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

Sponsor
Asclepius Technology Company Group (Suzhou) Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03940833
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: BCMA CAR-NK 92 cells
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
Anticipated Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Biological: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Hematology, Wuxi People's Hospital, Nanjing Medical University Wuxi Jiangsu China 214000

Sponsors and Collaborators

  • Asclepius Technology Company Group (Suzhou) Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asclepius Technology Company Group (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03940833
Other Study ID Numbers:
  • AsclepiusTCG02
First Posted:
May 7, 2019
Last Update Posted:
May 7, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma

Study Results

No Results Posted as of May 7, 2019