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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03940833

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

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:Multiple Myeloma
  • Intervention/Treatment: Biological: BCMA CAR-NK 92 cells
  • Phase: Phase 1/Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • 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
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 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 [ Time Frame: 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
  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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
Contacts

Contact: Guangfu Li +86 13615181959 lgf@atcgcell.com

Contact: Xianfeng Feng +86 15157190521 fxf@atcgcell.com

Locations

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

Sponsors and Collaborators

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

More Information
  • Responsible Party: Asclepius Technology Company Group (Suzhou) Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03940833 History of Changes
  • Other Study ID Numbers: AsclepiusTCG02
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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