Clinical trial · Interventional
CAR-T Cells Therapy in Relapsed/Refractory Multiple Myeloma
The Prospective, Multi-center And Single-arm Clinical Study of Chimeric Antigen Receptor T(CAR-T) Cells Therapy in Relapsed/Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After CAR-T treatment, the benefit is not significant, and it is difficult to enroll.
Summary
Brief summary (as posted)
Multiple myeloma(MM) is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy.The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, and several clinical trials have been reported in the treatment of multiple myeloma with CAR-T cells.
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/Refractory Multiple Myeloma(MM) | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART therapy in Relapsed/Refractory multiple myeloma | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CART therapy in multiple myeloma
- description
- In order to assess the safety and validity of using CAR-T therapy refractory/rela-psed multiple myeloma patients with one kind of BCMA-CART,CD138-CART,CD56-CART or CD38-CART,subjects will receive 10\^6-10\^7/Kg transduced CAR T cells at one time.
- interventionNames
- Biological: CART therapy in Relapsed/Refractory multiple myeloma
Primary outcomes (1)
- measure
- Adverse events that Are related to treatment
- timeFrame
- 2 years
- description
- Determine the toxicity profile of the BCMA/CD138/CD38/CD56-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
Secondary outcomes (3)
- measure
- Estimate 2 year overall survival(OS) after infusion of BCMA/CD138/CD38/CD56-CART and sequential treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Relapsed/Refractory MM patients 2. Cell phenotype is BCMA/CD138/CD38/CD56 positive (single or combined) ,and minimal residual disease (MRD) was positive(cytology, genetic testing) 3. Estimated survival time is more than 3 months in multiple myeloma,and Karnofsky performance status(KPS) score is more than 60. 4. No cytapheresis and cell separation contraindication. 5. Hemoglobin is more than 80 gram per litre. 6. The function of important organ was satisfied:(1)cardiac ultrasound indicated that cardiac ejection fractions is more than 50%(EF≥50%), and the electrocardiogram showed no obvious abnormality;(2)Blood oxygen saturation is more than 90%(SpO2≥90%);(3)Creatinine(Cr) is less than 2.5 times normal range;(4)Alanine transaminase(ALT) and glutamic-oxalacetic transaminase(AST)is less than 3 times normal range,and total bilirubin is less than 2 milligram per deciliter(TBil≤2.0mg/dL). 7. After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk. 8. Volunteered for this clinical trail and signed a consent form . Exclusion Criteria: 1. Patients with high tumor burden or progression of disease need to control the progression of disease in order to decrease the tumor burden. 2. Patients with active infection and fever. 3. Patients' neutrophilic granulocyte has decreased more than 10 days,and is difficult to control after treatment. 4. Patients are infected with fungus,bacteria or virus,and are difficult to control after treatment. 5. Patients with infection of HIV or with actively infection of Hepatitis B Virus(HBV) or Hepatitis C Virus(HCV). 6. Pregnant or lactating women. 7. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions. 8. Patients had been treated with cell therapy but was invalid.After analyzing the patient's condition , the expert group think that the patient doesn't fit to attend the therapy of CART. 9. The monoclonal antibodies of BCMA or CD38 are invalid for the patients who have used the drug. 10. Any situation may do harm to the subjects or interfere the results. 11. After allogeneic transplantation, patients are more than 3 degrees of acute Graft-Versus-Host disease(GVHD).
References
Publications (0)
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