[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing IASO Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":243},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,48,76,101,127,149,172,197,222],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100632162","phase-1-eque-cel-for-the-treatment-of-patients-with-relapsedrefractory-multiple-myeloma-100632162",false,"NCT07510100","Eque-cel for the Treatment of Patients With Relapsed\u002FRefractory Multiple Myeloma","A Phase I\u002FII Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) for the Treatment of Patients With Relapsed\u002FRefractory Multiple Myeloma","FUMANBA-04","* Inclusion Criteria\n* 1\\. Aged 18 to 70 years, male or female.\n* 2\\. Patients with a confirmed diagnosis of relapsed\u002Frefractory multiple myeloma according to the IMWG diagnostic criteria.\n* 3\\. Patients who have received at least three prior treatment regimens (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibody-based chemotherapy regimens) and have documented disease progression during or within 12 months of their most recent anti-myeloma treatment.\n* 4\\. Patients with measurable disease at screening, as determined by any of the following criteria:\n* Serum M-protein level: IgG type M-protein level ≥ 10 g\u002FL, IgA, IgD, IgE, IgM type M-protein level ≥ 5 g\u002FL\n* Urinary M-protein level ≥ 200 mg\u002F24 hours\n* 5\\. Light-chain multiple myeloma without measurable M protein in serum or urine: involved serum free light chain ≥ 100 mg\u002FL with an abnormal serum κ\u002Fλ free light chain ratio. ECOG PS 0 or 1.\n* 6\\. Patients must have adequate organ function and meet all of the following pre-enrollment laboratory test results:\n\nHematological Tests:\n\n* Absolute Neutrophil Count (ANC) ≥ 1×109\u002FL (Supportive growth factors are permitted, but supportive treatment must not have been administered within 7 days prior to the laboratory test)\n* Absolute Lymphocyte Count (ALC) ≥ 0.3×109\u002FL\n* Platelet Count ≥ 50×109\u002FL (Supportive transfusions must not have been administered within 7 days prior to the laboratory test)\n* Hemoglobin ≥ 60 g\u002FL (Red blood cell \\[RBC\\] transfusions must not have been administered within 7 days prior to the laboratory test, but recombinant human erythropoietin is permitted)\n\nLiver Function:\n\n* ALT and AST ≤ 2.5×upper limit of normal (ULN)\n* Serum Total Bilirubin ≤ 1.5 x ULN Renal Function: Creatinine clearance (CrCl) calculated using the Cockcroft-Gault formula ≥ 40 mL\u002Fmin CrCl = (140 - age) × weight (kg) × \\[0.85 for women\\] \u002F 72 × \\[ serum creatinine (mg\u002FdL)\\]\n\nCoagulation function:\n\n* Fibrinogen ≥ 1.0 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤ 1.5× ULN\n* Prothrombin time (PT) ≤ 1.5× ULN Corrected serum calcium ≤11 mg\u002FdL Oxygen saturation \\> 91% Left ventricular ejection fraction (LVEF) ≥ 50%.\n* 7\\. Female patients of childbearing potential or male patients with partners of childbearing potential agree to use effective contraception (safe-day contraception not included) throughout the study period from screening through one year after Eque-cel infusion.\n\n\"Effective contraceptive methods\" specifically refers to: User-independent methods: 1) Intrauterine devices, intrauterine hormone-releasing systems; 2) Partner has undergone vasectomy.\n\nUser-dependent methods: 1) Combined hormonal contraception (containing estrogen and progestin) with ovulation suppression:\n\nOral; 2) Progestin-only hormonal contraception with ovulation suppression ( oral).\n\n-8. Prior to screening, subjects must manually sign an Institutional Review Board-approved ICF.\n\nExclusion Criteria\n\n* 1\\. Patients with graft-versus-host disease (GVHD) or requiring long-term use of immunosuppressants.\n* 2\\. Patients with a history of BCMA-targeted therapy.\n* 3\\. Patients who have undergone autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks prior to apheresis, two auto-HSCTs, or prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n* 4\\. Patients who have received prior anti-myeloma therapy, including:\n* Monoclonal antibody therapy within 21 days prior to apheresis.\n* Cytotoxic chemotherapy or proteasome inhibitor therapy within 14 days prior to apheresis.\n* Immunomodulatory therapy within 7 days prior to apheresis.\n* Other anti-myeloma therapy within 14 days or within 5 half-lives (whichever is longer) prior to apheresis.\n* 5\\. Use of systemic corticosteroids at a therapeutic dose (defined as \\>20 mg\u002Fday of prednisone or equivalent) within 7 days prior to apheresis.\n\nPhysiological replacement steroids, topical steroids, and inhaled steroids are permitted.\n\n* 6\\. Patients with uncontrolled hypertension despite medical therapy.\n* 7\\. Severe cardiac disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] grade ≥ III), and severe arrhythmia.\n* 8\\. Unstable systemic disease as determined by the investigator, including but not limited to severe liver, renal, or metabolic disease requiring treatment.\n* 9\\. Patients with malignancies other than multiple myeloma (MM) within 5 years prior to screening.\n\nexcluding adequately treated cervical epithelial cell adenocarcinoma, basal cell carcinoma or squamous cell skin cancer, localized prostate cancer after curative surgery, and ductal carcinoma in situ after curative surgery.\n\n* 10\\. Patients with a history of solid organ transplantation.\n* 11\\. Patients with suspected or confirmed central nervous system infiltration by plasma cell neoplasms.\n* 12\\. Multiple myeloma patients with extramedullary lesions (excluding those with only paraskeletal extramedullary lesions where the single largest transverse diameter is ≤3cm).\n* 13\\. Multiple myeloma patients with concomitant plasma cell leukemia (peripheral blood plasma cell count ≥5%).\n* 14\\. Major surgery within 2 weeks prior to apheresis or planned surgery within 2 weeks after study treatment (subjects scheduled for local anesthesia surgery may participate in this study).\n* 15\\. Received investigational drugs from other interventional clinical trials within 1 month prior to signing the Informed Consent Form (ICF).\n* 16\\. Patients with an uncontrolled active infection (excluding CTCAE Grade 2 urinary tract infection or respiratory infection) within 7 days prior to apheresis.\n* 17\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with detectable hepatitis B virus (HBV) DNA in peripheral blood; Hepatitis C virus (HCV) positive with hepatitis C virus (HCV) RNA positive in peripheral blood; Human Immunodeficiency Virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA test positive; Syphilis test positive.\n* 18\\. Pregnant or lactating women.\n* 19\\. Patients with psychiatric disorders, impaired consciousness, or central nervous system disease.\n* 20\\. Patients whose non-hematologic toxicities from previous antimyeloma therapy have not resolved to baseline or Grade ≤ 1 (NCI-CTCAE v5.0) (excluding alopecia and Grade 2 peripheral neuropathy).\n* 21\\. Other conditions deemed ineligible for enrollment by the investigator.","ALL","18 Years","70 Years",{"count":21,"type":22},17,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study is a single-armed, open-label, multicenter Phase 1\u002F2 study to evaluate the efficacy and safety of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) in subjects with relapsed and refractory Multiple Myeloma.",[29],"Relapsed\u002FRefractory Multiple Myeloma",[31,32,33,34],"Relapsed\u002FRefractory","Multiple Myeloma","BCMA","CAR-T","NOT_YET_RECRUITING","2026-03-27",{"date":38,"type":39},"2026-04-03","ACTUAL",{"date":41,"type":22},"2026-05-10",{"date":43,"type":22},"2030-01-31",{"name":45,"class":46},"Nanjing IASO Biotechnology Co., Ltd.","INDUSTRY",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100601399","phase-1-ub-vv410-in-subjects-with-active-refractory-systemic-lupus-erythematosus-or-lupus-nephritis-100601399","NCT07109986","UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis","An Open-Label Clinical Study of UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤65 at time of consent.\n2. Provide voluntary written informed consent.\n3. Documented medical records indicated SLE diagnosis or diagnosis of SLE according to the 2019 EULAR（European Alliance of Associations for Rheumatology）\u002FACR（American College of Rheumatology） classification criteria for SLE for at least 6 months.\n4. Current or history of elevated anti-dsDNA（anti-double-stranded DNA ） and\u002For elevated anti-Smith antibody.\n5. Alanine aminotransferase (ALT) ≤ 2.5 × ULN（upper limit of normal）, aspartate aminotransferase (AST) ≤ 2.5 × ULN, AND total bilirubin \\\u003C 1.5 × ULN (or AST, ALT, and alkaline phosphatase \\\u003C 5 × ULN, and total bilirubin ≤ 3 × ULN for subjects with Gilbert's syndrome\n6. No ongoing coagulopathies requiring periodic replacement of clotting factors (eg, fresh frozen plasma, cryoprecipitate). Note: Subjects on a stable anticoagulant regimen \\> 6 months with activated partial thromboplastin time (APTT) ≤ 2.5 × ULN and international normalized ratio (INR) \\> 2 and \\\u003C 3 are allowed on study.\n7. No serious concomitant diseases or active\u002Funcontrolled infections.\n8. For LN-specific subjects: Active, biopsy-proven, proliferative LN with the classification of Class III or Class IV according to the 2018 revised ISN\u002FRPS criteria. Note: Overlapping Class V is allowed.\n9. For Non-LN SLE-specific subjects: SLEDAI-2K（Systemic Lupus Erythematosus Disease Activity Index 2000） score of ≥ 8 (including at least 4 points from non-laboratory assessments; ) and at least 2 BILAG（British Isles Lupus Assessment Group） B organ system scores, and\u002For at least 1 BILAG A organ system score, including, but not limited to, cardiac (peri- or myocarditis), respiratory (pleuritis or lung involvement), vascular, hematological and musculoskeletal.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding.\n2. BILAG A for neuropsychiatric SLE.\n3. Any acute, severe lupus-related flare that needs immediate treatment, such as acute pericarditis, catastrophic antiphospholipid syndrome, or acute CNS lupus (eg, psychosis, seizure).\n4. Diagnosis of drug-induced SLE rather than idiopathic SLE.\n5. Receiving hemodialysis or peritoneal dialysis.\n6. History of previous bone marrow transplantation, gene therapy, adoptive cell transfer, or any kind of CAR T-cell therapy.\n7. History of or active human immunodeficiency virus (HIV) infection.\n8. Active hepatitis B (HepB) or hepatitis C (HepC). Note: Subjects with negative HepB virus DNA or a negative HepC virus RNA assay for viral load quantifications are permitted. Additionally, subjects who are positive for HepB surface antigen and\u002For anti-HepB core antibody with a negative HepB virus DNA are eligible.\n9. Allergies to supportive medications required for CAR T-cell toxicity management (eg, tocilizumab).\n10. Ongoing CNS diseases (eg, seizure disorder, tremor, history of cerebral vascular accident \\[CVA\\]\u002Frecurrent transient ischemic attack \\[TIA\\], cerebritis, substantial psychiatric disorder) that would preclude evaluation of immune effector cell-associated neurotoxicity syndrome (ICANS).\n11. Serious and\u002For uncontrolled medical condition that, in the Investigator's judgment, would cause an unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol.\n12. Major surgery within 12 weeks prior to administration of UB-VV410 or plans to undergo major surgery during the trial period and whom the Investigator considers to be at unacceptable risk.\n13. Actively receiving treatment in other interventional clinical trials. Note: continued follow-up on previous trials is allowed for survivorship, but no further investigational agents or assessments will be allowed.","65 Years",{"count":57,"type":22},21,[25],"This is an open-label investigator-initiated trial (IIT) to assess the safety, efficacy, and PK（pharmacokinetic）\u002FPD（pharmacodynamics ） of UB-VV410 in adult subjects with clinically active treatment-refractory SLE. The study population will include subjects with active LN (as defined by evidence of active inflammation on renal biopsy, referred to as the LN cohort) and subjects with active SLE without LN (ie, non-LN SLE, referred to as the non-LN cohort). It is expected that the safety profile of UB-VV410 will be similar in subjects with active LN and subjects with active non-LN SLE; thus, dose finding (DF) will be conducted in the 2 subpopulation cohorts combined. Dose expansion (DE) may be conducted separately in the LN and non-LN cohorts to characterize the preliminary efficacy of UB-VV410, as well as its safety and PK\u002FPD, in each subpopulation.\n\nThe objective of this study is to determine the MTD（maximum tolerated dose）\u002FMAD（maximum administered dose） and the recommended dose for subsequent studies of UB-VV410 in subjects with active LN and in subjects with active non-LN SLE. The DF portion will evaluate the safety profile of UB-VV410 administered at various DLs（dose levels）. The DE portion will further optimize the dose and define the safety profile and preliminary efficacy of UB VV410. The study will use the Bayesian optimal interval (BOIN) design to allocate subjects to various DLs to minimize exposure to subtherapeutic DLs while maintaining appropriate safety parameters. DF will be initiated with UB-VV410 administered IV and starting at DL1.\n\nDuring DF, additional subjects may be backfilled at DLs found to be safe per the BOIN design and with promising activity. After DF of UB-VV410 has been completed, DE with up to 14 subjects per DL within each subpopulation cohort (eg, LN and non-LN cohorts) may be implemented at DLs less than or equal to the MTD\u002FMAD and demonstrating efficacy to further characterize the toxicity, tolerability, PK\u002FPD, and preliminary efficacy of UB-VV410 at the selected DLs. The DE portion will further characterize product safety and preliminary efficacy in order to optimize benefit\u002Frisk. The number of DLs for DE will be determined based on the safety, activity and PK\u002FPD data observed from DF.\n\nIn addition, some subjects may receive retreatment with UB-VV410 if there are preliminary findings suggesting incomplete improvement and acceptable safety.",[61,62],"Systemic Lupus Erythematosus","Lupus Nephritis",[64,62,61,65],"UB-VV410","IASO","RECRUITING","2026-01-21",{"date":69,"type":39},"2026-01-23",{"date":71,"type":39},"2025-10-27",{"date":73,"type":22},"2030-07-08",{"name":45,"class":46},1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100573224","phase-1-ub-vv400-in-combination-with-rapamycin-in-relapsed-or-refractory-b-cell-malignancies-100573224","NCT06743503","UB-VV400 in Combination With Rapamycin in Relapsed or Refractory B-cell Malignancies","An Exploratory, Open-label Study of UB-VV400 in Combination With Rapamycin in Relapsed or Refractory B-cell Malignancies","Inclusion Criteria:\n\n1. Age ≥ 18 at time of consent.\n2. Provide voluntary written informed consent.\n3. Relapsed\u002Frefractory disease for subjects that are either CAR T-naive or CAR T-exposed.\n4. Measurable disease according to Lugano 2014 criteria.\n5. No serious concomitant diseases or active\u002Funcontrolled infections.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 40%.\n8. Pulmonary function: pulse oximetry ≥ 90% on room air at rest.\n9. Renal function: serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) or creatinine clearance ≥ 45 mL\u002Fmin.\n10. Absolute lymphocyte count (ALC) ≥ 0.2×10\\^9\u002FL.\n11. Alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, AND total bilirubin \\\u003C 1.5 × ULN.\n12. No ongoing coagulopathies requiring periodic replacement of clotting factors (eg, fresh frozen plasma, cryoprecipitate).\n13. Women of childbearing potential must:\n\n    1. Have 2 negative pregnancy tests verified (one negative serum beta human chorionic gonadotropin \\[β-hCG\\] at screening and another within 48 hours prior to treatment withUB-VV400).\n    2. Commit to \"true abstinence\" from heterosexual intercourse or agree to use and complywith highly effective, uninterrupted contraception for 12 months after administration of UB-VV400 .\n    3. Abstain from breastfeeding for 12 months following administration of UB-VV400.\n14. Men with partners of childbearing potential must commit to \"true abstinence\" from heterosexual intercourse or agree to use a highly effective form of contraception duringheterosexual contact with a pregnant individual or any individual of childbearing potential for 12 months after administration of UB-VV400, regardless of past vasectomy.\n15. Subjects must agree not to donate blood, organs, sperm\u002Fsemen, and\u002For egg cells for use for at least 1 year following treatment with UB-VV400 alone or in combination with rapamycin. Insufficient data are available to define a duration of time sufficient to make a recommendation on when it is safe to donate any tissue; therefore, subjects should not donate any tissue after administration of UB-VV400.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding.\n2. Subjects with current isolated central nervous system (CNS) tumor involvement.\n3. Subjects with a prior malignancy whose clinical course or management has the potential to interfere with the safety and\u002For efficacy evaluation of the clinical trial.\n4. Prior treatment with any of the following: allogeneic bone marrow transplantation, gene therapy, or adoptive cell transfer of any kind except for CAR T-cell therapy.\n5. Treatment with prior CD22-directed therapy except for UB-VV400.\n6. History of or active human immunodeficiency virus (HIV).\n7. Active hepatitis B (HepB) or hepatitis C (HepC).\n8. For subjects receiving rapamycin: a. History of angioedema; b. Pneumonitis (Grade 3 or greater).\n9. Ongoing Grade \\> 2 toxicities from the last line of anticancer therapy.\n10. Use of the following:\n\n    1. Therapeutic systemic doses of corticosteroids (defined as \\> 20 mg prednisone equivalent) within 72 hours before dosing with UB-VV400.\n    2. Approved targeted therapies:\n\n    i. Small molecules: within 3 half-lives before dosing with UB-VV400 (see package insert). ii. Antibodies: within 14 days before dosing with UB-VV400. iii. CAR T therapy: within 28 days before dosing with UB-VV400. c. Autologous stem cell transplant within 28 days before dosing with UB-VV400. d. Cytotoxic chemotherapy (eg, alkylators, anthracyclines) within 14 days before dosing with UB-VV400.\n\n    e. Any experimental agent (ie, not approved for disease\u002Findication or with accepted consensus guidelines recommendation) within 4 weeks before dosing with UB-VV400 unless progression has been documented and a minimum of 3 half-lives has elapsed.\n\n    f. Any immune-suppressing agent within 28 days before dosing with UB-VV400 (eg, tacrolimus, mycophenolate mofetil, immunosuppressive antibodies such as anti-tumor necrosis factor \\[TNF\\]\u002FIL-6).\n\n    g. Radiation within 4 weeks before dosing with UB-VV400 (palliative radiation to a symptomatic lesion\\[s\\] is allowed if at least one additional, non-irradiated, measurable lesion remains present to assess response).\n\n    h. Prophylactic treatment with short-acting oral antiretroviral medications within 7 days before UB-VV400 administration. Long-acting antiretroviral prophylaxis is not allowed within 2 years of UB-VV400 treatment.\n11. Allergies to rapamycin or supportive medications required for CAR T-cell toxicity management (eg, tocilizumab).\n12. Systemic autoimmune diseases or immunodeficiency diseases (except for well-controlled type I diabetes with hemoglobin A1C \\[HbA1c\\] less than 8% or well-controlled thyroid disease, as assessed by the treating physician).\n13. Ongoing CNS diseases (eg, seizure disorder, tremor, history of cerebral vascular accident \\[CVA\\]\u002Frecurrent transient ischemic attack \\[TIA\\]) that would preclude evaluation of immune effector cell-associated neurotoxicity syndrome (ICANS).\n14. Presence of uncontrolled angina or other acute uncontrolled heart disease. Myocardial infarction within the previous 6 months. New York Heart Association (NYHA) Class III or IV. History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n15. Actively receiving treatment in other interventional clinical trials. Note: continued follow-up on previous trials is allowed for survivorship, but no further investigational agents or assessments will be allowed.",{"count":84,"type":22},70,[25],"This is an exploratory, open-label, investigator-initiated trial (IIT) of the safety, efficacy, and PK\u002FPd of UB-VV400 alone and in combination with rapamycin in adult subjects with R\u002FR LBCL. LBCL will include subjects with aggressive lymphoma, defined as diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), including high-grade lymphoma (HGL) with double\u002Ftriple hit DLBCL; transformed DLBCL (tDLBCL), including Richter's transformation; follicular lymphoma Grade 3B (FL3B); and primary mediastinal B-cell lymphoma (PMBCL). The study will include subjects who have had prior CD19-directed CAR T-cell exposure and subjects who are CAR T cell-naive. Clinical unmet need exists in both populations.\n\nThe objective of this study is to determine the MTD\u002FMAD and following study of UB-VV400 administered alone and in combination with rapamycin. The dose-finding (DF) portion will evaluate the safety profile of UB-VV400 administered at various dose levels (DLs) alone (Stage 1) and in combination with rapamycin (Stage 2).\n\nThe dose-expansion (DE) portion will further optimize the dose and define the safety profile and preliminary efficacy of UB-VV400 alone and\u002For in combination with rapamycin. The study will use the Bayesian optimal interval (BOIN) design to allocate subjects to various DLs to minimize exposure to subtherapeutic DLs while maintaining appropriate safety parameters. DF will consist of 2 stages: Stage 1 DF aims to identify the MTD of UB-VV400 monotherapy, and Stage 2 DF aims to identify the MTD of UB-VV400 in combination with rapamycin. DF will be initiated in Stage 1 with UB-VV400 monotherapy, administered IV and starting at DL1.",[88],"Large B-cell Lymphoma",[90,91,88],"UB-VV400","relapsed or refractory","2025-09-12",{"date":94,"type":39},"2025-09-18",{"date":96,"type":39},"2025-04-11",{"date":98,"type":22},"2030-07-31",{"name":45,"class":46},2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100551815","phase-3-a-phase-iii-study-of-eque-cel-in-subjects-with-len-refractory-rrmm-fumanba-03-100551815","NCT06464991","A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)","A Phase III Randomized, Controlled Study of Equecabtagene Autoleucel Injection in Subjects With Lenalidomide-Refractory R\u002FR Multiple Myeloma","FUMANBA-03","Inclusion Criteria:\n\n1. 18 to 75 years of age (inclusive of critical values), either gender.\n2. The subject was previously diagnosed with multiple myeloma and had received 1-2 lines of therapy (including chemotherapy regimens based on proteasome inhibitors and immunomodulatory agents, with each line of therapy receiving at least 1 full cycle ; Documented disease progression during or within 12 months after the most recent anti-myeloma therapy.\n3. Subjects was lenalidomide-refractory during prior therapy.\n4. ECOG score of 0 or 1.\n5. Subjects must have appropriate organ function and meet all of the following laboratory test results before enrollment:\n\n(1) Haematology: absolute neutrophil count (ANC) ≥1×10\\^9\u002FL (support with growth factor is allowed, but must not have received supportive treatment within 7 days before the laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10\\^9\u002FL; Platelets ≥50×10\\^9 \u002F L (must not have received platelet transfusion within 7 days prior to laboratory test); Hemoglobin ≥60g\u002FL (must not have received red blood cells transfusion within 7 days prior to laboratory test); (2) Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times of upper limit of normal (ULN); Serum total bilirubin ≤1.5 times of ULN; (3) Renal function: creatinine clearance (CrCl) calculated by Cockcroft-Gault formula ≥ 40 ml\u002Fmin; (4) Coagulation: fibrinogen≥1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, pro-thrombin time (PT) ≤ 1.5 × ULN; (5) Pulse oxygen saturation \\> 91%; (6) Left ventricular ejection fraction (LVEF)≥50%;\n\n6\\. Subjects agree to use effective tools or drug contraception (excluding safe period contraception) after signing the informed consent form.\n\n7\\. Subjects must agree to sign or personally sign an ethics committee-approved informed consent form before starting any screening procedures.\n\nExclusion Criteria:\n\n1. Subjects who have used or required long-term immune-suppressive agents (e.g., cyclosporine or systemic steroids) within 14 days prior to enrollment, but the use of physiological substitutes, intermittent, topical, and inhaled steroids is allowed.\n2. Subjects who have undergone autologous haematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks prior to randomization, or who have previously undergone allogeneic haematopoietic stem cell transplantation (Allo-HSCT).\n3. Subjects received the following anti-tumor treatments before enrollment: (1)Treated with an immunomodulator within 7 days, or; (2)Received plasma exchange, radiotherapy (except local radiotherapy for myeloma-related bone lesions), cytotoxic chemotherapy, treatment with proteasome inhibitors or other investigational drug within 14 days, or; (3) Treatment with monoclonal antibody for multiple myeloma within 21 days, or; (4) Received other anti-cancer therapy within 14 days or at least 5 half-lives (whichever is shorter) prior to enrollment.\n4. Significant cardiac disorder.\n5. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, renal, or metabolic disease requiring medication.\n6. The subject will not be able to participate in this study if the investigator determines that the subject meets any of the following conditions: (1) Subjects with a history of allergic reaction to the excipient components (DMSO and albumin) of Eque-cel, fludarabine, cyclophosphamide, tocilizumab, or; (2) Subjects who are intolerant to dexamethasone, or; (3) Subjects who have a Life-threatening allergy, hypersensitivity reaction, or intolerance to pomalidomide and\u002For its excipients (intolerance is defined as discontinuation of prior treatment due to any AE related to pomalidomide) or;\n7. Have malignancies other than multiple myeloma within 5 years before screening, excluding cervical carcinoma in situ after radical surgery, basal cell or squamous cell skin cancer, localized cancer of prostate after radical prostatectomy, breast ductal carcinoma in situ after radical mastectomy or carcinoma papillary thyroid after radical thyroidectomy.\n8. Subjects suspected or confirmed to have central nervous system involvement of MM during the screening period.\n9. Subjects with concurrent plasma cell leukemia(defined as plasma cell proportion in peripheral blood \\> 5%), Waldenström macroglobulinaemia, POEMS syndrome (polyneuropathy, organ hypertrophy, endocrinopathy, monoclonal protein and skin changes) or primary amyloidosis during screening period.\n10. Have extramedullary multiple myeloma-extraosseous (EM-E); have multiple extramedullary multiple myeloma-bone related (EM-B) and the maximum transverse diameter of any lesion is \\>3cm; have a single EM-B and the maximum transverse diameter of the lesion is \\>3cm.\n11. Had major surgery within 2 weeks prior to randomization or planned to have surgery within 2 weeks after study treatment (except for subjects who were scheduled to have surgery under local anesthesia).\n12. Subject with uncontrollable infection.\n13. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and hepatitis B virus (HBV) DNA quantification in peripheral blood was higher than the lower limit of detection; hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Syphilis test positive; positive cytomegalovirus (CMV) DNA.\n14. Pregnant or breastfeeding women.\n15. The subject has a history of central nervous system disorder within 6 months prior to signing the informed consent form.\n16. Non-hematological toxicity reactions due to prior treatment have not resolved to baseline or ≤ Grade 1 (NCI-CTCAE v5.0, alopecia, Grade 2 peripheral neuropathy were excepted).\n17. Subjects had other conditions that the investigator considered unsuitable for enrollment.","75 Years",{"count":111,"type":22},240,[113],"PHASE3","This is a multicenter, randomized, controlled, open-label, phase III clinical study to evaluate the efficacy of Equecabtagene Autoleucel Injection versus standard therapy in subjects with lenalidomid-refractory RRMM who have received 1-2 lines of prior therapy.",[32],[32,117],"Eque-cel","2025-07-16",{"date":120,"type":39},"2025-07-20",{"date":122,"type":39},"2024-03-27",{"date":124,"type":22},"2030-12",{"name":45,"class":46},28,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100597225","phase-2-study-of-eque-cel-car-t-therapy-in-newly-diagnosed-severe-al-amyloidosis-100597225","NCT07055724","Study of Eque-cel CAR-T Therapy in Newly Diagnosed Severe AL Amyloidosis","Exploratory Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T-cell Injection (Equecabtagene Autoleucel, Eque-cel) for the Treatment of Newly Diagnosed Mayo Stage IIIb AL Amyloidosis Patients","Inclusion Criteria:\n\n1. Subjects aged ≥18 years, regardless of gender.\n2. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n3. Clinically diagnosed with newly diagnosed AL (light chain) amyloidosis, classified as Mayo Stage IIIb per the revised 2004 Mayo Clinic staging system at screening, with serum N-terminal pro-brain natriuretic peptide (NT-proBNP) \\>8500 ng\u002FL and serum cardiac troponin T (cTnT) \\>0.035 μg\u002FL or cardiac troponin I (cTnI) \\>0.01 g\u002FL.\n4. Presence of measurable hematologic disease at screening, defined as at least one of the following:\n\n   1. Difference in free light chains (dFLC) \\>4 mg\u002FdL, or\n   2. Involved free light chain (iFLC) \\>4 mg\u002FdL with abnormal kappa\u002Flambda (κ\u002Fλ) ratio, or\n   3. Serum protein electrophoresis (SPEP) M protein \\>0.5 g\u002FdL.\n5. Histopathological diagnosis of amyloidosis based on polarized light microscopy of Congo red-stained tissue specimens showing green birefringence, with confirmation of AL-derived amyloid deposits by at least one of the following methods:\n\n   1. Immunohistochemistry\u002Fimmunofluorescence,\n   2. Mass spectrometry,\n   3. Electron microscopy for characteristic appearance\u002Fimmunoelectron microscopy.\n6. Presence of clonal plasma cells in bone marrow, detectable by light microscopy or flow cytometry.\n7. Presence of M protein in blood or urine, with exclusion of multiple myeloma, Waldenström macroglobulinemia, or other lymphoplasmacytic proliferative disorders.\n8. Organ involvement: At least one organ affected (kidney, heart, liver, nervous system, gastrointestinal tract, lung, soft tissue) as per consensus guidelines.\n9. Expected survival time ≥12 weeks.\n10. Subjects must have adequate organ function, meeting all of the following laboratory criteria prior to enrollment:\n\n    1. Complete blood count: Absolute neutrophil count (ANC) ≥1×10⁹\u002FL; absolute lymphocyte count (ALC) ≥0.3×10⁹\u002FL.\n    2. Hemoglobin \\>60 g\u002FL (no red blood cell \\[RBC\\] transfusion within 7 days prior to testing; use of recombinant human erythropoietin allowed).\n    3. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN); total serum bilirubin ≤1.5× ULN.\n    4. Renal function: Creatinine clearance (CrCl) ≥30 mL\u002Fmin as calculated by the Cockcroft-Gault formula.\n    5. Coagulation function: Fibrinogen ≥1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤1.5× ULN; prothrombin time (PT) ≤1.5× ULN.\n    6. Blood oxygen saturation \\>91%.\n    7. Echocardiogram showing left ventricular ejection fraction (LVEF) ≥40%.\n    8. Systolic blood pressure (SBP) ≥90 mmHg (oral vasopressor support allowed).\n11. Subjects and their spouses agree to use effective contraceptive methods (tools or medications) from the time of signing the informed consent form until one year after CAR-T cell infusion.\n12. Subjects voluntarily sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Subjects who have received any of the following treatments prior to enrollment:\n\n   1. Gene therapy before enrollment;\n   2. Live vaccine within 4 weeks before enrollment;\n   3. Other interventional clinical trial drugs within 12 weeks before leukapheresis.\n2. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA; positive for syphilis testing.\n3. Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\>20 mg\u002Fday) within 7 days before screening, though physiological replacement, topical, and inhaled steroids are permitted.\n4. Presence of uncontrolled active infection within 7 days before peripheral blood mononuclear cell (PBMC) collection (excluding genitourinary system infections and upper respiratory tract infections \\\u003CCTCAE Grade 2).\n5. Receipt of any systemic therapy for AL amyloidosis within 14 days before PBMC collection.\n6. Undergoing major surgery within 14 days before PBMC collection, or planning surgery within 2 weeks after study treatment (subjects planning local anesthesia surgery are eligible to participate).\n7. Unresolved non-hematologic toxicity from prior therapy to baseline or ≤Grade 1 (per NCI-CTCAE v5.0, excluding alopecia and Grade 2 peripheral neuropathy).\n8. Known life-threatening allergic reaction, hypersensitivity, or intolerance to cellular products or their components.\n9. Subjects with suspected or confirmed symptoms of central nervous system (CNS) involvement by plasma cell tumors.\n10. Bone marrow plasma cells \\>30% with clinical symptoms of multiple myeloma accompanied by osteolytic bone lesions.\n11. Severe active cardiovascular disease with significant clinical symptoms despite treatment, including but not limited to unstable angina, myocardial infarction, and severe arrhythmia (excluding those with implanted implantable cardioverter-defibrillator \\[ICD\\] or pacemaker).\n12. Subjects with bleeding or severe thrombosis symptoms as judged by the investigator, or with genetic\u002Facquired bleeding and severe thrombosis conditions (including hemophilia, coagulopathy, thrombocytopenia, splenomegaly), or currently receiving thrombolytic or anticoagulant therapy.\n13. Subjects with hypertension that cannot be controlled by medication.\n14. Subjects who have received solid organ transplantation.\n15. Subjects with a history of central nervous system disorders (e.g., cerebral aneurysm, epilepsy, stroke, dementia, psychosis) or consciousness impairment.\n16. Subjects with unstable systemic diseases as judged by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring medical treatment.\n17. Diagnosis of malignancy other than multiple myeloma within 5 years before screening, excluding adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer post-radical surgery, or ductal carcinoma in situ of the breast post-radical surgery.\n18. Participation in another interventional clinical trial within 1 month before signing the ICF.\n19. Women who are pregnant, breastfeeding, or planning to become pregnant.\n20. Subjects who do not agree to or have not completed the signing of the ICF.\n21. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":21,"type":22},[26],"The goal of this clinical trial is to learn if Equecabtagene Autoleucel(Eque-cel), a Chimeric Antigen Receptor T-cell (CAR-T) therapy, works to treat severe Light Chain (AL) Amyloidosis in newly diagnosed adults with Mayo Stage IIIb. It will also learn about the safety and effects of Eque-cel. The main questions it aims to answer are:\n\nDoes Eque-cel lead to hematologic remission (achieving a very good partial response or better) in AL amyloidosis? How safe is Eque-cel for these patients, and what side effects might occur?\n\nParticipants will:\n\nUndergo blood cell collection to create personalized Eque-cel therapy. Receive pre-treatment to prepare their body for the therapy (lymphodepletion). Receive a single infusion of Eque-cel. Be monitored closely for 24 weeks after infusion, followed by long-term checkups for up to 15 years.",[138],"AL Amyloidosis",[117,34,140],"Mayo Stage IIIb","2025-07-03",{"date":143,"type":39},"2025-07-09",{"date":145,"type":22},"2025-07",{"date":147,"type":22},"2027-06",{"name":45,"class":46},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":155,"targetDuration":157,"studyType":158,"phases":4,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100595170","long-term-follow-up-registry-study-of-equecabtagene-autoleucel-injection-100595170","NCT07028970","Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection","Inclusion Criteria:\n\n\\- 1.Received Equecabtagene Autoleucel Injection treatment; 2.For those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.\n\nExclusion Criteria:\n\n* 1\\. Receipt of another lentiviral vector-based cell or gene therapy (either commercialized product or investigational product in a clinical tiral) between the infution of Equecabtagene Autoleucel Injection and the signing informed consent.",{"count":156,"type":22},1500,"15 Years","OBSERVATIONAL","This is a multicenter, open-label, single-arm, long-term follow-up clinical study. All patients who have received Equecabtagene Autoleucel Injection treatment will be enrolled.",[32],[162,117],"Long term follow up;","2025-06-11",{"date":165,"type":39},"2025-06-19",{"date":167,"type":39},"2024-12-15",{"date":169,"type":22},"2043-12",{"name":45,"class":46},6,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":75},"100497634","phase-1-a-study-of-car-gprc5d-in-patients-with-relapsedrefractory-multiple-myeloma-or-plasma-cell-leukemia-100497634","NCT05759793","A Study of CAR-GPRC5D in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (CAR-GPRC5D) in Patients With Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Inclusion Criteria:\n\nSubjects must satisfy all the following criteria to be enrolled in the study:\n\n1. age 18 to 75 years old, male or female.\n2. Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs).\n\n   According to the International Myeloma Working Group (IMWG) consensus (2016) standard on multiple myeloma, the disease has recurred, progressed or is refractory, or according to the IMWG consensus (2013) standard on plasma cell leukemia (Appendix 4), the disease appears relapse, progress or refractory;\n3. Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).\n4. The subjects should have measurable disease based on at least one of the following parameters:\n\n   1. The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow cytometry is ≥ 10%.\n   2. Serum M-protein ≥ 10 g\u002FL for IgG type, serum M-protein ≥ 5 g\u002FL for other types, such as IgA, IgD, IgM, IgE.\n   3. Urine M-protein ≥ 200 mg\u002F24 hrs.\n   4. For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain (sFLC) : involved sFLC level ≥ 10mg\u002FdL (100 mg\u002FL) provided serum FLC ratio is abnormal.\n   5. In subjects with extramedullary myeloma, if there are no other evaluable lesions, require extramedullary lesions with a maximum diameter of ≥2cm\n5. ECOG performance score 0-2.\n6. Estimated life expectancy ≥ 12 weeks.\n7. Subjects should have adequate organ function:\n\n   1. Hematology: Absolute neutrophil count (ANC) ≥1×10\\^9 \u002FL (prior use of growth factor support is permitted, but subjects must not have received supportive treatment within 7 days prior to laboratory examination); absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL; platelets ≥40×10\\^9 \u002FL (subjects must not have received blood transfusion support within 7 days prior to laboratory examination); hemoglobin ≥60 g\u002FL (subjects must not have received transfusion of red blood cells \\[RBC\\] within 7 days prior to laboratory examination; the use of recombinant human erythropoietin is permitted).\n   2. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.\n   3. Renal function: Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml\u002Fmin.\n   4. Coagulation function: Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤1.5×ULN.\n   5. SpO2 \\> 91%.\n   6. Left ventricular ejection fraction (LVEF) ≥ 50%.\n8. The subject and his\u002Fher spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) for one year from the date of the subject's informed consent to the date of CAR T cell infusion.\n9. Subject must sign the informed consent form approved by ethics board in person before starting any screening procedure.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a subject from enrollment:\n\n1. Subjects who are known to have GVHD or need long-term immunosuppressive therapy.\n2. Subjects have received any anti-cancer treatment as follows:\n\n   monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis, or immunomodulatory agents within 7 days before leukapheresis. or anti-tumor treatments other than those listed above within 30 days before leukapheresis.\n3. Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \\> 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.\n4. Subjects with hypertension that cannot be controlled by medication.\n5. Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.\n6. Subjects with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.\n7. Subjects with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.\n8. Subjects with a history of organ transplantation.\n9. Subjects have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia).\n10. Subjects participated in another interventional clinical study 1 months before signing the informed consent (ICF);\n11. Subjects with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis collection (excluding # CTCAE grade 2 urogenital infection and upper respiratory infection).\n12. Positive for any of the following tests:\n\n    Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody; Cytomegalovirus (CMV) DNA; Treponema Pallidum antibody\n13. Pregnant or lactating women.\n14. Subjects with mental illness or consciousness disorder or disease of the central nervous system\n15. Other conditions that researchers consider inappropriate for inclusion.",{"count":180,"type":22},12,[25],"This study is a single-center, open-label, dose-escalation study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R\u002FR MM or Plasma Cell Leukemia.",[29,184],"Plasma Cell Leukemia",[186,187,188],"GPRC5D","RRMM","PCL","2025-05-15",{"date":191,"type":39},"2025-05-20",{"date":193,"type":39},"2023-03-30",{"date":195,"type":22},"2026-10-01",{"name":45,"class":46},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},"100453204","phase-1-a-study-of-fully-human-bcma-car-t-ct103a-in-patients-with-newly-diagnosed-high-risk-multiple-myeloma-fumanba-2-100453204","NCT05181501","A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)","A Multi-center Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T (CAR-T) Cell Injection (CT103A) in the Treatment of Newly Diagnosed Subjects With High-risk Multiple Myeloma (FUMANBA-2)","Inclusion Criteria:\n\n1. 18 to 70 years old, male or female;\n2. Newly diagnosed as high-risk multiple myeloma:\n\n   * Revised Multiple Myeloma International Staging System (R-ISS) stage 3;\n   * Double-hit or triple-hit according to FISH test.\n3. Presence of measurable lesions during screening according to any of the following criteria:\n\n   * The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow cytology, bone marrow biopsy histology or flow cytometry;\n   * Serum monoclonal protein (M-protein) level: M protein ≥10 g\u002FL for IgG type, M protein ≥5g\u002FL for IgA, IgD, IgM, and IgE type;\n   * Urine M protein level ≥200 mg\u002F24 hours;\n   * Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg\u002FL with abnormal serum κ\u002Fλ free light chain ratio;\n4. ECOG score of 0 or 1;\n5. Expected survival time ≥ 12 weeks;\n6. Subjects must have appropriate organ functions and meet all the following laboratory test requirements before enrollment:\n\n   * Hematology: Absolute neutrophil count (ANC) ≥ 1×10\\^9\u002FL (prior growth factor support is allowed, but supportive treatment within 7 days before laboratory test is not allowed); Absolute lymphocyte count (ALC) )≥0.3×10\\^9\u002FL; platelets≥75×10\\^9\u002FL (blood transfusion support within 7 days before laboratory test is not allowed); hemoglobin ≥60 g\u002FL (without red blood cell \\[RBC\\] transfusion within 7 days before laboratory test; recombinant human erythropoietin is allowed);\n   * Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×upper limit of normal (ULN); serum total bilirubin≤1.5×ULN;\n   * Renal function: creatinine clearance calculated according to Cockcroft-Gault formula≥ 40 ml\u002Fmin.\n   * Coagulation function: fibrinogen ≥1.0 g\u002FL; activated partial thromboplastin time≤1.5×ULN, prothrombin time (PT)≤1.5×ULN;\n   * Blood oxygen saturation\\>91%;\n   * Left ventricular ejection fraction (LVEF) ≥50%;\n7. Subjects and their spouses agree to take effective tools or contraceptive measures (safe period contraception is not included) from the time the subject signs the informed consent form until one year after the CAR-T cell infusion.\n\nExclusion Criteria:\n\n1. Patient who needs chronic use of immunosuppressive agents;\n2. Patient with hypertension that cannot be controlled by medication;\n3. Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade III), severe arrhythmia;\n4. Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases that require drug treatment;\n5. Patients with malignant tumors other than multiple myeloma within 5 years before screening, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and those after radical resection Ductal carcinoma in situ of breast;\n6. Patient with a history of solid organ transplantation;\n7. Patient who is suspected with or with symptoms of central nervous system invasion by plasma cell tumors;\n8. Multiple myeloma patients with plasma cell leukemia;\n9. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and detectable hepatitis B virus (HBV) DNA in peripheral blood; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus ( HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test positive; syphilis test positive;\n10. Women who are pregnant or breastfeeding;\n11. Patient with mental illness or disturbance of consciousness or central nervous system disease;\n12. Major surgery history within 2 weeks before entering the study, or scheduled surgery during the study period or within 2 weeks after the study treatment;\n13. Other situations considered unsuitable by the investigator.",{"count":205,"type":22},20,[25],"This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.",[32],[210,211,212,34],"newly diagnosed","multiple myeloma","treatment naive","2022-01-03",{"date":215,"type":39},"2022-01-06",{"date":217,"type":22},"2022-04",{"date":219,"type":22},"2039-04",{"name":45,"class":46},4,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":4},"100446292","phase-1-a-phase-12-study-of-ct120-in-patient-with-relapsedrefractory-b-cell-non-hodgkins-lymphoma-100446292","NCT05091541","A Phase 1\u002F2 Study of CT120 in Patient With Relapsed\u002FRefractory B-cell Non-Hodgkin's Lymphoma","A Multicenter Phase I\u002FII Clinical Study on Fully Human Anti-CD19\u002FCD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection (CT120) for the Treatment of Relapsed\u002FRefractory B-cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Age between 18 and 70 years old.\n2. Pathologically confirmed B-cell non-Hodgkin's lymphoma, including:\n\n(1) Diffuse large B-cell lymphoma (DLBCL); (2) Histopathological Grade 3b follicular lymphoma (FL3b); (3) Follicular lymphoma with diffuse large B cell transformation; (4) Primary mediastinal large B-cell lymphoma (PMBCL). 3. Relapsed\u002Frefractory B-cell non-Hodgkin's lymphoma must meet one of the following criteria:\n\n1. At least 2 failed prior B-cell non-Hodgkin's lymphoma treatment regimens (including relapse, no response, and progression). Prior therapy must have included anti-CD20 monoclonal antibodies (except for CD20-negative subjects) and standard therapies which including anthracyclines;\n2. Recurrence after autologous hematopoietic stem cell transplantation;\n3. Primary resistance: After 2 cycles of initial anti-CD20 monoclonal immunochemotherapy, the best response was stable disease or disease progression.\n\n4\\. At least 1 measurable lesion as following:\n\n1. The long axis of the lymph node lesions should be ≥15mm (and the length of the short axis is measurable), or;\n2. The lengths of extra-lymph node lesions should be ≥10mm in both the long and short axis.\n\n5\\. Expected survival time≥12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate organ function before enrollment, and meet all the following laboratory test results:\n\n1. Blood routine: neutrophils ≥1.0 ×109\u002FL (granulocyte colony stimulating factor (G-CSF) is allowed within 7 days before the examination), lymphocytes ≥0.3 ×109 \u002FL, platelets ≥50 ×109 \u002FL (must have not received blood transfusion \\[including component transfusion\\] or treatments that include thrombopoietin \\[TPO\\] for the purpose of raising platelets within 7 days before the examination), hemoglobin ≥80g\u002FL (must have not received blood transfusion \\[including component blood transfusion\\] within 7 days before the examination);\n2. Blood coagulation function: fibrinogen≥1.0g\u002FL; activated partial thromboplastin time≤1.5×ULN, prothrombin time (PT)≤1.5×ULN;\n3. Liver function: ALT and AST≤2.5×ULN; serum total bilirubin≤1.5×ULN;\n4. Renal function: creatinine clearance rate CrCl ≥60 mL\u002Fmin estimated by Cockcroft-Gault;\n5. Left ventricular ejection fraction (LVEF)≥50% estimated by echocardiography;\n6. Baseline oxygen saturation \\> 91% on room air. 8. Females and males with childbearing potential should take effective contraception from the day of signing the informed consent form to 365 days after the CT120 infusion. Effective contraception is defined as: abstinence or contraceptive methods with an annual failure rate of \\\u003C1% indicated in section 9.8 of this protocol.\n\n9\\. Subject is willing to participate in this trial and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Subjects who have received or require the following treatments:\n\n(1) Prior CAR-T cell therapy before enrollment; (2) Presence of acute or chronic graft-versus-host disease (GVHD) requires systemic treatment within 4 weeks before enrollment; (3) History of immunodeficiency or other diseases and autoimmune diseases (eg Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) received immunosuppressive therapy within 2 years before enrollment; (4) Autologous hematopoietic stem cell transplantation (autoSCT) within 12 weeks before enrollment and history of allogeneic stem cell transplantation (HSCT); (5) Live vaccines injection within 4 weeks before enrollment; (6) According to investigator's discretion, there is a need to use systemic corticosteroid therapy within 12 weeks after the administration of the study drug (except for hydrocortisone ≤12mg\u002Fm2\u002Fday or other hormones converting into the same dose range for physiological replacement therapy) or other immunosuppressive drug therapy (except local therapy).\n\n2\\. B-cell non-Hodgkin's lymphoma patients with active central nervous system or intestinal parenchyma invasion.\n\n3\\. Excessive tumor burden and any lesions with a long axis ≥10cm. 4. Other active malignant tumors in the past 5 years, except for curable tumor that has been completely cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.\n\n5\\. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and an abnormal HBV DNA result detected by peripheral blood test (abnormal HBV DNA result is defined as: the quantitative detection of HBV DNA is over the detectable lower limit or beyond the normal reference of the testing center or HBV viral DNA positive); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA test positive; syphilis test positive.\n\n6\\. Uncontrollable active infections (except for genitourinary system infections and upper respiratory tract infections \\\u003C CTCAE Grade 2).\n\n7\\. Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ Grade III), severe arrhythmia.\n\n8\\. Hypertension that cannot be controlled by medication. 9. Adverse events during prior therapies have not relieved to baseline or ≤1 (according to NCI-CTCAE v5.0, except for alopecia).\n\n10\\. Major surgery within 2 weeks before enrollment, or surgeries that were planed while waiting for infusion or within 12 weeks after receiving investigational product (except planned local anesthesia surgery).\n\n11\\. History of organ transplant. 12. Pregnant or lactating women. 13. Previous central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, mental illness, etc.) or mental disorders.\n\n14\\. Unstable systemic diseases judged by other researchers: including but not limited to severe liver, kidney, or metabolic diseases that require medication.\n\n15\\. Other unsuitable situations for enrollment judged by investigators.",{"count":230,"type":22},125,[25,26],"This study is a single-armed, open-label,multicenter Phase 1\u002F2 study to evaluate the safety and efficacy of CT120 in subjects with relapsed\u002Frefractory B-cell non-Hodgkin's lymphoma.",[234],"B-cell Non-Hodgkin's Lymphoma","2021-10-12",{"date":237,"type":39},"2021-10-25",{"date":239,"type":22},"2021-10-20",{"date":241,"type":22},"2039-10-20",{"name":45,"class":46},""]