Clinical trial · Interventional
Study of BCMA CAR-T in Multiple Myeloma
Clinical Study on the Safety and Efficacy of Anti-BCMA CAR T Cells With Relapsed and Refractory Multiple Myeloma
NCT03559764CI-TRIAL-00033337unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single centre、single arm、open-label,to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed and Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-BCMA CAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-BCMA CAR T cells
- description
- Total dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively).
- interventionNames
- Biological: Anti-BCMA CAR T cells
Primary outcomes (1)
- measure
- The safety of CAR T is evaluated to determine if CRS occurred
- timeFrame
- Day 3-Year 2 after injection
- description
- defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, 18 to 70 years old (including 18 and 70 years old) 2. BCMA antigen diagnosed by pathology and histological examination was positive 3. ECOG ≤2,and the excepted survival ≥ 3 months 4. Patients with BCMA+ myeloma who received ≥ 1 line of chemoradiotherapy or tumor relapsed 5. The main organs function is good; (1) liver function: ALT/AST\<3 times normal value upper limit (ULN) and total bilirubin \<34.2 (mol/L); (2) renal function: creatinine \<220 mu /L,GFR \> 30mL/min; (3) lung function: blood oxygen saturation is greater than 95%; (4) cardiac function: left ventricular ejection fraction (LVEF) is greater than 50%; 6. Platelets \> 40 billion/L; 7. Patients without any anti-cancer treatment such as chemotherapy,radiotherapy, immunotherapy( immunosuppressive drugs )within 2-4 weeks before, and the treatment-related toxicity reaction ≤1 level prior to enrollment(except low toxicity lose hair for example) 8. Venous channel is unobstructed, which can meet the needs of intravenous drip; 9. Voluntary informed consent is given, agree to follow the trial treatment and visit plan. Exclusion Criteria: 1. Patients with allergy to large molecules such as antibodies or cytokines; 2. More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to 4 weeks prior enrollment; 3. Patients with severe autoimmune diseases or immunodeficiency diseases; 4. Patients treated with other immune cellular products (DC, CIK, T, NK, and CART products with CD19 or other targets); 5. Patients with uncontrollable infectious disease in the first 4 weeks of treatment; 6. Active hepatitis B DNA \> 1000copy/mL/ , hepatitis C positive, (HCV positive resistance, HCV RNA positive); 7. Patients participated in other clinical trials within 6 weeks prior enrollment; 8. Patients with mental illness; 9. Patients with drug abuse/addiction and medical, psychological or social conditions may interfere with the study or evaluate the results of the study; 10. Patients have alcohol dependence; 11. Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period; 12. Patients had other conditions that were not appropriate for the group determined by the researchers.
References
Publications (0)
Data not yet available
No reference posted for this study.