenous infusion of the autologous CLIC-2201 product. The trial will use the 3+3 design to escalate or de-escalate the dose level of CLIC-2201 administered. Participants will be monitored for safety and tolerability up to day 365 following CLIC-2201 infusion.\n\nThe primary objective is to evaluate the safety and tolerability of CLIC-2201 and estimate the maximum tolerated dose (MTD) of CLIC-2201 in B-cell malignancies.\n\nThe secondary objectives are to evaluate the (i) feasibility; (ii) anti-tumour activity of CLIC-2201; (iii) and characterize the pharmacokinetic (PK) profile of CLIC-2201.\n\nExploratory objectives will include: i) characterizing the cellular and humoral immune responses against CLIC-2201 up to 1 year following infusion of CLIC-2201; (ii) characterizing the phenotype and gene expression profile of CLIC-2201 cells; (iii) evaluating immune and tumour cells at baseline and relapse for biomarkers of response or toxicity; (iv) evaluating serum cytokines, circulating tumour DNA (ctDNA) and B cell aplasia as biomarkers of clinical outcomes; and (v) assessing the quality of life.",[170,27,171,172,173,174,175,176],"B-Cell Leukemia","B-cell Acute Lymphoblastic Leukemia","Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Mantle Cell Lymphoma","B-cell Lymphoma",[178,179,180,181,182],"Chimeric Antigen Receptor T cells","CLIC-2201","CD22","Immunotherapy","CAR-T cell","2026-03-30",{"date":185,"type":40},"2026-04-03",{"date":187,"type":40},"2025-01-02",{"date":189,"type":21},"2027-08-01",{"name":191,"class":99},"British Columbia Cancer Agency",7,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100175292","phase-1-cytotoxic-t-lymphocytes-for-ebv-positive-lymphoma-grale-100175292","NCT01555892","Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE","Administration of Rapidly Generated EBV-Specific Cytotoxic T-Lymphocytes To Patients With EBV-Positive Lymphoma","GRALE","Inclusion Criteria at time of Procurement\n\n1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)-T\u002FNK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV) who may subsequently be eligible for the treatment component\n2. EBV positive tumor (can be pending at this time)\n3. Weighs at least 12kg\n4. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\nInclusion Criteria at time of Infusion\n\n1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma (regardless of histologic subtype), or EBV (associated)-T\u002FNK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV)\\* and\n\n   In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse)\\*\\* OR any patient with primary disease or in first remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group A)\n\n   OR\n\n   In remission or with minimal residual disease status after autologous or syngeneic SCT. (Group B)\n2. EBV positive tumor\n3. Patients with bilirubin less than or equal to 3x upper limit of normal, AST less than or equal 5x upper limit of normal, and hemoglobin greater than or equal to 7.0 (may be a transfused value).\n4. Patients with a creatinine less than or equal to 2x upper limit of normal for age\n5. Pulse oximetry of \\> 90% on room air\n6. Patients should have been off other investigational therapy for 4 weeks prior to entry in this study. PD1\u002FPDL inhibitors will be allowed if medically indicated.\n7. Patients with a Karnofsky\u002FLansky score of greater than or equal to 50\n8. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded.\n9. Informed consent explained to, understood and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\n   * CAEBV is defined as patients with high EBV viral load in plasma or PBMC (\\> 4000 genomes per ug PBMC DNA) and\u002For biopsy tissue positive for EBV\n\n     * Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant.\n\nExclusion Criteria at Time of Procurement\n\n1\\. Active infection with HIV, HTLV, HBV, HCV (can be pending at this time)\n\nExclusion Criteria at Time of Infusion\n\n1. Pregnant or lactating\n2. Severe intercurrent infection.\n3. Current use of systemic corticosteroids \\> 0.5 mg\u002Fkg\u002Fday",{"count":202,"type":21},136,[87],"Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T\u002FNK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment, including the best treatment investigators know for these diseases.\n\nSome of these patients show signs of virus that is called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever (\"mono\" or the \"kissing disease\") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role in causing Lymphoma. The cancer cells and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called GRALE T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor.\n\nInvestigators have used this sort of therapy to treat a different type of cancer called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. Investigators grew T cells in the lab that recognized all 9 proteins and were able to successfully prevent and treat post transplant lymphoma. However, in HD and NHL, T\u002FNK-lymphoproliferative disease, and CAEBV, the tumor cells and B cells only express 4 EBV proteins. In a previous study, the investigators made T cells that recognized all 9 proteins and gave them to patients with HD. Some patients had a partial response to this therapy but no patients had a complete response. The investigators then did follow up studies where investigators made T cells that recognized the 2 EBV proteins seen in patients with lymphoma, T\u002FNK-lymphoproliferative disease and CAEBV. Investigators have treated over 50 people on those studies. About 60% of those patients who had disease at the time they got the cells had responses including some patients with complete responses. This study will expand on those results and the investigators will try and make the T cells in the lab in a simpler faster way. These cells are called GRALE T cells. These GRALE T cells are an investigational product not approved by the FDA.\n\nThe purpose of this study is to find the largest safe dose of LMP-specific cytotoxic GRALE T cells created using this new manufacturing technique. Investigators will learn what the side effects are and to see whether this therapy might help patients with HD or NHL or EBV associated T\u002FNK-lymphoproliferative disease or CAEBV.",[112,27,206,207],"Lymphoproliferative Disease","Lymphoma",[209,210,27,211,212,213,214,215,216],"EBV","Hodgkin's Lymphoma","Lymphoma Relapse","Autologous or Syngeneic Stem Cell Transplant","T\u002FNK-lymphoproliferative disease","LMP","BARF1","EBNA1","2026-02-26",{"date":219,"type":40},"2026-03-02",{"date":221,"type":40},"2013-01-14",{"date":223,"type":21},"2027-07-01",{"name":225,"class":99},"Baylor College of Medicine",3,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":234,"conditions":235,"keywords":241,"overallStatus":248,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":252,"locationsCount":4},"100295215","expanded-access-to-venetoclax-100295215","NCT03123029","Expanded Access to Venetoclax","Exclusion Criteria:\n\n* There are other suitable treatment options.\n* The participant qualifies for ongoing clinical trials.","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Venetoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[236,145,237,27,238,239,240],"Chronic Lymphocytic Leukemia (CLL)","Acute Myeloid Leukemia (AML)","Acute Lymphoblastic Leukemia (ALL)","Amyloidosis","Plasma Cell Leukemia",[242,243,244,245,246,247],"Expanded Access","Pre-approval Access","Compassionate Use","Special Access Program","Named Patient Basis","Special Access Scheme","AVAILABLE","2026-01-29",{"date":251,"type":40},"2026-01-30",{"name":253,"class":74},"AbbVie",{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"100567399","phase-1-study-to-evaluate-adverse-events-change-in-disease-activity-and-how-intravenously-infused-abbv-291-moves-through-the-body-in-adult-participants-with-non-hodgkins-lymphoma-100567399","NCT06667687","Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma","A Phase 1 First-In-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV 291 as Monotherapy and in Combination in Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* For dose escalation (Part 1) only: Participants must have documented diagnosis of B-cell malignancies including (but not limited to) the following, with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment:\n\n  * Mantle cell lymphoma (MCL);\n  * Marginal zone lymphoma (MZL);\n  * Waldenstrom macroglobulinemia (WM);\n  * Diffuse large b-cell lymphoma (DLBCL) (including: germinal center B-cell type, activated B-cell type, primary cutaneous DLBCL \\[leg type\\], Epstein-Barr virus-positive (EBV+) DLBCL \\[not otherwise specified\\], DLBCL associated with chronic inflammation, human herpesvirus 8-positive \\[HHV8+\\] DLBCL \\[not otherwise specified\\], B cell lymphoma \\[unclassifiable\\] with features intermediate between DLBCL and classical Hodgkin lymphoma, high-grade B-cell lymphoma \\[not otherwise specified\\], high-grade B-cell lymphoma \\[with MYC (avian myelocytomatosis viral oncogene homolog) and BCL2 and\u002For BCL6 rearrangements\\], DLBCL arising from follicular lymphoma \\[FL\\] \\[transformed FL\\]);\n  * FL Grades 1 to 3B;\n* For dose expansion (Part 2) only: Participants must have documented diagnosis of one of the following B-cell malignancies, with histology based on criteria established by the WHO, and measurable disease requiring treatment:\n\n  * Part 2a only: DLBCL (including: germinal center B-cell type, activated B-cell type, primary cutaneous DLBCL \\[leg type\\], EBV+ DLBCL \\[not otherwise specified\\], DLBCL associated with chronic inflammation, HHV8+ DLBCL \\[not otherwise specified\\], B-cell lymphoma \\[unclassifiable\\] with features intermediate between DLBCL and classical Hodgkin lymphoma, high-grade B-cell lymphoma \\[not otherwise specified\\], high-grade B-cell lymphoma \\[with MYC and BCL2 and\u002For BCL6 rearrangements\\], DLBCL arising from FL \\[transformed FL\\]);\n  * Part 2b only: FL Grades 1 to 3B;\n  * Part 2c only: Mantle cell lymphoma;\n* For all participants (Parts 1 and 2):\n\n  * Must be considered relapsed or refractory to, or intolerant of, at least 2 or more prior lines of therapy known to provide a clinical benefit for their condition, and for whom there is no appropriate locally available therapy known to provide clinical benefit (e.g., standard chemotherapy or autologous stem cell transplantation \\[ASCT\\]).\n  * Indolent non-Hodkin's lymphoma (NHL) participants must meet relevant disease specific requirements for treatment (e.g., National Comprehensive Cancer Network \\[NCCN\\], Groupe d'Etude des Lymphomes Folliculaires \\[GELF\\]).\n  * History of allogeneic stem cell transplantation must be stable off of immunosuppression for at least 3 months.\n  * For participants enrolled in backfill cohorts or at dose levels previously cleared, subjects must provide consent to an on-treatment fresh tumor biopsy from the same tumor lesion as the baseline tumor tissue. This requirement may be waived at the discretion of the contract research organization (CRO) Medical Monitor if collecting a biopsy would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator or could hinder a subject's ability to participate in the study.\n  * Previously treated with a CD79b-targeting therapy (e.g., CD79b monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD79b-targeting therapy must be collected. Tumor biopsy requirements may be modified by Sponsor during the study. This requirement may be waived at the discretion of the contract research organization (CRO) Medical Monitor if collecting a biopsy would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator or could hinder a subject's ability to participate in the study.\n\n    * CD79b expression status will be assessed in all participants.\n* Have an eastern cooperative oncology group (ECOG) Performance Status of 0 or 1.\n* Laboratory values meeting the criteria in the protocol within the screening period prior to the first dose of study drug (if multiple samples are drawn within the screening period, the sample\u002Fresult immediately prior to Cycle 1 Day 1 is applicable).\n* Availability of representative baseline tumor tissue (most recent archived tumor tissue or fresh biopsy collected during screening phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the CRO Medical Monitor if collecting a biopsy at screening would place the participant at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator or could hinder a participant's ability to participate in the study.\n\nExclusion Criteria:\n\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis.\n* Treatment with any of the following:\n\n  * Anticancer therapy including chemotherapy, radiotherapy, small molecule, investigational, and biologic agents within 14 days (or at least 5 half-lives, whichever is shorter), prior to the first dose of the study treatment;\n  * CD79b-directed agents (e.g., CD79b monoclonal antibody therapy) within 4 weeks (or at least 5 half-lives, whichever is shorter) prior to the first dose of study treatment.\n  * Prior treatment with an antibody drug conjugate that consists of a topoisomerase I inhibitor.",{"count":262,"type":21},165,[87],"Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or refractory (R\u002FR) NHL, including but not limited to diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Adverse events will be assessed.\n\nABBV-291 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)\u002FMaximum tolerated dose (MTD) of ABBV-291 and a dose expansion\u002Foptimization phase to determine the change in disease activity in participants with R\u002FR NHL. Approximately 165 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide\n\nIn the dose escalation phase of the study participants will receive escalating Intravenously (IV) infused doses of ABBV-291, until the MAD\u002FMTD is determined. In the dose expansion\u002Foptimization phase of the study participants receive IV infused ABBV-291, as part of the approximately 74 month study duration.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.",[27],[267,28,175,268,269,270,271,272,30,29,273,274,275,276,277,278,279,280],"Non-Hodgkin's Lymphomas","Follicular Lymphoma","Marginal Zone Lymphoma","Waldenstroms Macrogloulinemia","Germinal Center B-cell","Activated B-Cell","MCL","FL","MZL","WM","GCB","ABC","Cancer","ABBV-291","2026-01-22",{"date":283,"type":40},"2026-01-26",{"date":285,"type":40},"2025-01-16",{"date":287,"type":21},"2031-11",{"name":253,"class":74},14,{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":318},"100556059","phase-3-comparison-study-of-eap-and-disease-specific-chemotherapy-regimens-in-hematopoietic-stem-cell-mobilization-for-lymphoma-100556059","NCT06520163","Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma","A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety of Etoposide, Cytarabine, and PEG-rhG-CSF Combination Therapy vs. Disease-Specific Chemotherapy for Hematopoietic Stem Cell Mobilization in Lymphoma","Inclusion Criteria:\n\n* Diagnosed with non-Hodgkin's lymphoma before enrollment.\n* Indication for autologous stem cell transplantation (ASCT).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0\\~1.\n* Achieved complete remission after multiple courses of chemotherapy.\n* Life expectancy ≥ 3 months.\n* Subjects must be able to understand the protocol and sign the informed consent.\n\nExclusion Criteria:\n\n* Cardiac function class II or higher or cardiac ejection fraction \\\u003C 40%.\n* Serum direct bilirubin (DBIL) more than twice of the upper limit of normal (ULN).\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than three times the upper limit of normal (ULN).\n* Serum creatinine clearance rate ≤ 50%.\n* Patients with active infection.\n* History of prior hematopoietic stem cell mobilization.",{"count":298,"type":21},99,[300],"PHASE3","This study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) combination therapy (EAP regimen) in mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma (NHL). A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen. The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×10\\^6\u002Fkg).",[27,303],"Hematopoietic Stem Cell Mobilization",[27,305,306,307],"Disease-Specific Chemotherapy","Hematopoietic stem cell mobilization","Etoposide, Cytarabine Combined with PEG-rhG-CSF","2025-11-27",{"date":310,"type":40},"2025-12-04",{"date":312,"type":40},"2024-08-01",{"date":314,"type":21},"2026-08",{"name":316,"class":317},"The Affiliated People's Hospital of Ningbo University","OTHER_GOV",17,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":329,"studyType":109,"phases":4,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":342},"100276031","gmall-registry-and-collection-of-biomaterial-prospective-data-collection-regarding-diagnosis-treatment-and-outcome-of-adult-acute-lymphoblastic-leukemia-all-patients-and-related-diseases-associated-with-a-prospective-collection-of-biomaterial-100276031","NCT02872987","GMALL Registry and Collection of Biomaterial: Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult Acute Lymphoblastic Leukemia (ALL) Patients and Related Diseases Associated With a Prospective Collection of Biomaterial","Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial","GMALLregistry","Inclusion Criteria:\n\n* Acute Lymphoblastic Leukemia (All Subtypes) if treated according to ALL protocols\n* Other Types of Leukemia (NK Cell Lymphoma\u002FLeukemia, Biphenotypic Acute Leukemia) if treated according to ALL protocols\n* Non-Hodgkin's Lymphoma of Following Subtypes: Burkitt Lymphoma, B Cell Lymphoma, B- or T-lineage Lymphoblastic Lymphoma, Anaplastic Large Cell Lymphoma, Other NHL) if treated according to B-ALL protocols\n* Age minimum 18 yrs",{"count":328,"type":21},10000,"15 Years","The GMALL registry serves the purpose of ALL research and quality assurance. The Registry collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical routine, whether or not the patient is treated within a clinical trial.",[332,333,27],"Acute Lymphoblastic Leukemia","Leukemia",{"date":335,"type":40},"2025-12-05",{"date":337,"type":4},"2009-02",{"date":339,"type":21},"2035-12",{"name":341,"class":99},"Goethe University",152,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":48},"100400600","phase-2-a-study-evaluating-apg-115-as-a-single-agent-or-in-combination-with-apg-2575-in-subjects-with-rr-t-pll-and-nhl-100400600","NCT04496349","A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R\u002FR T-PLL and NHL","A Phase IIa Study Evaluating the Pharmacokinetics, Safety and Efficacy of APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With Relapsed\u002FRefractory T-Cell Prolymphocytic Leukemia (R\u002FR T-PLL) or Non-Hodgkin's Lymphoma (NHL).","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Patients with relapsed\u002Frefractory T-PLL who have active disease and have received at least one prior therapy; Patients with histologically confirmed diagnosis of NHL, NHL Patients must be either relapsed, refractory, intolerant, or are considered ineligible for therapies known to provide clinical benefit;\n3. Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting APG-115 and\u002For APG-2575. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.\n4. Absolute neutrophil count (ANC) ≥ 500\u002Fmm˄3; hemoglobin ≥ 60 g\u002FL; platelet count ≥ 30,000\u002Fmm˄3\n5. Patients with adequate organ function;\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n7. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his\u002Fher legally authorized representative is required prior to their enrollment on the protocol.\n\nExclusion Criteria:\n\n1. Patient previously treated with a murine double minute 2 (MDM2) inhibitor.\n2. Known active, uncontrolled central nervous system (CNS) malignancy\n3. Patients require graft versus host therapy, or require continued treatment with systemic immunosuppressive agents (calcineurin inhibitors within 4 weeks prior to the first dose of study drug).\n4. Patients who have any conditions or illness that, according to the opinions of the Investigators or the medical monitor, would compromise patient safety or interfere with the evaluation of safety and efficacy to the study drug(s).\n5. Patients who have used strong CYP2C8 inhibitors, or moderate or strong CYP3A4 inhibitors or inducers within washout period of 14 days or 7 half-lives before the first administration of study drugs, whichever is longer.",{"count":351,"type":21},78,[24],"The goal of this study is to evaluate the pharmacokinetics (PK), safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients with T-PLL and NHL.",[355,63],"T-Prolymphocytic Leukemia","2025-11-03",{"date":358,"type":40},"2025-11-04",{"date":360,"type":40},"2021-07-12",{"date":362,"type":21},"2027-05-31",{"name":364,"class":74},"Ascentage Pharma Group Inc.",{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100274133","id-of-prognostic-factors-in-mycosis-fungoidessezary-syndrome-100274133","NCT02848274","ID Of Prognostic Factors In Mycosis Fungoides\u002FSezary Syndrome","Prospective Multicenter International Observational Study for Determination of a Cutaneous Lymphoma International Prognostic Index Model and Impact of Major Therapies in Patients With Advanced Mycosis Fungoides and Sézary Syndrome","Inclusion Criteria\n\n* Diagnosis of advanced stage MF or SS (Stages IIB - IVB) within 6 months of presentation to the participating center\n* Patients that are expected to have care administered at the participating center or jointly with referring physician(s) where follow-up data would be available\n\nExclusion Criteria\n\n* Patients diagnosed with early stage MF\u002FSS (Stages IA-IIA) before progressing to advanced stage\n* Patients diagnosed with advanced MF\u002FSS more than 6 months prior to initial presentation to the participating center\n* Exclude one-time consultation type of new patients.",{"count":138,"type":21},"The purpose of the study is to develop a prognostic index model for the rare disease of mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical data at various institutions. The investigators hope this will enable the identification of low- and high-risk groups for survival in order to improve patient care and outcome.",[375,27],"Mycosis Fungoides","2025-10-20",{"date":378,"type":40},"2025-10-22",{"date":380,"type":40},"2016-10",{"date":382,"type":21},"2027-03",{"name":384,"class":99},"Stanford University",13,{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":399,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":226},"100608476","phase-2-role-of-antibiotic-therapy-or-immunoglobulin-on-infections-in-haematology-platform-trial-rational-pt-100608476","NCT07202052","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)","A Randomised Platform Trial Evaluating the Role of Interventions to Prevent Infection in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies - RATIONAL-PT (Core)","Inclusion Criteria:\n\n1. Aged greater than or equal to 18 years of age\n2. Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.\n3. Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replacement for history of recurrent or severe infection(s) and IgG less than the lower limit of the reference range (excluding paraprotein) OR IgG\\\u003C4g\u002FL (excluding paraprotein)\n4. Life expectancy \\> 12 months\n5. Able to give informed consent\n\nExclusion Criteria:\n\n1\\. Treating team deems enrolment in the study is not in the best interests of the patient.",{"count":394,"type":21},900,[24,300],"This is an adaptive platform study to find out how safe and effective different strategies are in comparison to each other, for preventing infection in patients with blood cancers.\n\nIt is a comparison between Immunoglobulin and antibiotics use.",[398,27,333],"Myeloma",[400,401,402,403,404,405,406,407,408,409,410],"immunoglobulin","antibiotics","myeloma","leukaemia","lymphoma","non Hodgkins","infection","infections","blood","cancer","haematology","2025-10-01",{"date":413,"type":40},"2025-10-07",{"date":415,"type":40},"2025-05-06",{"date":417,"type":21},"2027-03-31",{"name":419,"class":99},"Monash University",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":48},"100521177","phase-1-a-study-of-gnc-035-in-relapsed-or-refractory-non-hodgkin-s-lymphoma-and-other-hematological-malignancies-100521177","NCT06066203","A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies","An Open, Multicenter, Phase I \u002F II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics \u002F Pharmacodynamics and Antitumor Activity of GNC-035 Tetra-specific Antibody Injection in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies","Inclusion Criteria:\n\n1. The subject is able to understand the informed consent form, voluntarily participates, and signs the informed consent form;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Histologically or cytologically confirmed relapsed or refractory non-Hodgkin's lymphoma;\n6. For patients with relapsed or refractory non-Hodgkin's lymphoma, specifically including: Patients who have failed at least one line of standard therapy; Patients with relapsed or refractory disease judged by the investigator to have no other available or suitable treatment options;\n7. For non-Hodgkin's lymphoma, at least one measurable lesion meeting the Lugano response criteria must be present during the screening period;\n8. ECOG performance status score ≤2;\n9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n10. Organ function levels meet the requirements within 7 days before the first dose;\n11. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. Female subjects of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose;\n12. The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Patients who have undergone major surgery within 28 days prior to the administration of this study or are scheduled for major surgery during the study period (major surgery is defined by the investigator);\n2. Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0;\n3. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;\n4. Patients with active autoimmune diseases;\n5. History of other malignancies within 5 years prior to the first dose;\n6. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection;\n7. Poorly controlled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg) despite medication;\n8. History of severe cardiovascular or cerebrovascular diseases;\n9. Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-035;\n10. Pregnant or lactating women;\n11. Patients with central nervous system involvement;\n12. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n13. Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-035 treatment;\n14. Current use of immunosuppressive therapy;\n15. Radiotherapy or macromolecular targeted therapy within 4 weeks before initiating GNC-035 treatment; chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is shorter) before treatment;\n16. Anti-CD20 or anti-CD79b treatment within 4 weeks before initiating GNC-035 treatment with ongoing response;\n17. CAR-T therapy within 12 weeks before initiating GNC-035 treatment;\n18. Use of investigational drugs from other clinical trials within 4 weeks or 5 half-lives (whichever is shorter) before the administration of this study;\n19. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.",{"count":428,"type":21},40,[87,24],"Phase I main objectives: To observe the safety and preliminary efficacy of GNC-035 in patients with relapsed\u002Frefractory non-Hodgkin lymphoma and other hematological malignancies, to determine the DLT and MTD, or MAD, and to determine RP2D. Phase II Main objective: To explore the efficacy of GNC-035 in patients with relapsed\u002Frefractory non-Hodgkin lymphoma and other hematological malignancies.",[432],"Non-hodgkin's Lymphoma",[434],"Hematological malignancies","2025-09-26",{"date":411,"type":40},{"date":438,"type":40},"2023-11-01",{"date":440,"type":21},"2027-12",{"name":442,"class":74},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":451,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":226},"100487200","phase-1-a-study-of-gnc-038-injection-in-patients-with-relapsed-or-refractory-non-hodgkins-lymphoma-100487200","NCT05623982","A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma","An Open, Multicenter, Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)","Inclusion Criteria:\n\n1. The subject is capable of understanding the informed consent form, voluntarily participates, and signs the informed consent form;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Patients with histologically confirmed non-Hodgkin's lymphoma;\n6. Patients with relapsed or refractory non-Hodgkin's lymphoma (R\u002FR NHL);\n7. Presence of measurable lesions during the screening period (lymph node lesions with any long diameter ≥1.5 cm or extranodal lesions with any long diameter \\>1.0 cm);\n8. ECOG performance status score ≤2;\n9. Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as per CTCAE 5.0 criteria;\n10. Organ function levels meet the requirements before the first dose;\n11. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 12 weeks after treatment discontinuation. Female subjects of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose;\n12. The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently diagnosed with interstitial lung disease (ILD);\n2. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;\n3. Active tuberculosis;\n4. Patients with active autoimmune diseases;\n5. History of other malignancies within 5 years prior to the first dose;\n6. HBsAg-positive and\u002For HBcAb-positive with HBV-DNA levels ≥ the lower limit of detection; HCV antibody-positive with HCV-RNA levels ≥ the lower limit of detection; HIV antibody-positive;\n7. Poorly controlled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg);\n8. History of severe cardiovascular or cerebrovascular diseases;\n9. Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-038;\n10. Pregnant or lactating women;\n11. Patients with central nervous system involvement;\n12. Major surgery within 28 days before the first dose of this study or planned major surgery during the study period;\n13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n14. Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-038 treatment;\n15. Current use of immunosuppressive therapy;\n16. Radiotherapy within 4 weeks before initiating GNC-038 treatment;\n17. Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives prior to treatment;\n18. CAR-T therapy within 12 weeks before initiating GNC-038 treatment;\n19. Use of any other investigational drug in a clinical trial within 4 weeks or 5 half-lives before the first dose of this study;\n20. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.",{"count":428,"type":21},[87,24],"To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT",[432],{"date":455,"type":40},"2025-09-29",{"date":457,"type":40},"2022-09-26",{"date":440,"type":21},{"name":442,"class":74},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":467,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":478,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":48},"100507203","phase-2-cord-blood-transplant-in-adults-with-blood-cancers-100507203","NCT05884333","Cord Blood Transplant in Adults With Blood Cancers","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults","Inclusion Criteria:\n\n* I. Acute myelogenous leukemia (AML):\n* Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n  * Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPD).\n  * Therapy-related AML.\n  * Presence of extramedullary leukemia at diagnosis.\n  * Requirement for 2 or more inductions to achieve CR1.\n  * Intermediate or high ELN2017 genetic risk AML.\n  * Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician.\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or greater (CR2+).\n* Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible\n\nII. Acute lymphoblastic leukemia (ALL):\n\n* Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n  * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n  * Failure to achieve MRD- complete remission after induction therapy.\n  * Persistence or recurrence of minimal residual disease on therapy.\n  * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or greater (CR2+). Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n\nIII. Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n\nIV. Myelodysplastic Syndromes (MDS) and Myeloproliferative Disorders (MPD) other than myelofibrosis:\n\n* International prognostic scoring system (IPSS) risk score of INT-2 or high risk at the time of diagnosis.\n* Any IPSS risk category if life-threatening cytopenia(s) exists.\n* Any IPSS risk category with karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia.\n* MDS\u002FMPD overlap syndromes without myelofibrosis.\n* MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and ANC \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n\nV. Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\nEligible patients with aggressive histologies (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histologies) in CR by PET\u002FCT imaging.\n\no Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2 nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n\nVI. Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n\nOrgan Function and Performance Status Criteria:\n\n* Karnofsky score equal or greater than 80% (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* ALT \\\u003C 3 x upper limit of normal (ULN).\n* Pulmonary function: Spirometry (FVC and FEV1) and corrected DLCO) \\> 60% predicted.\n* Left ventricular ejection fraction (MOD-bp)\\> 50%.\n* Albumin \\> 3.0.\n* Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) ≤5.\n\nGraft criteria:\n\nTwo CB units will be selected according to current MSKCC CB unit selection algorithm. High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed. Unit selection will occur based on HLA-match, total nucleated cell (TNC) and CD34+ cell dose adjusted per patient body weight. The bank of origin will also be considered. Donor specific HLA antibodies, if present, will also be taken into consideration and may influence the selection of the graft.\n\n* Each CB unit must be at least 3\u002F8 HLA-matched to the patient considering high-resolution 8-allele HLA typing. \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 10\\^7 TNC\u002F recipient body weight (TNC\u002F kg). \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.5 x 10\\^5 CD34+ cells\u002F recipient body weight (CD34+ cells\u002Fkg). \\[Taken from the Cord Blood Summary\\]\n* A minimum of one unit will be reserved as a backup graft. \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to be cryopreserved in standard cryovolume (24-27 ml\u002Fs per unit or per bag if unit in two bags) and be red blood cell depleted. \\[Taken from the Cord Blood Summary\\]\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients with persistent with CNS involvement in CSF or CNS disease at time of screening\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy TBI in the opinion of Radiation Oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Seropositivity for HTLV-1.\n* Inadequate performance status\u002F organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.","21 Years","65 Years",{"count":470,"type":21},54,[24],"Cord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK has developed a standard (\"optimized\") practice for cord blood transplant (CBT). This optimized practice includes how patients are evaluated for transplant, the conditioning treatment (standard chemotherapy and total body irradiation therapy) given to prepare the body for transplant, the amount of stem cells transplanted, and how patients are followed during and after transplant.The purpose of this study is to collect information about participant outcomes after CBT following MSK's optimized practice. The researchers will look at outcomes of the CBT treatment such as side effects, disease relapse, GVHD, and immune system recovery after CBT treatment.",[474,238,475,476,477,27],"Acute Myelogenous Leukemia (AML)","Chronic Myelogenous Leukemia (CML)","Myelodysplastic Syndromes (MDS)","Myeloproliferative Disorder",[479,480,481,482,483,484,485],"Cord Blood Transplant","CYCLOPHOSPHAMIDE (CYTOXAN)","CYCLOSPORINE A","FLUDARABINE","MYCOPHENOLATE MOFETIL (MMF)","THIOTEPA","23-143","2025-09-05",{"date":488,"type":40},"2025-09-08",{"date":490,"type":40},"2023-05-22",{"date":492,"type":21},"2028-05-22",{"name":494,"class":99},"Memorial Sloan Kettering Cancer Center",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":505,"briefSummary":506,"conditions":507,"keywords":508,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":226},"100344477","phase-1-clic-1901-for-the-treatment-of-patients-with-relapsedrefractory-cd19-positive-hematologic-malignancies-100344477","NCT03765177","CLIC-1901 for the Treatment of Patients With Relapsed\u002FRefractory CD19 Positive Hematologic Malignancies","Canadian-Led Immunotherapies in Cancer: CLIC-1901 for the Treatment of Patients With Relapsed\u002FRefractory CD19 Positive Hematologic Malignancies","CLIC-01","Inclusion Criteria:\n\n1. Participant must have relapsed or refractory CD19+ disease as defined by one of the following:\n\n   a. Relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia as defined by one of the following: i. Second or greater relapse ii. Any relapse after allogeneic stem cell transplantation (SCT) iii. Chemorefractory as defined by not achieving CR after 2 cycles of a standard induction chemotherapy or one cycle of salvage therapy b. Histologically confirmed B-cell non-Hodgkin's lymphoma including but not limited to diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, or transformed follicular lymphoma, Richter's, Burkitt's or Mantle Cell lymphoma with one of the following: i. Second or greater relapse ii. Any relapse after autologous or allogeneic SCT iii. Chemorefractory as defined by not achieving CR after 2 cycles of a standard chemotherapy or one cycle of salvage therapy\n2. All eligible participants must have documentation of CD19 tumour expression demonstrated in tissue biopsy, bone marrow or peripheral blood within the 3 months prior to study screening.\n3. Adequate organ function\n4. Participant age: 18 to 75 years.\n5. Provide written informed consent\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Isolated extra-medullary disease.\n2. Participants with concomitant genetic syndrome, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known familial bone marrow failure syndrome.\n3. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.\n4. Prior treatment with any gene therapy product.\n5. Participants with polymerase chain reaction (PCR) positive hepatitis B, hepatitis C, or Human Immunodeficiency Virus (tested within 8 weeks of screening), or any uncontrolled infection at screening.\n6. Presence of active Graft Versus Host Disease requiring systemic therapy.\n7. Participants who have undergone allogeneic SCT less than 6 months prior to CLIC-1901 cell infusion or who have undergone donor lymphocyte infusion less than 6 weeks prior to CLIC-1901 cell infusion.\n8. Active Central Nervous System (CNS) involvement by malignancy, defined by CNS-3 per National Comprehensive Cancer Network guidelines.\n9. History of anaphylaxis to gentamicin or its derivatives.\n10. Participant has received an investigational agent within the 30 days prior to enrolment visit.\n11. Pregnant or nursing women.",{"count":504,"type":21},60,[87,24],"The investigators propose an early phase study defined as a phase I\u002FII trial assessing safety, feasibility and efficacy of CLIC-1901 autologous anti-CD19 Chimeric Antigen Receptor T cells (CAR-T) cells for participants with relapsed\u002Frefractory CD19 positive (CD19+) Acute Lymphoblastic Leukemia (ALL) and non-Hodgkin's Lymphoma (NHL). The Initial Stage of the study (n=20 participants) will focus on feasibility and safety while the Extended Stage will include all participants enrolled in the study (n=additional 80 participants for a total of 100) and will focus on efficacy and safety outcomes. In the proposed trial, we will administer our CAR-T cell product to these participants as a single infusion. Participants will undergo (a) lymphodepletion with cyclophosphamide and fludarabine, followed by (b) infusion of autologous CLIC-1901 CAR-T cells. All treatments will be delivered intravenously.",[332,27,117],[178,509,510],"CLIC-1901","anti-CD19 CAR-T cells","2025-08-13",{"date":513,"type":40},"2025-08-14",{"date":515,"type":40},"2019-10-16",{"date":517,"type":21},"2042-06-30",{"name":519,"class":99},"Ottawa Hospital Research Institute",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":545,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":557},"100542472","phase-1-t-cell-therapy-eb103-in-adults-with-relapsedrefractory-b-cell-non-hodgkins-lymphoma-nhl-100542472","NCT06343311","T-Cell Therapy (EB103) in Adults With Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (NHL)","An Open-Label, Dose Escalation, Multi-Center Phase I\u002FII Clinical Trial of EB103 T-Cell Therapy in Adults With Relapsed\u002FRefractory (R\u002FR) B-Cell Non-Hodgkin's Lymphoma (NHL)","STARLIGHT-1","Inclusion Criteria:\n\n* Age 18 years or older at the time of informed consent\n* Histologically confirmed R\u002FR B-cell non-Hodgkin's lymphoma (NHL)\n* Adequate organ function\n* Relapsed or refractory (R\u002FR) disease defined as ONE OR MORE of the following:\n\n  * R\u002FR after ≥ 2 lines of systemic therapy\n\n    * For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R\u002FR after ≥ 1 lines of systemic therapy\n  * Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)\n  * For subjects who are considered transplant-ineligible: progressive disease as best response after ≥ 4 cycles of first-line therapy and stable disease as best response after ≥ 2 cycles of second-line (salvage) therapy; subject must have received an anti-CD20 monoclonal antibody and an anthracycline as one of their qualifying regimens\n* All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:\n\n  * Anti-CD20 monoclonal antibody AND\n  * An anthracycline-containing chemotherapy regimen\n* Positron emission tomography (PET)-positive disease according to Cheson 2014\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Toxicities due to prior therapy must be stable and recovered to Grade 1 or less\n\nExclusion Criteria:\n\n* Prior CD19-targeted cellular therapy\n* History of Richter's transformation of chronic lymphocytic leukemia (CLL)\n* History of another primary malignancy that has not been in remission for ≥ 2 years.\n* History or presence of clinically relevant Central Nervous System (CNS) pathology\n* CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms\n* Subjects with active cardiac lymphoma involvement which is not responding to treatment\n* History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent\n* Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n* History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years\n* History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents\n* Venous thrombosis or embolism not managed on a stable regimen of anticoagulation\n* Autologous HSCT within 3 months of informed consent\n* Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening\n* Live vaccine within 3 months prior to planned start of conditioning regimen",{"count":529,"type":21},21,[87,24],"This is an open-label, dose escalation, multi-center, Phase I\u002FII clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed\u002Frefractory (R\u002FR) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase.",[533,534,535,536,27,537,538,207,539,540,541,542,543,173,544],"B-Cell Non-Hodgkin's Lymphoma (NHL)","Lymphoma, Non-Hodgkins","Lymphomas Non-Hodgkin's B-Cell","Non-Hodgkin Lymphoma","Large B-Cell Lymphoma","Lymphoma, Non-Hodgkin's, Adult","Refractory Non-Hodgkin Lymphoma","Relapsed Non-Hodgkin Lymphoma","Lymphoma, Non-Hodgkin","HIV Associated Lymphoma","CNS Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma",[546,27,30,207,537,539,540,547,543,173,544],"B-Cell Non-Hodgkin's Lymphoma","HIV Lymphoma","2025-08-04",{"date":550,"type":40},"2025-08-07",{"date":552,"type":40},"2024-06-01",{"date":554,"type":21},"2027-12-31",{"name":556,"class":74},"Estrella Biopharma, Inc.",2,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":580,"locationsCount":557},"100481893","phase-1-allogenic-cd19-targeting-car-t-cell-therapy-in-rr-nhl-100481893","NCT05554939","Allogenic CD19-targeting CAR-γδT Cell Therapy in R\u002FR NHL","A Phase 1\u002F2 Clinical Trial of Gene-edited Allogenic CD19 Targeting Chimeric Antigen Receptor-γδT Cells Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma","Inclusion Criteria for patients:\n\n1. Age 18-75 (inclusive).\n2. Patients with histologically confirmed CD19-positive B-cell NHL, including the following types defined by the World Health Organization (WHO) 2016:\n\n   * Diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), including Activated B-cell type (ABC）\u002FGerminal center B-cell type（GCB）;\n   * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL);\n   * Transformed follicular lymphoma (TFL);\n   * High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements (HGBCL);\n   * Follicular lymphoma (FL);\n   * Mantle cell lymphoma (MCL) (pathologically confirmed, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and\u002For overexpress cyclin D1);\n   * Marginal zone lymphoma (MZL), including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue (MALT) lymphoma.\n3. Relapse after treatment with ≥2 lines systemic therapy for all the above disease types, or refractory disease for aggressive types (DLBCL-NOS, PMBCL, TFL and HGBCL). Relapse disease is defined as disease progression after last regimen. Refractory disease is defined as no CR to first-line therapy:\n\n   * PD as best response to first-line therapy, or\n   * SD as best response after at least 4 cycles of first-line therapy (eg,4 cycles of R-CHOP), or\n   * PR as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 6 months of therapy, or\n   * Refractory post-autologous stem cell transplant (ASCT) i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy.\n4. Individuals must have received adequate prior therapy:\n\n   * For MCL, prior therapy must have included:\n\n     * Anthracycline or bendamustine-containing chemotherapy and\n     * Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative) and\n     * Bruton's tyrosine kinase inhibitor (BTKi)\n   * For other types, prior therapy must have included:\n\n     * Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative) and\n     * Anthracycline containing chemotherapy regimen.\n   * For individual with transformed FL must have relapse or refractory disease after transformation to DLBCL.\n5. The estimated survival time is over 3 months.\n6. The Eastern Cooperative Oncology Group (ECOG) score is 0-2.\n7. According to Lugano response criteria 2014, there should be at least one evaluable tumor focus. Evaluable tumor focus was defined as that with the longest diameter of intranodal focus \\> 1.5cm, the longest diameter of extranodal focus \\> 1.0cm assessed by computed tomography (CT) or magnetic resonance imaging (MRI).\n8. Subjects must be willing to undergo either excised or large-needle lymph node or tissue biopsy, or provide formalin-fixed paraffin-embedded (FFPE) tumor tissue block or freshly cut unstained slides.\n9. Functions of important organs meet the following requirements: Echocardiography showed left ventricular ejection fraction ≥50%. Serum creatinine ≤1.5 × upper limit of normal range (ULN) or endogenous creatinine clearance ≥45mL\u002Fmin (cockcroft-gault formula); Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤3 times ULN, Total bilirubin ≤1.5× ULN; Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) ≥91% in indoor air environment.\n10. Blood routine (normal values shall not be obtained with growth factors, and hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions below): hemoglobin (Hgb) ≥80g\u002FL, neutrophil count≥1×10\\^9\u002FL, platelet (PLT) ≥75×10\\^9\u002FL.\n11. Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.\n12. Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or to an acceptable level of inclusion\u002Fexclusion criteria (other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject).\n13. No obvious hereditary diseases.\n14. Able to understand the requirements and matters of the trial, and willing to participate in clinical research as required.\n15. Informed consent must be signed.\n\nExclusion Criteria for patients:\n\n1. During the screening period, there was central nervous system (CNS) invasion or a history of clinically significant central nervous system diseases, such as epilepsy and cerebrovascular diseases.\n2. Women who are pregnant or breastfeeding, or who do not agree to use effective contraception during treatment and during the subsequent 1 year.\n3. History of allogeneic hematopoietic stem cell transplantation, or organ transplantation.\n4. History of other malignancies that have not been in remission.\n5. Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy.\n6. Received radiotherapy within 3 months before enrollment.\n7. Received immunotherapy drugs within 4 weeks before enrollment, such as anti-programmed death 1 (PD-1) antibody, anti-programmed death ligand 1 (PD-L1) antibody, CD19\u002FCD3-bispecific antibody, and so on.\n8. Patients who received any immunocellular therapy within 3 months before enrollment.\n9. Confirmed evidence showing positiveness of anti-CD19 scFv reaction in patient serum.\n10. Patients who participated in other clinical trials within 4 weeks prior to enrollment.\n11. Uncontrolled infectious diseases or other serious illnesses, including but not limited to infections \\[e.g., human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B (HBV) or C (HCV) infection\\], congestive heart failure, unstable angina, arrhythmias, or that pose an unpredictable risk in the opinion of the attending physician.\n12. The presence of uncontrollable serous membrane fluid, such as massive pleural effusion or ascites.\n13. A history of stroke or intracranial hemorrhage within 3 months prior to enrollment.\n14. Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.\n15. Received allogeneic cell therapy within 6 weeks prior to enrollment, such as donor lymphocyte infusion.\n16. History of allergies to any of the ingredients in cell products.\n17. Conditions in which a known mental or physical illness interferes with cooperation with the requirements of the study or disrupts the results or interpretation of the results and, in the opinion of the therapeutic investigator, makes the patient unfit for study participation.\n18. There is the situation that the researcher's judgment will interfere with the whole study participation; Situations where there is significant risk to the subject; Or interferes with the interpretation of research data.\n19. Inability to understand or unwillingness to sign informed consent.\n20. Researchers believe that other reasons are not suitable for clinical trials.",{"count":566,"type":21},30,[87,24],"This is a single center, prospective, open-label, single-arm, phase 1\u002F2 study for patients with r\u002Fr B-cell NHL to evaluate the safety and efficacy of gene edited allogenic CD19 CAR-γδT cells. The cells are from healthy adult volunteer donors that are gene edited ex vivo using CRISPR-Cas9 to weaken HLA expression and further to overcome host immune system rejection (HvGR). In this study, a second generation anti-CD19 CAR prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together with intracellular 4-1BB co-stimulatory and CD3ζ signaling domains linked by a CD8α sequence comprising the hinge and transmembrane domains.\n\nA total of around 30 patients with r\u002Fr B-cell NHL will be enrolled in the study and receive allogeneic CD19 CAR-γδT cell infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of allogeneic CD19 CAR-γδT cell therapy in patients with r\u002Fr B-cell NHL.",[570],"Non Hodgkin's Lymphoma",[572,573,574],"B-cell malignancies","Relapsed or refractory","CD19 CAR-γδT",{"date":576,"type":40},"2025-08-06",{"date":578,"type":40},"2022-12-11",{"date":554,"type":21},{"name":98,"class":99},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":588,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":226},"100517171","phase-1-trac-and-power3-sppl3-genes-knock-out-allogeneic-cd19-targeting-car-t-cell-therapy-in-rr-b-nhl-100517171","NCT06014073","TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r\u002Fr B-NHL","A Phase 1\u002F2 Single-center Study Evaluating the Safety and Efficacy of TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T Cell (ATHENA) Therapy in Adults With Refractory\u002FRelapsed B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Age 18-70 (inclusive).\n2. Subjects who meet the following requirements:\n\n   2.1 Histologically confirmed refractory\u002Frelapsed B cell NHL, including the following types defined by WHO 2016:\n   * Diffuse large B-cell lymphoma (DLBCL) not otherwise specified;\n   * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL);\n   * Transformed follicular lymphoma (TFL);\n   * High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements (HGBCL);\n   * Follicular lymphoma (FL);\n   * Mantle cell lymphoma (MCL) (pathologically confirmed, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and\u002For overexpress cyclin D1);\n   * Marginal zone lymphoma (MZL), including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue (MALT) lymphoma.\n\n   2.2 Relapsed disease is defined as disease progression (PD) after achieving disease remission (including CR and PR) with the latest standard regimen.\n\n   2.3 Refractory disease is defined as no CR to first-line therapy:\n   * Evaluation of PD (never reached response or SD) after standard first-line treatment, or\n   * SD as best response after at least 4 cycles of first-line therapy (eg,4 cycles of R-CHOP), or\n   * PR as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 6 months of therapy, or\n   * Refractory post-autologous stem cell transplant (ASCT) i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy.\n\n   2.4 Individuals who are intolerant to standard treatment can also be included in the study in the investigator's judgment.\n3. Individuals must have received adequate prior therapy:\n\n   3.1 For MCL, prior therapy must have included:\n   * Anthracycline or bendamustine-containing chemotherapy and\n   * Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative) and\n   * Bruton's tyrosine kinase inhibitor (BTKi).\n\n   3.2 For other types, prior therapy must have included:\n   * Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative) and\n   * Anthracycline containing chemotherapy regimen.\n\n   3.3 For individual with transformed FL must have relapse or refractory disease after transformation to DLBCL.\n4. At least 1 measurable lesion: lymph node site with a long axis \\>1.5cm, extranodal site with a long axis \\>1.0cm (according to Lugano2014). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n5. CD19 positive (detected by immunohistochemistry \\[IHC\\]).\n6. Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for hematological toxicities and clinically non-significant toxicities such as alopecia).\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n8. Absolute neutrophil count (ANC) ≥ 1 x 10\\^9\u002FL, Platelet count ≥50 x 10\\^9\u002FL, hemoglobin (Hgb) ≥ 80g\u002FL (hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions above).\n9. Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n   9.1 Serum creatinine≤1.5 upper limit of normal (ULN) or creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL\u002Fmin.\n\n   9.2 Serum alanine aminotransferase \u002F aspartate aminotransferase (ALT\u002FAST) ≤ 3 upper limit of normal (ULN); Total bilirubin ≤ 1.5 ULN, except in subjects with 3) Gilbert's syndrome.\n\n   9.3 Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings.\n\n   9.4 Coagulation Function: International Normalized Ratio (INR) ≤ 1.5 times the upper limit of normal (ULN), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN.\n\n   9.5 Baseline oxygen saturation \\>91% on room air.\n10. Subjects of both genders who are willing to practice birth control from the time of consent through 6 months after the completion of conditioning chemotherapy. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential).\n11. Voluntarily participate in this clinical trial and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Expected survival time \\\u003C 3 months per Principal Investigator's opinion.\n2. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.\n3. Autologous stem cell transplant with therapeutic intent within 3 months of planned ATHENA CAR-T infusion.\n4. History of allogeneic stem cell transplantation.\n5. Prior CD19 targeted therapy.\n6. Patients who have used any of the following agents or treatments within a specific period of time:\n\n   6.1 Received any chemotherapy drugs or small molecule targeted drugs within 2 weeks prior to lymphodepletion;\n\n   6.2 Received any monoclonal antibodies, antibody drug conjugates (ADCs), or bispecific antibodies within 3 weeks prior to lymphodepletion;\n\n   6.3 Received radiotherapy within 6 weeks prior to lymphodepletion. However, if disease progressed at the site of radiotherapy, or if there are positive lesions detected by PET-CT at non-radiotherapy sites, enrollment is allowed.\n7. Prior CAR-T therapy or other genetically modified T cell therapy.\n8. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma.\n9. History of severe, immediate hypersensitivity reaction attributed to lymphodepletion drugs or any component of ATHENA CAR-T.\n10. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management.\n11. Uncontrolled or active infectious diseases, such as human immunodeficiency virus (HIV) infection, acute or chronic active hepatitis B or C, epstein-barr virus (EBV), and cytomegalovirus (CMV) infection.\n12. History or presence of central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n13. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement.\n14. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.\n15. Expected or possible requirement for urgent therapy within 6 weeks due to ongoing or impending oncologic emergency (eg, tumor mass effect, tumor lysis syndrome).\n16. Primary immunodeficiency.\n17. History of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n18. History of symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months of enrollment.\n19. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.\n20. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n21. Vaccine ≤ 6 weeks prior to planned start of conditioning regimen.\n22. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.","70 Years",{"count":566,"type":21},[87,24],"ATHENA chimeric antigen receptor (CAR)-T, a CD19-directed CAR-T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of relapsed or refractory (r\u002Fr) B-cell non-Hodgkin's lymphoma (NHL). The cells are from healthy adult volunteer donors that are knocked out of TRAC and Power3 (SPPL3) genes ex vivo using CRISPR-Cas9 gene editing components. In this study, a second-generation anti-CD19 CAR prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together with intracellular CD28 co-stimulatory and CD3ζ signaling domains linked by a CD28 sequence comprising the hinge and transmembrane domains.\n\nThis is a single center, prospective, open-label, single-arm, phase 1\u002F2 study. A total of around 30 patients with r\u002Fr B-cell NHL will be enrolled in the study and receive allogeneic CD19-CAR-T cell infusion. Phase 1 (n=6 to 18) is a dose escalation part, and phase 2 (n=10 to 12) is a expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of ATHENA CAR-T cell therapy in patients with r\u002Fr B-cell NHL.",[570],"2025-05-21",{"date":595,"type":40},"2025-05-25",{"date":597,"type":40},"2023-09-06",{"date":599,"type":21},"2026-09-01",{"name":98,"class":99},{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":608,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":318},"100407519","phase-2-phase-ii-clinical-trial-of-cnct19-cell-injection-in-the-treatment-of-relapsed-or-refractory-non-hodgkins-lymphoma-100407519","NCT04586478","Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Patients who are willing to sign the informed consent form;\n2. Aged 18-75 years, male or female;\n3. At screening, subjects complying with the following diagnostic and treatment requirements:\n\n   1. Complying with CD19-positive NHL according to the WHO classification 2017, which are provided specifically as follows:\n\n      * Diffuse large B cell lymphoma (DLBCL), not otherwise specified (NOS);\n      * Primary mediastinal large B cell lymphoma (PMBCL);\n      * Transformed follicular lymphoma\n      * High grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, and high grade B cell lymphoma - not otherwise specified.\n   2. Previously received≥2nd-line adequate therapy or autologous hematopoietic stem cell transplantation (ASCT), including:\n\n      * Received at least Rituximab or other CD20 targeted drugs containing (except CD20 negative tumors) chemotherapy and\n      * Received at least one chemotherapy regimen containing anthracycline;\n      * Definition of line: Stable disease (SD) after receiving a first-line adequate therapy or progressive disease (PD), and SD after a second-line therapy for at least 2 cycles or PD .\n   3. In relapsed or refractory status at screening:\n\n      * Definition of relapse: Remission (including partial remission (PR) or complete remission (CR)) after treatment with at least the standard therapy regimen (it must contain Ribuximab), and then PD;\n      * Definition of refractoriness:\n\n   Non-responsiveness to the last therapy: The best response by the last therapy is SD or PD; Relapse or progression after ASCT, including: Relapse (it must be proved by biopsy) or PD within 12 months after ASCT; if a rescue therapy is received, the patient is non-responsive (SD or PD) to the last therapy;\n\n   For transformed follicular lymphoma (TFL), patients must be treated adequately against FL, and after transformation, must have received at least once the therapy against TFL, and become relapsed or refractory after the last therapy.\n4. Measurable imaging lesion at screening: Intranodal lesion must have a long diameter of more than 1.5 cm, and extranodal lesion must have a long diameter of more than 1.0 cm (per revised IWG Response Criteria 2014 in Lymphomas);\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n6. Adequate bone marrow reserve, defined as:\n\n   * Absolute neutrophil count (ANC) \\> 1.0×109\u002FL;\n   * Absolute lymphocyte count (ALC) ≥ 0.3×109\u002FL;\n   * Platelet (PLT) ≥50×109\u002FL;\n7. Proper organ function, complying with the following criteria (except hepatic dysfunction due to tumor cell infiltration): Aspartate aminotransferase (AST) ≤ 3 Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) ≤ 3 ULN; Total serum bilirubin ≤ 2 ULN, unless there exists concurrent Gilbert syndrome; patients with Gilbert syndrome, with total serum bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN, may be included; Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula); Minimum pulmonary reserve, defined as Grade ≤ 1 dyspnea, and blood oxygen saturation \\> 91% at non-oxygen inhalation status; International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN.\n8. Vascular conditions for apheresis;\n9. Women with child-bearing potential are negative in blood\u002Furine pregnancy tests within 3 d prior to apheresis, and prior to infusion of CNCT19 cell injection infusion; any male or female patient with child-bearing potential must agree to adopt effective contraceptive measures throughout the study, and at least a year after administration of the investigational therapy. As judged by the investigator, a patient with child-bearing potential means that: He\u002Fshe has normal sexual life and is biologically fertile to have children. Non-fertile female patients (i.e., complying one of the following criteria):Previously received hysterectomy, bilateral ovariectomy, or bilateral tubal ligation, or Medically confirmed ovarian failure, or Medically confirmed postmenopause (amenorrhea of at least 12 consecutive months).\n\nExclusion Criteria:\n\n1. Patients with active central nervous system (CNS) lymphoma (a patient with CNS disease symptoms must receive lumbar puncture and MRI\u002FCT to exclude CNS lymphoma).\n2. Patients with existing central nervous system disease or with a history of central nervous system disease, e.g., epileptic seizure, cerebral ischemia\u002Fhemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellum disease, organic brain syndrome, mental disease, or any autoimmune disease involved with central nervous system.\n3. Patients receiving any of the following drugs or therapies within the specified period prior to apheresis:\n\n   * Alemtuzumab within 6 months prior to apheresis;\n   * Cladribine within 3 months prior to apheresis;\n   * Anti-CD20 monoclonal antibody within 7 d prior to apheresis;\n   * Venetoclax (BCL-2 inhibitor) within 4 d prior to apheresis;\n   * Idelalisib (PI3Kδ kinase inhibitor) within 2 d prior to apheresis;\n   * Lenalidomide within 1 d prior to apheresis;\n   * Lymphocytotoxic chemotherapy within 2 weeks prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;\n   * Non-lymphocytotoxic chemotherapy within 7 d prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;\n   * Radiotherapy within 6 weeks prior to apheresis, including big bone marrow area (e.g., sternum or pelvis) - progressive disease at radiotherapy site, or PET positive lesion at other non-radiotherapy site is eligible; if there is existing PET positive lesion in other non-radiotherapy sites, then it is allowable to conduct radiotherapy at a single lesion within 2 weeks prior to apheresis.\n4. Patients receiving chemotherapy within 2 weeks prior to CNCT19 Cell injection infusion, excluding the following conditions:\n\n   * Pretreatment chemotherapy as specified by the protocol;\n   * CNS lymphoma prophylaxis by intrathecal injection (it must be stopped within 1 week prior to infusion of CNCT19 Cell Injection).\n5. Discontinuation of a systematic therapeutic hormone within 72 h prior to infusion of CNCT19 Cell Injection; however, use of the hormone in the physiological surrogate amount is eligible (e.g., Prednisone in a dose of \\\u003C10 mg\u002Fd or equivalent).\n6. Patients previously received CAR-T cell therapy.\n7. Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n8. Patients with known active or uncontrolled synstemic autoimmune disease and under treatment.\n9. Patients complying with any of hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection.\n10. Patients who received a major surgery within 4 weeks prior to screening, and are not eligible for enrollment as judged by the investigator.\n11. Patients with concurrent active malignancy; those with a history of malignancy, cured for≥2 years, are eligible.\n12. Patients complying any of the following conditions: Left ventricular ejection fraction (LVEF) ≤45% (ECHO); New York Heart Association (NYHA) Grade III or IV congestive heart failure; Uncontrolled hypertension (systolic blood pressures≥140mmHg and\u002For diastolic blood pressures ≥90 mmHg), pulmonary hypertension, or unstable angina pectoris; Myocardial infarction or bridging or stent procedure within 12 months prior to administration of the drug; Clinically significant valvular heart disease; Other heart diseases unsuitable for enrollment, as judged by the investigator.\n13. Patients with lymphoma involved with atrium or ventricle.\n14. Patients with clinical emergency (e.g., intestinal infarction or vascular compression) requiring treatment, due to existing lymphoma body obstruction or compression at screening.\n15. Patients with active hemorrhage at screening.\n16. Patients with deep vein thrombosis within 6 months prior to screening, or a history of pulmonary embolism.\n17. Patients who are known with a history of hypersensitivity reaction to any ingredient used for the drug product in the trial.\n18. Patients vaccinated with a live vaccine within 6 weeks prior to screening.\n19. Patients with active infection at screening.\n20. Patients with a life expectancy of less than 3 months.\n21. Patients participating in any other interventional clinical study or receiving treatment of an active investigational drug within 3 half-lives prior to CNCT19 Cell Injection infusion.",{"count":504,"type":21},[24],"The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL.",[27],"2025-02-06",{"date":613,"type":40},"2025-02-07",{"date":615,"type":40},"2020-10-26",{"date":617,"type":21},"2025-09-30",{"name":619,"class":74},"Juventas Cell Therapy Ltd.",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":48},"100501195","phase-1-a-safety-tolerability-pharmacokinetics-pharmacodynamics-and-efficacy-study-of-mbs303-in-b-cell-nhl-100501195","NCT05806099","A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL","A Phase I\u002FⅡ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS303 in Patients With Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and to comply with the study protocol.\n2. Adult patients, ≥18 years of age;\n3. CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at least one prior treatment regimen with an anti-CD20 monoclonal antibody and for whom there is no available therapy expected to improve survival;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. Life expectancy ≥3 months;\n6. Measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as \\>1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as \\>1.0 cm in its longest dimension\n7. Adequate hematologic, hepatic, and renal function.\n\nExclusion Criteria:\n\n1. Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;\n2. History of central nervous system (CNS) lymphoma or other CNS disease;\n3. Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);\n4. Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;\n5. Active or suspected autoimmune diseases;\n6. Known severe allergic reaction or\u002Fand infusion reaction to monoclonal antibody;\n7. Evidence of significant, uncontrolled concomitant disease;\n8. Major surgery within 28 days prior to the first MBS303 administration or expected to undergo major surgery during the study treatment;\n9. History of another invasive malignant tumors in past 3 years;\n10. Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);\n11. Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia, or spontaneous bleeding requiring blood transfusion or other medical intervention;\n12. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);\n13. Pregnant or lactating women; Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments.",{"count":20,"type":21},[87,24],"This is a Phase I\u002FⅡ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in participants with relapsed or refractory B-cell NHL. This entry-to-human study consists of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)",[27],"2024-11-19",{"date":633,"type":40},"2024-11-20",{"date":635,"type":40},"2023-06-28",{"date":637,"type":21},"2026-11",{"name":639,"class":74},"Beijing Mabworks Biotech Co., Ltd.",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":22,"phases":649,"briefSummary":651,"conditions":652,"keywords":654,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":48},"100413339","early-phase-1-cd-70-car-t-for-patients-with-cd70-positive-malignant-hematologic-diseases-100413339","NCT04662294","CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases","Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases","Inclusion Criteria:\n\nInclusion criteria only for AML:\n\n1. Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);\n2. Relapsed or refractory CD70+ AML (meeting one of the following conditions):\n\n   1. CR not achieved after standardized chemotherapy;\n   2. CR achieved following the first induction, but CR duration is less than 12 months;\n   3. Ineffectively after first or multiple remedial treatments;\n   4. 2 or more relapses;\n3. The number of primordial cells in bone marrow is \\> 5% (by morphology), and\u002For \\> 0.01% (by flowcytometry);\n4. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol\u002FL;\n5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n7. Estimated survival time ≥ 3 months;\n8. ECOG performance status 0 to 2;\n9. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.\n\nInclusion criteria only for NHL:\n\n1. No gender and age limit;\n2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL\u002FSLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);\n3. Relapsed or refractory CD70+ NHL (meeting one of the following conditions):\n\n   1. No response or relapse after second-line or above chemotherapy regimens;\n   2. Primary drug resistance;\n   3. Relapse after auto-HSCT;\n4. At least one assessable tumor lesion per Lugano 2014 criteria\n\nInclusion criteria only for MM:\n\n1. Histologically confirmed diagnosis of CD70 multiple myeloma (MM)：\n\n   1. According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis was recurrent \u002F refractory multiple myeloma\n   2. Cases with recurrent positive minimal residual disease;\n   3. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.\n2. No gender and age limit;\n3. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n6. Estimated survival time ≥ 3 months;\n7. ECOG performance status 0 to 2;\n8. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.\n\nCommon inclusion criteria :\n\n1. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol\u002FL;\n2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n4. Estimated survival time ≥ 3 months;\n5. ECOG performance status 0 to 2;\n6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent -\n\nExclusion Criteria:\n\n1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n5. Active infection of hepatitis B virus or hepatitis C virus;\n6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;\n7. Previously treated with any CAR-T cell product or other geneticallymodified T cell therapies;\n8. Creatinine \\>2.5mg\u002Fdl, or ALT \u002F AST\\>3 times of normal amounts, or bilirubin\\>2.0 mg\u002Fdl;\n9. Other uncontrolled diseases that were not suitable for this trial;\n10. Patients with HIV infection;\n11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study. -",{"count":648,"type":21},108,[650],"EARLY_PHASE1","A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases",[653,432,145],"Acute Myeloid Leukemia",[655,656,653,657,145],"CAR T-cell therapy","CD70","Non-Hodgkin's lymphoma","2021-10-26",{"date":660,"type":40},"2021-11-04",{"date":662,"type":21},"2021-11-18",{"date":664,"type":21},"2027-01-15",{"name":666,"class":99},"Zhejiang University",{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":4,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":17,"minAge":674,"maxAge":83,"enrollmentInfo":675,"targetDuration":4,"studyType":22,"phases":677,"briefSummary":671,"conditions":678,"keywords":679,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":682,"completionDateStruct":684,"leadSponsor":686,"locationsCount":48},"100403354","early-phase-1-a-study-of-car-t-cells-therapy-for-patients-with-relapsed-andor-refractory-central-nervous-system-hematological-malignancies-100403354","NCT04532203","A Study of CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory Central Nervous System Hematological Malignancies","Clinical Trial for the Safety and Efficacy of CAR-T Cells Therapy for Patients With the Central Nervous System Involvement of Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia or B-cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Inclusion criteria only for B-ALL:\n\n  1. Male or female aged 3-70 years;\n  2. Histologically confirmed diagnosis of B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);\n  3. Relapsed or refractory CD19+ B-ALL (meeting one of the followingconditions):\n\n     1. CR not achieved after standardized chemotherapy;\n     2. CR achieved following the first induction, but CR duration isless than 12 months;\n     3. Ineffectively after first or multiple remedial treatments;\n     4. 2 or more relapses;\n  4. The number of primordial cells (lymphoblast and prolymphocyte)in bone marrow is\\>5% (by morphology), and\u002For \\>1% (by flowcytometry);\n  5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;\n* Inclusion criteria only for B-NHL:\n\n  1. Male or female aged 18-75 years;\n  2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL\u002FSLL, PMBCL, and HGBCL per the WHOClassification Criteria for Lymphoma (2016);\n  3. Relapsed or refractory B-NHL (meeting one of the followingconditions):\n\n     1. No response or relapse after second-line or abovechemotherapy regimens;\n     2. Primary drug resistance;\n     3. Relapse after auto-HSCT;\n  4. At least one assessable tumor lesion per Lugano 2014 criteria;\n* Common inclusion criteria for B-ALL and B-NHL:\n\n  1. Highly suspected or confirmed central nervous system involvement of hematological malignancies;\n  2. Total bilirubin ≤ 51 umol\u002FL, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol\u002FL;\n  3. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n  4. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n  5. Estimated survival time ≥ 3 months;\n  6. ECOG performance status 0 to 2;\n  7. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\nSubjects with any of the following exclusion criteria were not eligible for this trial:\n\n1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);\n5. Active infection of hepatitis B virus or hepatitis C virus;\n6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;\n7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;\n8. Creatinine\\>2.5mg\u002Fdl, or ALT \u002F AST \\> 3 times of normal amounts,orbilirubin\\>2.0 mg\u002Fdl;\n9. Other uncontrolled diseases that were not suitable for this trial;\n10. Patients with HIV infection;\n11. Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.","3 Years",{"count":676,"type":21},72,[650],[332,27],[332,27,655],"2020-10-22",{"date":615,"type":40},{"date":683,"type":21},"2020-11-01",{"date":685,"type":21},"2026-11-01",{"name":666,"class":99}]