Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2022-05-31

Brief Summary

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The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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anti-tumor response of BCMA CAR-NK-92

Patients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells.

Group Type EXPERIMENTAL

BCMA CAR-NK 92 cells

Intervention Type BIOLOGICAL

The subject will be observed for any side effects during this time and all the adverse events will be recorded.

Interventions

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BCMA CAR-NK 92 cells

The subject will be observed for any side effects during this time and all the adverse events will be recorded.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. 18 years to 80 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 - 1
5. Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，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
8. Previously treatment with any gene therapy products

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No