[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-b-cell-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-b-cell-non-hodgkin-lymphoma":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100598618","phase-1-the-safety-tolerability-and-efficacy-of-ibr900-cell-injection-in-relapsedrefractory-b-cell-non-hodgkin-lymphoma-100598618",false,"NCT07073833","The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed\u002FRefractory B-cell Non Hodgkin Lymphoma","An Open Label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IBR900 Cell Injection in the Treatment of Relapsed\u002FRefractory CD20 Positive B-cell Non Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures;\n2. Male or female, age ≥ 18 years old;\n3. CD20 positive B-cell non Hodgkin's lymphoma (B-NHL), including but not limited to diffuse large B-cell lymphoma non-specific, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, high-grade B-cell lymphoma with MYC\u002FBCL2\u002FBCL6 rearrangements, high-grade B-cell lymphoma non-specific, primary mediastinal B-cell lymphoma, grade 3b follicular lymphoma, indolent B-cell lymphoma (mantle cell lymphoma (MCL), marginal zone B-cell lymphoma (MZL)), slow lymphocytic transformed large B-cell lymphoma with previous treatment of anthracycline containing drugs and rituximab or other CD20 targeted therapies, that meets the criteria of the 2022 WHO classification of lymphoid tissue tumors. Adequate treatment with medication. Among them, inert B-NHL must have received at least 2 lines or more of standard treatment failure, while invasive B-NHL must have received at least 1 line or more of standard treatment failure. At least one regimen contains anti-CD20 monoclonal antibody monotherapy or combination therapy; Note: Relapse is defined as disease progression after sufficient treatment to achieve remission (CR or PR), with at least one regimen containing anti-CD20; Difficult to treat is defined as disease progression (PD or SD) within 6 months after full treatment with an anti-CD20 regimen without remission, or during the treatment period\u002Fafter the end of full treatment;\n4. At least one measurable tumor lesion. Measurable lesions (2014 Lugano lymphoma efficacy evaluation criteria): longest diameter of lymph nodes\\>15mm, extranodal lesions\\>10mm; lesions that have received local treatment such as radiotherapy before, if disease progression has been proven, are considered measurable lesions;\n5. The ECOG score for physical fitness status ranges from 0 to 2 points;\n6. Female or male participants of childbearing age should agree to have no fertility plans and take effective contraceptive measures within 6 months from the signing of the ICF until the last dose of the study drug is used;\n7. Expected survival period is at least 3 months.\n\nExclusion Criteria:\n\n1. Patients with current or previous primary central nervous system lymphoma (PCNSL) or secondary central nervous system involvement. Patients with central nervous system symptoms must undergo lumbar puncture and magnetic resonance imaging (MRI) examination to exclude them;\n2. Patients who have received allogeneic hematopoietic stem cell transplantation and other organ transplantation, or who have received autologous hematopoietic stem cell transplantation within 100 days before the first dose;\n3. Receive attenuated live vaccine within 4 weeks before the first administration or plan to receive it during the study period;\n4. Patients with a history of malignant tumors within the past 5 years, except for those who have been completely cured of basal cell carcinoma of the skin or squamous cell carcinoma of the skin, melanoma in situ, and cervical carcinoma in situ, and\u002For any malignant tumor patients who have been cured without disease or have had no disease for at least 5 consecutive years;\n5. Patients with active autoimmune diseases or a history of possible recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or high-risk patients. But the following patients may be considered for inclusion if the researchers assess disease stability: autoimmune hypothyroidism that only requires hormone replacement therapy; Skin diseases that do not require systemic treatment (such as eczema, rash that accounts for less than 10% of the body surface);\n6. Patients who have undergone major surgery within 28 days prior to the first administration or are expected to undergo major surgery during the study period;\n7. Subjects who require systemic corticosteroid treatment (\\>10mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs within 7 days prior to the first administration or during the study period, but excluding topical corticosteroids via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses;\n8. Subjects with active deep vein thrombosis or pulmonary embolism within the first 6 months of screening;\n9. Patients currently suffering from interstitial lung disease or non infectious pneumonia, with active tuberculosis infection;\n10. Systemic diseases not stably controlled after treatment, such as diabetes, serious organic cardiovascular and cerebrovascular diseases;\n11. The patient's heart meets any of the following conditions: left ventricular ejection fraction (LVEF) ≤ 55%; New York Heart Association (NYHA) (see Appendix 3) Grade II or above congestive heart failure or active heart disease; Serious arrhythmias that require treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia that have been determined by the researchers to have no impact on the trial); QTc interval ≥ 450ms for males and ≥ 470ms for females (QTc formula in Appendix 4); Within 6 months prior to administration, there has been a myocardial infarction or bypass or stent surgery; Other heart diseases deemed unsuitable for inclusion by researchers;\n12. Human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) are positive during screening period, and HBV-DNA is higher than the normal range of the laboratory in the center; Patients who are positive for HCV antibodies during the screening period and have HCV-RNA levels higher than the normal range of the laboratory in their center;\n13. Evidence of uncontrollable and severe active infections during screening (such as sepsis, bacteremia, mycosis, viremia, etc.);\n14. Known subjects who have experienced severe allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, as well as any components of the investigational drug in the past (CTCAE v5.0 grade ≥ 3);\n15. Participated in clinical trials of other intervention drugs or medical devices within 4 weeks prior to the first administration of this study, or is currently undergoing treatment in other clinical trials (excluding non intervention studies);\n16. Patients with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance;\n17. Pregnant or lactating women;\n18. History of stroke or intracranial hemorrhage within 6 months;\n19. Active or documented gastrointestinal bleeding within 6 months (such as esophageal or gastric varices, ulcer bleeding);\n20. Researchers believe that patients who are not suitable to participate in the trial due to other reasons, such as rapid disease progression during the screening period.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open label clinical study: Phase Ia is a dose escalation phase, evaluating the safety, tolerability, RP2D, PK characteristics, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed\u002Frefractory B-cell non Hodgkin lymphoma (NHL); Phase Ib is the dose expansion stage, which is divided into two parts: monotherapy expansion (queue 1) and combination expansion (queue 2). The monotherapy expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed\u002Frefractory CD20 positive B-cell non Hodgkin lymphoma, while the combination expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection combined with CD20 monoclonal antibodies in the treatment of relapsed\u002Frefractory CD20 positive B-cell non Hodgkin lymphoma.",[26],"Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","RECRUITING","2026-07-01",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":31},"2025-07-01",{"date":35,"type":20},"2028-07-30",{"name":37,"class":38},"Imbioray (Hangzhou) Biomedicine Co., Ltd.","INDUSTRY",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":61},"100621901","early-phase-1-a-phase-iiia-open-label-single-center-dose-escalation-and-dose-expansion-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-imv101-as-a-single-agent-in-subjects-with-relapsedrefractory-b-cell-non-hodgkin-lymphoma-100621901","NCT07376642","A Phase I\u002FIIa, Open-label, Single-center, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IMV101 as a Single Agent in Subjects With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Aged 18 years or older, any sex.\n2. Previously histologically or cytologically confirmed relapsed\u002Frefractory B-cell non-Hodgkin's lymphoma, including the following WHO-defined types: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and mantle cell lymphoma (MCL), among others.\n3. CD19 positivity confirmed by pathology or flow cytometry analysis (subjects with prior exposure to CD19-targeted therapies must undergo repeat biopsy prior to enrollment to reconfirm CD19-positive status).\n4. Relapsed\u002Frefractory B-cell non-Hodgkin lymphoma meeting at least one of the following criteria:\n\n   1. Disease progression after at least two prior lines of systemic therapy (including relapse, treatment failure, or disease progression), with documented prior exposure to both an anti-CD20 monoclonal antibody (unless CD20-negative) and an anthracycline-based chemotherapy regimen.\n   2. Relapsed disease following autologous hematopoietic stem cell transplantation; or relapse occurring ≥2 years after allogeneic hematopoietic stem cell transplantation, in the absence of ongoing immunosuppressive therapy.\n   3. Primary refractory disease, defined as stable disease or disease progression as best response after at least two cycles of initial anti-CD20-based immunochemotherapy.\n\n      5． According to the Lugano lymphoma response criteria (Cheson et al, 2014), at least one measurable lesion must be present, meeting one of the following conditions:\n\n   \u003C!-- -->\n\n   1. A nodal lesion with a long axis \\>15 mm (short axis may be used if measurable).\n   2. An extranodal lesion with both long and short axes \\>10 mm. Lesions previously irradiated will only be considered measurable if documented progression has occurred after radiation therapy.\n\n      6． Life expectancy ≥ 12 weeks. 7． ECOG performance status score of 0 or 1. 8． Subjects must have adequate organ and marrow function. Laboratory screening must meet all of the following criteria, with all values falling within the specified ranges without ongoing supportive care. If any laboratory result is outside these limits, one repeat test is permitted within one week. If the repeat result still does not meet the criteria, the subject fails screening and is ineligible for enrollment:\n\n   \u003C!-- -->\n\n   1. Hematological criteria (in the absence of intensive transfusion \\[≥2 times within 1 week\\], platelet administration, or growth factor support \\[with the exception of recombinant erythropoietin\\] within 7 days prior to testing).\n   2. Hepatic Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤2.5×ULN, and total bilirubin ≤2×ULN (except in subjects with Gilbert's syndrome); for those with documented hepatic involvement by lymphoma, ALT and AST must be \\\u003C5×ULN.\n   3. Renal Function: Serum creatinine ≤1.5×ULN; if serum creatinine exceeds this threshold, creatinine clearance must be \\>50 mL\u002Fmin (calculated using the Cockcroft-Gault formula). Urine protein dipstick must be ≤1+; if dipstick result is ≥2+, 24-hour urine protein quantification is required (acceptable if \\\u003C1 g\u002F24h).\n\n      9． All toxicities from prior anticancer therapy must have resolved to Grade 0-1 (per NCI CTCAE v5.0) or to a level meeting the study's inclusion\u002Fexclusion criteria. Exceptions include alopecia, vitiligo, and other toxicities considered by the investigator to pose no safety risk to the subject.\n\n      10．Reproductive Status: Females of childbearing potential or male subjects with female partners of childbearing potential must be willing to use highly effective medically approved contraception from the time of informed consent until 12 months after IMV101 administration. Acceptable methods include intrauterine devices or condoms (childbearing potential includes premenopausal women and women within 24 months of menopause).\n\n      11． Subjects must provide signed and dated written informed consent. 12．Subjects must demonstrate willingness and ability to comply with the prescribed treatment plan, laboratory tests, follow-up visits, and other study requirements.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Subjects with active central nervous system (CNS) involvement or intestinal parenchymal involvement by B-cell non-Hodgkin lymphoma.\n3. Presence of lymphoma cells in cerebrospinal fluid (CSF), brain metastases, or a history of CNS lymphoma, primary CNS lymphoma, or previously detected lymphoma cells in CSF or brain metastases.\n4. Subjects with lymphoma infiltration of the atria or ventricles.\n5. Subjects who have received or require any of the following treatments\u002Ftherapies:\n\n   1. Acute or chronic graft-versus-host disease (GVHD) requiring systemic treatment within 4 weeks prior to enrollment.\n   2. Requiring immunosuppressive treatment during the study period due to autoimmune diseases (including but not limited to Crohn's disease, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, or asthma requiring bronchodilator intervention), immunodeficiency, or other medical conditions. Exceptions include type 1 diabetes; dermatological conditions not requiring systemic therapy (e.g., vitiligo, psoriasis); alopecia; hypothyroidism managed with hormone replacement therapy only; childhood asthma that has completely resolved with no intervention required in adulthood; or other conditions not expected to recur in the absence of an external trigger.\n   3. Received autologous stem cell transplantation (ASCT) within 12 weeks prior to enrollment, or any prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n   4. Administration of live attenuated vaccines within 4 weeks before the planned IMV101 administration or planned receipt of such vaccines during the 12-week study period.\n   5. Systemic corticosteroid use at a dose exceeding 15 mg\u002Fday prednisone equivalent for more than 3 days within 2 weeks prior to IMV101 administration, with the exception of inhaled corticosteroids.\n   6. Any comorbidities that, in the Investigator's judgment, are expected to require systemic corticosteroid therapy (except for physiological replacement therapy with ≤12 mg\u002Fm²\u002Fday hydrocortisone or equivalent) or other immunosuppressive agents (excluding topical therapy) within 12 weeks after IMV101 administration;\n   7. Participation in another interventional clinical trial with receipt of any investigational product within 1 month prior to the planned administration of the study drug.\n   8. Prior to IMV101 administration, subjects who have received any of the following antineoplastic therapies: chemotherapy, targeted therapy, biologic therapy, endocrine therapy, or immunotherapy, where the last dose was administered within 28 days or 5 half-lives (whichever is shorter) before the first IMV101 dose in this study; or have received traditional Chinese medicine with approved antineoplastic indications within 2 weeks prior to IMV101 administration.\n   9. Major surgery within 2 weeks prior to enrollment in this study, or planned surgery during the waiting period for IMV101 administration or within 12 weeks after treatment (excluding scheduled procedures under local anesthesia).\n6. Subjects with a history of concurrent or previous other malignancies are excluded, except for the following conditions:\n\n   1. Adequately treated basal cell or squamous cell carcinoma (requiring sufficient wound healing prior to enrollment);\n   2. Carcinoma in situ of the cervix or breast, treated with curative intent and without evidence of recurrence for at least 3 years prior to the study;\n   3. Primary tumor that has been completely resected and in complete remission for ≥5 years.\n7. Seropositivity for human immunodeficiency virus (HIV); active hepatitis B virus (HBV) infection (HBV-DNA \\>10³IU\u002FmL); acute or chronic active hepatitis C (anti-HCV positive); confirmed syphilis seropositivity; active Epstein-Barr virus (EBV) infection (IgM-positive); active cytomegalovirus (CMV) infection (IgM-positive); or SARS-CoV-2 infection confirmed by nucleic acid or antigen testing without documented resolution to negative within 7 days.\n8. Active or clinically uncontrolled severe infection; or subjects with bacterial, fungal, or viral infections requiring intravenous antibiotic therapy who, in the judgment of the Investigator, are unsuitable for study participation; or subjects on prophylactic antibiotic therapy who, in the judgment of the Investigator, may continue in the study.\n9. Uncontrolled pleural effusion, pericardial effusion, or ascites present prior to participation in this study.\n10. Oxygen saturation≤95% while on nasal cannula oxygen.\n11. Presence of other significant pulmonary diseases that may limit participation in this study, such as pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly controlled interstitial lung disease, or clinically significant abnormalities in pulmonary function tests.\n12. Known history or current presence of hepatic encephalopathy requiring treatment; subjects with current or historical central nervous system disorders, including but not limited to seizures, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune disease involving the CNS.\n13. Poorly controlled hypertension as determined by the Investigator (defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite standardized antihypertensive therapy); or hypotension requiring vasopressors; or poorly controlled diabetes despite standard treatment (fasting blood glucose ≥10.2 mmol\u002FL).\n14. History of any of the following cardiac symptoms or diseases within 6 months prior to IMV101 administration:\n\n    1. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    2. Myocardial infarction within 1 year; or unstable angina; or history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); or use of a cardiac pacemaker;\n    3. QTc interval \\> 450 ms (male) or \\> 470 ms (female) on resting electrocardiogram (ECG)\n    4. Clinically significant abnormalities on resting ECG (e.g., abnormalities in heart rate, conduction, or morphology) or complete left bundle branch block, third-degree atrioventricular block, or PR interval \\> 250 ms.\n15. History of other severe allergic reactions, such as anaphylaxis.\n16. Subjects with severe psychiatric disorders.\n17. Subjects with newly developed arrhythmias, including but not limited to those not adequately controlled by antiarrhythmic medication.\n18. History of solid organ transplantation.\n19. Subjects who, in the opinion of the Investigator, are unable or unwilling to comply with the requirements of the study protocol.\n20. Presence of any other concurrent severe and\u002For uncontrolled medical condition that, based on the Investigator's judgment, renders the subject unsuitable for study participation.",{"count":47,"type":20},30,[49],"EARLY_PHASE1","A phase I\u002FIIa, open-label, single-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and preliminary efficacy of IMV101 as a single agent in subjects with relapsed\u002Frefractory B-cell non-Hodgkin Phase I:To observe and evaluate the safety and tolerability of IMV101 in subjects with relapsed\u002Frefractory B-cell non-Hodgkin lymphoma.\n\nPhase IIa:To determine the Recommended Phase II Dose (RP2D) based on integrated safety and efficacy data following IMV101 treatment.\n\nTo evaluate the preliminary antitumor efficacy of IMV101. Secondary Study Objectives:To evaluate other safety parameters following IMV101 treatment.\n\nTo evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles following administration of IMV101.\n\nExploratory Objective:To evaluate biomarkers change pre- and post-IMV101 administration and their correlation with efficacy and safety.\n\nTo perform long-term follow-up for immunogenicity analysis, viral shedding studies, tumor multi-omics research, lentiviral integration sites, and replication-competent lentivirus (RCL), among others.",[26],"2026-03-25",{"date":54,"type":31},"2026-03-30",{"date":56,"type":31},"2025-12-29",{"date":58,"type":20},"2027-12-31",{"name":60,"class":38},"Suzhou Immunofoco Biotechnology Co., Ltd",4,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100610935","phase-1-a-clinical-study-to-explore-ct1195e-in-patients-with-relapsedrefractory-b-cell-neoplasms-100610935","NCT07234045","A Clinical Study to Explore CT1195E in Patients With Relapsed\u002FRefractory B-Cell Neoplasms","A Clinical Study to Explore the Safety, Efficacy and Cellular Metabolic Kinetics of CT1195E CAR-T Cells Injection in Patients With Relapsed\u002FRefractory B-Cell Neoplasms","Inclusion Criteria:\n\n* R\u002FR B-NHL Inclusion Criteria：\n\n  1\\. Voluntary participation in the clinical study; I fully understand and are informed of this study and sign the informed consent form; Willing to follow and able to complete all study procedures; 2. Age 18-75 years (inclusive) 3. Histologically or cytologically confirmed diagnosis of R\u002FR B-NHL according to the WHO classification of lymphoid hyperplasia and neoplasms, 5th Edition 2022, including:\n\n  1\\) Cohort A1: large B-cell lymphoma, including diffuse large B-cell lymphoma unspecified (DLBCL, NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, large B-cell lymphoma transformed from follicular lymphoma (FLBL)\u002FGrade 3b FL，transformations of indolent B-cell lymphomas; 2) Cohort A2: Mantle cell lymphoma (MCL); 3) Cohort B: follicular lymphoma grade 1-3a; 4. Prior Therapy Requirements:\n  1. Cohort A1: Patients who have previously received standard systemic therapy, including regimens containing anti-CD20 drugs (except CD20 negative) and anthracyclines;\n  2. Cohort A2: Prior standard systemic therapy, including an anti-CD20 agent (except CD20 negative) , anthracycline or bendamustine-containing regimen, and a BTK inhibitor;\n  3. Cohort B: previously received standard systemic therapy, including regimens containing anti-CD20 drugs (except CD20 negative) regimen; 5. Intolerance during the last treatment, or the need for new treatment after the last adequate treatment as assessed by the investigator; 6. At least one of the following:\n\n  1\\) As measured by CT: Nodal lesions \\> 1.5 cm in long diameter or extranodal lesions \\> 1.0 cm in long diameter and measurable in short axis; 2) As measured by PET: FDG uptake fraction of 4 or 5; 7. Estimated survival \\> 12 weeks; 8. Eastern Cooperative Oncology Group (ECOG) score 0-1; 9. Participants should meet the following test results (there should be no ongoing supportive care):\n  1. Hematology: ① Platelet (PLT) ≥ 75 × 109\u002FL (study participants with bone marrow or peripheral blood involvement: PLT ≥ 50 × 109\u002FL), ② Hemoglobin (Hb) ≥ 80 g\u002FL (study participants with bone marrow or peripheral blood involvement: Hb ≥ 60 g\u002FL);\n  2. Endogenous creatinine clearance ≥ 50 mL\u002Fmin, or creatinine ≤ 1.5 × ULN (using Cockcroft-Gault formula);\n  3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; If lymphoma invades the liver: AST and ALT ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;\n  4. International normalized ratio (INR) and activated partial thromboplastin time (APTT) were required to be ≤ 1.5 × ULN.\n  5. Oxygen saturation ≥ 92% in non-oxygen inhalation state;\n  6. Left ventricular ejection fraction (LVEF) ≥ 50% (LVEF value near the cut-off value can be enrolled after adequate risk assessment by the investigator); 10. Female participants of child-bearing potential must have a negative pregnancy test at the time of screening and before receiving lymphodepletion therapy, be willing to use a highly effective and reliable method of contraception within 1 year after receiving study treatment, and absolutely prohibit egg donation within 1 year after receiving study treatment infusion during the study; A male participant, if sexually active with a female of childbearing potential, is willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment. All male participants absolutely refrain from donating sperm for 1 year after receiving study treatment infusion during the study.\n* R\u002FR B-ALL Inclusion Criteria\n\n  1. Voluntary participation in the clinical study; I fully understand and are informed of this study and sign the informed consent form; Willing to follow and able to complete all study procedures;\n  2. Age 18-75 years (inclusive);\n  3. Morphologically, immunologically, or molecularly confirmed diagnosis of R\u002FR B-ALL (Cohort C) and 1 of the following criteria is met:\n\n  \u003C!-- -->\n\n  1. Patients who did not achieve complete remission after standard induction regimen chemotherapy or had early relapse after complete remission (\\\u003C 12 months) or late relapse after complete remission (≥ 12 months) and did not achieve complete remission after standard one course of induction regimen chemotherapy and relapsed after 2 or more CR or CRi;\n  2. For Ph + ALL patients who have not achieved complete remission after receiving at least one TKI treatment in addition to standard induction chemotherapy, or relapsed after complete remission (those who cannot tolerate TKI treatment or have contraindications for TKI treatment, or have T315I mutation are not required to receive TKI treatment); 4. Leukemia cells with positive expression of CD19 and\u002For CD20 in bone marrow or peripheral blood; 5. Bone marrow cell morphology or peripheral blood indicates blast ratio ≥ 5%; 6. Estimated survival \\> 12 weeks; 7. Eastern Cooperative Oncology Group (ECOG) score 0-2; 8. Participants should meet the following test results (there should be no ongoing supportive care):\n\n  \u003C!-- -->\n\n  1. Endogenous creatinine clearance ≥ 50 mL\u002Fmin, or creatinine ≤ 1.5 × ULN (using the Cockcroft-Gault formula);\n  2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; If hepatobiliary involvement: AST and ALT ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;\n  3. International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN;\n  4. Oxygen saturation ≥ 92% in non-oxygen inhalation state;\n  5. Left ventricular ejection fraction (LVEF) ≥ 50% (LVEF values near the cut-off value may be enrolled after adequate risk assessment by the investigator).\n\n  9\\. Female participants of child-bearing potential must have a negative pregnancy test at the time of screening and before receiving lymphodepletion therapy, be willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment, and absolutely refrain from egg donation for 1 year after receiving study treatment infusion during the study; A male participant, if sexually active with a female of childbearing potential, is willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment. All male participants absolutely refrain from donating sperm for 1 year after receiving study treatment infusion during the study.\n\nExclusion Criteria:\n\n* R\u002FR B-NHL Exclusion Criteria：\n\n  1. Pregnant or lactating females;\n  2. Study participants with a history of neurological disease, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disorders or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis;\n  3. Presence of HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);\n  4. Current presence of any uncontrolled active infection, including but not limited to active tuberculosis study participants (as judged by the investigator);\n  5. Known or suspected long-term active EBV infection, known history of HLH;\n  6. The toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE 5.0) ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator;\n  7. Received autologous stem cell transplantation within 12 weeks before signing the informed consent form; Received allogeneic stem cell transplantation;\n  8. Prior treatment targeting CD19 (unless the CD19 or CD20 target remains positive);\n  9. Antineoplastic therapy, including but not limited to cytotoxic therapy, monoclonal antibodies or antibody conjugates, targeted therapy, radiotherapy, epigenetic therapy, or investigational drug therapy, or use of an invasive investigational medical device within 14 days or 5 half-lives (whichever is shorter) prior to cell infusion. Participants are eligible for the study regardless of the end date of radiotherapy if the radiation field covers ≤ 5% bone marrow reserve;\n  10. Systemic corticosteroids equivalent to \\> 15 mg\u002Fday prednisone within 7 days prior to informed consent, with the exception of topical corticosteroids;\n  11. Vaccination with live attenuated vaccines, inactivated vaccines or RNA vaccines within 4 weeks prior to signing the informed consent form;\n  12. Allergy or intolerance to CLD drugs, tocilizumab, or allergy to the components of CT1195E cell infusion preparation (dimethyl sulfoxide\u002FDMSO); Or previous history of other severe allergies such as anaphylactic shock;\n  13. Study participants with any of the following cardiac conditions:\n\n  \u003C!-- -->\n\n  1. New York Heart Association (NYHA) Class III or IV heart failure;\n  2. Myocardial infarction, coronary artery bypass grafting, or unstable angina 6 months prior to screening;\n  3. History of clinically significant uncontrolled arrhythmia, such as ventricular arrhythmia;\n  4. History of severe non-ischemic cardiomyopathy;\n  5. Other cardiac disease that, in the opinion of the investigator, may jeopardize the health of the study participant due to participation in this clinical study; 14. Have other severe pulmonary disease that may endanger the life of the study participant as judged by the investigator; 15. Have a second primary malignancy requiring treatment or not in complete remission within the past 2 years, with the exception of successfully treated non-metastatic basal cell or squamous cell skin cancer, non-metastatic carcinoma in situ of the prostate, breast or cervical cancer, non-muscle invasive bladder cancer or thyroid cancer and other low-grade tumors; 16. Major surgery within 2 weeks before signing the informed consent form, or planning to undergo major surgery during the study or within 4 weeks after the administration of study treatment (excluding cataract and other surgery under local anesthesia); 17. Inability or unwillingness of the participant to comply with the requirements of the study protocol as assessed by the investigator, or for other reasons unsuitable for participation in this clinical study.\n* R\u002FR B-ALL Exclusion Criteria：\n\n  1. Pregnant or lactating females;\n  2. Study participants with a history of neurological disorders, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disorders or any disease involving the central nervous system, or active central nervous system (CNS) leukemia;\n  3. Presence of HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);\n  4. Current presence of any uncontrolled active infection, including but not limited to active tuberculosis study participants (as judged by the investigator);\n  5. Known or suspected long-term active EBV infection, known history of HLH;\n  6. The toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE V5.0) ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator;\n  7. Study participants with solitary extramedullary lesions; Study participants with genetic syndromes associated with bone marrow failure states: such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.\n  8. Study participants who relapsed after treatment with drugs targeting CD19 and\u002For CD20 prior to screening and who are judged not to benefit by the investigator;\n  9. Received autologous or allogeneic stem cell transplantation within 3 months before signing the informed consent form; Donor lymphocyte infusion (DLI) within 6 weeks;\n  10. Active graft-versus-host disease (GVHD) of grade 2-4 within 4 weeks before signing the informed consent form;\n  11. Antineoplastic therapy, including but not limited to cytotoxic therapy, monoclonal antibodies or antibody conjugates, targeted therapy, radiotherapy, epigenetic therapy, or investigational drug therapy, or use of an invasive investigational medical device within 14 days or 5 half-lives (whichever is shorter) prior to cell infusion. Participants are eligible for the study regardless of the end date of radiotherapy if the radiation field covers ≤ 5% bone marrow reserve;\n  12. Systemic corticosteroids equivalent to \\> 15 mg\u002Fday prednisone within 3 days prior to cell infusion, except for topical corticosteroids;\n  13. Vaccination with live attenuated vaccines, inactivated vaccines or RNA vaccines within 4 weeks prior to signing the informed consent form;\n  14. Allergy or intolerance to CLD drugs, tocilizumab, or allergy to the components of CT1195E cell infusion preparation (dimethyl sulfoxide\u002FDMSO); Or previous history of other severe allergies such as anaphylactic shock;\n  15. Study participants with any of the following cardiac conditions:\n\n  \u003C!-- -->\n\n  1. New York Heart Association (NYHA) Class III or IV heart failure;\n  2. Myocardial infarction, coronary artery bypass grafting, or unstable angina 6 months prior to screening;\n  3. History of clinically significant uncontrolled arrhythmia, such as ventricular arrhythmia;\n  4. History of severe non-ischemic cardiomyopathy;\n  5. Other cardiac disease that, in the opinion of the investigator, may jeopardize the health of the study participant due to participation in this clinical study; 16. Have other severe pulmonary disease that may endanger the life of the study participant as judged by the investigator; 17. Have a second primary malignancy requiring treatment or not in complete remission within the past 2 years, with the exception of successfully treated non-metastatic basal cell or squamous cell skin cancer, non-metastatic carcinoma in situ of the prostate, breast or cervical cancer, non-muscle invasive bladder cancer or thyroid cancer and other low-grade tumors; 18. Major surgery within 2 weeks before signing the informed consent form, or planning to undergo major surgery during the study or within 4 weeks after the administration of study treatment (excluding cataract and other surgery under local anesthesia); 19. After organ transplantation; 20. Inability or unwillingness of the participant to comply with the requirements of the study protocol as assessed by the investigator, or for other reasons unsuitable for participation in this clinical study.","75 Years",{"count":47,"type":20},[23],"A Clinical Study to Explore the Safety, Efficacy and Cellular Metabolic Kinetics of CT1195E CAR-T Cells Injection in Patients with Relapsed\u002FRefractory B-Cell Neoplasms",[26,74],"Relapsed\u002FRefractory B-cell ALL",[76],"CT1195E","NOT_YET_RECRUITING","2025-11-14",{"date":80,"type":31},"2025-11-18",{"date":82,"type":20},"2025-11-30",{"date":84,"type":20},"2028-06-30",{"name":86,"class":87},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,"Relapsed\u002FRefractory B-Cell Non-Hodgkin Lymphoma"]