Study of BCMA CAR-T in Multiple Myeloma

Phase 1

• Conditions: Multiple Myeloma
• Interventions: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: BCMA CAR-T

• Registration Number: NCT03322735
• Lead Sponsor: Henan Cancer Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Study Start: 2017-12-08
• Last Update Submitted: 2017-12-28
• Last Update Posted: 2017-12-29
• Primary Completion: 2018-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-tumor response of BCMA CAR-T	BCMA CAR-T	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.
anti-tumor response of BCMA CAR-T	Fludarabine	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.
anti-tumor response of BCMA CAR-T	Cyclophosphamide	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	1 year	number of participants with adverse events

Secondary Outcome Measures

Name	Time	Method
Persistence of the BCMA CAR+ T cells	1 year	determine duration of in vivo survival of BCMA CAR-T cells
anti-tumor responses of BCMA CAR-T cells	1 year

Trial Locations

Locations (1)

Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China