Study of BCMA CAR-T in Multiple Myeloma

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Collaborator: The Pregene (ShenZhen) Biotechnology Company, Ltd.
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

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;