Clinical trial · Interventional
Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
Study Evaluating the Safety and Efficacy With Sequential Infusion of Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
NCT04194931CI-TRIAL-00042163unknownPhase 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 arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+,CD19+ relapsed or 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 or Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous BCMA CAR-T cells and CD19 CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mixed BCMA/CD19 CAR-T Transfer
- description
- Subjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts
- interventionNames
- Biological: Autologous BCMA CAR-T cells and CD19 CAR-T cells
Primary outcomes (4)
- measure
- Overall response rate (ORR)
- timeFrame
- 2 year
- description
- Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment
- measure
- minimal residual disease(MRD)
- timeFrame
- 2 year
- description
- Assessment of MRD negative overall response rate at 3 months of 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 aged 18-70 years old 2. Estimated Survival time \> 12 weeks 3. Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging 4. Chemotherapy failure or recurrent multiple myeloma 5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level 6. Bilirubin\<2.0mg/dl 7. Karnofsky Performance Status\>50% at the time of screening 8. Adequate pulmonary, renal, hepatic, and cardiac function 9. Fail in autologous haemopoietic stem cell transplantation 10. Not suitable for stem cell transplantation conditions or abandoned due to conditions 11. Free of leukocytes removal contraindications 12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent Exclusion Criteria: 1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months 2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.) 3. The patient is an active hepatitis B or hepatitis C infection 4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated 5. Abnormal vital signs 6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation. 7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2 8. General infection or local severe infection, or other infection that is not controlled 9. Dysfunction in lung, heart, kidney and brain 10. Severe autoimmune diseases 11. Other symptoms that are not applicable for CAR-T
References
Publications (0)
Data not yet available
No reference posted for this study.