Study of BCMA CAR-T in Multiple Myeloma

Study Overview
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Brief Summary
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The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.

Official Title
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A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Fludarabine
* Drug: Cyclophosphamide
* Biological: BCMA CAR-T


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 18 years to 70 years, expected survival > 3 months; 2. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry. 3. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease.； 4. ECOG performance status of 0-2; 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; 6. No serious allergic constitution; 7. No other serous diseases that conflicts with the clinical program; 8. No other cancer history; 9. female participants of reproductive potential must have a negative serum pregnancy test; 10. Subjects must have signed written, informed consent. Exclusion Criteria: 1. Pregnant or lactating women; 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive; 3. Active hepatitis B or hepatitis C infection; 4. Recent or current use of glucocorticoid or other immunosuppressor; 5. serious mental disorder; 6. With severe cardiac, liver, renal insufficiency, diabetes and other diseases; 7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-tumor response of BCMA CAR-T<br>Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days. Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy. | Drug: Fludarabine<br>* 25-30mg/m2/day IV for 3 days<br>Drug: Cyclophosphamide<br>* cyclophosphamide 0.6-0.8g/m2/day IV for 2 days<br>Biological: BCMA CAR-T<br>* BCMA CAR-T cells will be administered after completion of the chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | number of participants with adverse events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of the BCMA CAR+ T cells | determine duration of in vivo survival of BCMA CAR-T cells | 1 year | 
| anti-tumor responses of BCMA CAR-T cells |  | 1 year |