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

Phase 1

• Conditions: Multiple Myeloma
• Interventions: Biological: BCMA CAR-NK 92 cells

• Registration Number: NCT03940833
• Lead Sponsor: Asclepius Technology Company Group (Suzhou) Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-05
• Study First Submitted: 2019-05-05
• Study First Submitted QC: 2019-05-05
• Last Update Submitted: 2019-05-05
• Study First Posted: 2019-05-07
• Last Update Posted: 2019-05-07
• Primary Completion: 2021-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-tumor response of BCMA CAR-NK-92	BCMA CAR-NK 92 cells	Patients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells.

Primary Outcome Measures

Name	Time	Method
Occurrence of treatment related adverse events as assessed by CTCAE v4.03	1 year	Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.

Trial Locations

Locations (1)

Department of Hematology, Wuxi People's Hospital, Nanjing Medical University; 🇨🇳 Wuxi, Jiangsu, China