[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-multiple-myeloma-mm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-multiple-myeloma-mm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100628209","early-phase-1-clinical-study-of-bcma-targeted-car-t-cell-injection-in-the-treatment-of-patients-with-relapsedrefractory-multiple-myeloma-100628209",false,"NCT07458659","Clinical Study of BCMA-Targeted CAR T-Cell Injection in the Treatment of Patients With Relapsed\u002FRefractory Multiple Myeloma","Phase Ib Clinical Study of BCMA-Targeted Chimeric Antigen Receptor T-Cell Injection (CART-BCMA) in the Treatment of Patients With Relapsed\u002FRefractory Multiple Myeloma","CART-BCMA","Inclusion Criteria:\n\n1. Age above 18 years old (inclusive), regardless of gender.\n2. Patients with multiple myeloma who have received at least three lines of treatment for multiple myeloma and have failed at least after treatment with proteasome inhibitors and immunomodulators; At least one complete cycle of each line of therapy, unless the best response to that therapy was documented as progressive disease (PD) (according to the 2016 published IMWG criteria for efficacy evaluation, Appendix 4); Patients must have PD records during or within 12 months after the last treatment or no response (no MR or better response) within 60 days after the last treatment.\n3. The presence of measurable lesions at screening was defined as any of the following:\n\n   * Serum M protein ≥ 1 g\u002FdL (≥ 10 g\u002FL)\n   * Urinary M-protein level ≥ 200 mg\u002F24 hours\n   * Serum free light chains (FLC): abnormal serum FLC ratio (\\\u003C 0.26 or \\> 1.65) with involved FLC ≥ 10 mg\u002FdL (100 mg\u002FL)\n4. ECOG Performance Status (Appendix 1) of 0-1.\n5. Expected survival time ≥ 3 months.\n6. Meets the following criteria prior to mononuclear cell apheresis:\n\n   Hematology\n   * Absolute count of lymphoid cells ≥ 0.5×109\u002FL \\[Granulocyte colony-stimulating factor (G-CSF) is allowed, but this supportive treatment shall not be received by the test subjects within 7 days before laboratory tests during the screening period\\];\n   * Absolute neutrophil count ≥ 1.0 ×109\u002FL \\[Granulocyte colony-stimulating factor (G-CSF) is allowed, but the subjects shall not receive this supportive treatment within 7 days before laboratory tests during the screening period\\];\n   * Platelet count ≥ 50×109\u002FL (subjects must not receive blood transfusion support within 7 days before the screening laboratory test);\n   * Hemoglobin ≥ 8.0 g\u002FdL (recombinant human erythropoietin is allowed) \\[subjects have not received red blood cells (RBCS) within 7 days prior to screening laboratory testing\\]; Heart\n   * Ejection function: Left ventricular ejection fraction (LVEF) ≥ 50% Lungs\n   * Oxygen saturation: A blood oxygen saturation of ≥ 91% on non-oxygen therapy Kidneys\n   * Creatinine clearance (CrCl) or glomerular filtration rate (GFR) (Cockcroft-Gault formula) ≥ 30 mL\u002Fmin Liver\n   * Total bilirubin (serum) ≤ 1.5 × ULN Patients with Gilbert's disease and a serum bilirubin level of more than 1.5 × ULN could be enrolled after approval from the sponsor\n   * AST and ALT ≤ 3× ULN Clotting\n   * PT ≤ 1.5× ULN, APTT ≤ 1.5×ULN, INR ≤ 1.5×ULN\n7. Peripheral venous access can meet the requirements of apheresis and intravenous infusion.\n8. Subjects agreed to use a reliable contraceptive method for contraception from the time they signed the informed consent form until 1 year after infusion. These include, but are not limited to: abstinence, vasectomy in men, and an implantable progestin-based contraceptive that suppresses ovulation; Intrauterine contraceptive devices; Hormone-releasing intrauterine devices; Sexual partner sterilization; Copper intrauterine devices, proper use of combined hormonal contraceptives that have been shown to inhibit ovulation; Progestin-based contraceptives that inhibit ovulation. Female subjects should be at the same time commitment to lose after 1 year not to donate eggs (eggs, oocyte) used for assisted reproduction.\n9. They should voluntarily participate in the clinical trial and sign the informed consent.\n\nExclusion Criteria:\n\n1. Subjects with a known history of allergy, hypersensitivity, intolerance, or contraindication to any component of CART-BCMA or drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab); or subjects allergic to beta-lactam antibiotics; or subjects with a history of severe allergic reactions.\n2. Subjects who have previously received any CAR-T therapy or BCMA-targeted therapy.\n3. Subjects who have received the following anti-multiple myeloma (anti-MM) treatments within the specified time frame before apheresis:\n\n   * Small-molecule targeted therapy within 4 weeks or five half-lives, whichever was longer\n   * Macromolecular drug therapy within 4 weeks or 2 half-lives (whichever is longer)\n   * Cytotoxic therapy or proteasome inhibitor within 2 weeks\n   * Immunomodulatory drug therapy within 1 week\n   * Radiotherapy within 1 week\n4. Subjects who have received any investigational drug within 4 weeks prior to apheresis or are concurrently participating in another clinical study (except for the following: subjects participating in observational, non-interventional clinical studies, or those in the follow-up period of an interventional clinical study).\n5. Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to apheresis or have previously received allogeneic stem cell transplantation (with no time limit).\n6. Subjects who have received live vaccines or attenuated vaccines within 4 weeks prior to CART-BCMA apheresis.\n\n   Note: Administration of inactivated viral vaccines for seasonal influenza via injection is permitted; however, intranasal attenuated live influenza vaccines are not permitted.\n7. Subjects who have received any of the following treatments within 7 days prior to apheresis, or are judged by the investigator to require long-term receipt of such treatments during the study:\n\n   * Cumulative corticosteroids use equivalent to ≥ 70 mg prednisone within 7 days prior to apheresis, or long-term receipt of therapeutic-dose corticosteroids during the study as judged by the investigator\n   * Immunosuppressive therapy\n   * Graft-versus-host disease therapy\n   * Central nervous system (CNS) prophylactic therapy\n8. Toxicities resulting from previous treatments (including peripheral neuropathy) have not fully resolved or stabilized to Grade 1 (per NCI-CTCAE v5.0), except for those judged by the investigator to not affect the patient's safe receipt of treatment (e.g., alopecia).\n9. Any clinically significant past or current history of CNS disorders, such as altered mental status, psychosis, dementia, neurocognitive, neurodegenerative, or neuroinflammatory diseases (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis), epilepsy, seizures, hemiplegia, aphasia, stroke, subarachnoid hemorrhage or other CNS hemorrhage, and severe traumatic brain injury. For subjects with history of such CNS alterations, they must have fully recovered at least 1 year before administration.\n10. Presence of meningeal, brainstem, spinal cord metastasis and\u002For compression, or active CNS metastasis; or suspected involvement of the CNS or meninges by multiple myeloma (MM), confirmed by magnetic resonance imaging (MRI) or computed tomography (CT).\n11. Suspected involvement of the CNS or meninges by MM (confirmed by MRI or CT), or presence of other active CNS diseases.\n12. Patients with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes), or amyloidosis at screening.\n13. Cardiac diseases: Current heart failure (New York Heart Association \\[NYHA\\] classification ≥ Class II, Appendix 2); severe cardiac diseases as determined by the investigator; myocardial infarction occurring ≤ 6 months before apheresis; unstable angina pectoris, severe arrhythmia (as judged by the investigator), or coronary artery bypass grafting (CABG) performed ≤ 3 months before apheresis.\n14. Poorly controlled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy.\n15. Patients who have undergone major surgery (other than diagnostic procedures or biopsies) or plasmapheresis within 4 weeks before apheresis or are expected to undergo major surgery during the study. Note: Patients scheduled for surgical procedures under local anesthesia may participate in the study. Kyphoplasty or vertebroplasty is not considered major surgery.\n16. Subjects currently receiving thrombolytic, anticoagulant, or antiplatelet therapy.\n17. Subjects with infections requiring intravenous antibiotic administration or hospitalization.\n18. Subjects with active hepatitis B; subjects positive for hepatitis C virus (HCV) antibody and positive for HCV RNA; subjects positive for human immunodeficiency virus (HIV) antibody; subjects positive for syphilis screening antibody;\n\n    a) Non-active\u002Fasymptomatic carrier, chronic, or active HBV-infected subjects may be enrolled if they meet the following criteria: HBV deoxyribonucleic acid (DNA) \\\u003C 500 IU\u002FmL (or 2500 copies\u002FmL) at screening.\n19. Pregnant or lactating women.\n20. Subjects diagnosed with or treated for other invasive malignant tumors except multiple myeloma, except for the following cases: non-melanoma skin cancer that has been surgically removed, cured cervical carcinoma in situ, localized prostate cancer, low-stage bladder cancer, ductal carcinoma in situ of the breast, or malignant tumors with no recurrence and no treatment within 2 years before enrollment.\n21. Subjects deemed by the investigator to be unsuitable for participation in this clinical study due to any clinical or laboratory abnormalities or other reasons.","ALL","18 Years",{"count":20,"type":21},3,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","A Phase 1b clinical trial to evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma.",[27],"Relapsed\u002FRefractory Multiple Myeloma (MM)",[29,15,30,31],"Relapsed\u002FRefractory Multiple Myeloma","BCMA","CAR T-cell","NOT_YET_RECRUITING","2026-03-04",{"date":35,"type":36},"2026-03-09","ACTUAL",{"date":38,"type":21},"2026-06-01",{"date":40,"type":21},"2029-06-01",{"name":42,"class":43},"Chulalongkorn University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100618577","phase-1-study-of-naive-hbi0101-car-t-therapy-in-relapsedrefractory-multiple-myeloma-100618577","NCT07333430","Study of Naive HBI0101 CAR-T Therapy in Relapsed\u002FRefractory Multiple Myeloma","A Phase 1a\u002F1b Open-Label Study With Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. ≥18 years of age at the time of signing informed consent.\n2. Voluntarily signed informed consent form.\n3. Diagnosis of relapsed\u002Frefractory multiple myeloma (Parts 1a and 1b), with measurable disease at screening visit as follows:\n\n   Multiple Myeloma (at least one of the criteria below):\n   1. Serum M-protein greater or equal to 0.5 g\u002FdL.\n   2. Urine M-protein greater or equal to 200 mg\u002F24 h.\n   3. Serum free light chain (FLC) assay: involved FLC level greater or equal to 3 mg\u002FdL (30 mg\u002FL) provided serum FLC ratio is abnormal.\n   4. A biopsy-proven evaluable plasmacytoma\\*.\n   5. Bone marrow plasma cells \\> 10% of total bone marrow cells\\*.\n   6. Non secretory patient will be allowed provided they have measurable disease by PET-CT or bone marrow aspiration, as designated\\*.\n\n      * Results pre-dating the Screening visit by up to 28 days may be used to establish eligibility.\n4. R\u002FR MM subjects must have been exposed to at least three prior lines of therapy including the following agents:\n\n   1. proteasome inhibitor\n   2. immunomodulatory (IMiDs) agent\n   3. anti-CD38 antibody\n5. For part 1a: At least one of the following risk factors: a. Extra-medullary disease (EMD) - defined as a MM lesion that is not connected to a bone. b. previous exposure to an anti-BCMA therapy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.\n7. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.\n8. Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy, and toxicities that are irreversible and not expected to interfere with study treatment or pose safety concerns, per investigator judgement.\n9. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n10. For subjects with relapsed multiple myeloma who have previously undergone allogenic stem cell transplantation: no evidence of graft versus host disease after cessation of any immunosuppressive therapy for at least one month before recruitment to the study.\n\nExclusion Criteria:\n\n1. Contraindication to a study treatment\u002Fprocedure or is anticipated to receive treatment\u002Fprocedure that may preclude performance of study procedures.\n2. Known bulky central nervous system disease.\n3. Inadequate hepatic function defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN) and\u002For direct bilirubin \\> 4x ULN.\n4. Inadequate renal function defined by estimated clearance of \\\u003C20(ml\u002Fmin).\n5. International ratio (INR) or partial thromboplastin time (PTT) \\> 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an exclusion criteria).\n6. Inadequate bone marrow function defined by absolute neutrophil count (ANC) \\\u003C 1000 cells\u002Fmm3, platelet count \\\u003C 30,000 mm3, or hemoglobin \\\u003C 8 g\u002FdL. Subjects with absolute lymphocyte count \\\u003C 300 cells\u002Fmm3 may be excluded (due to potential challenges with producing CART), per investigator judgement.\n7. Left ventricular ejection fraction \\\u003C 40%.\n8. Ongoing treatment with chronic immunosuppressant such as cyclosporine or systemic steroids (physiological replacement doses of steroids are allowed up to 12 mg\u002Fm2\u002Fd hydrocortisone or equivalent)\n9. Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions.\n10. Known human immunodeficiency virus (HIV) positive status.\n11. Active Hepatitis B active infection (defined as HBS-antigen and HBV DNA positive) or Hepatitis C active infection (defined as anti-HCV and HCV RNA positive).\n12. Active CMV infection.\n13. Known history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.\n14. Chronic atrial fibrillation with uncontrolled heart rate.\n15. Second primary malignancy that has required therapy in the last 2 years or is not in complete remission. This exclusion criterion does not exclude the following subjects: successfully treated non- metastatic basal cell or squamous cell skin carcinoma, or prostate cancer under control with hormonal therapy\n16. Subjects who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and who meet any of the following criteria:\n\n    1. Have been on a stable dose of anticoagulation for \\\u003C 1 month (except for acute line insertion induced thrombosis.\n    2. Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days\n    3. Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).\n17. Pregnant or lactating women.",{"count":53,"type":21},60,[55],"PHASE1","A Phase 1a\u002F1b Open-Label Study with Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed\u002FRefractory Multiple Myeloma.",[27],[59],"Multiple Myeloma (MM)","RECRUITING","2025-12-30",{"date":63,"type":36},"2026-01-12",{"date":65,"type":21},"2026-01-15",{"date":67,"type":21},"2030-12-01",{"name":69,"class":43},"Hadassah Medical Organization"]