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

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BCMA CAR-NK 92 cells
Sponsored by
Asclepius Technology Company Group (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Hematology, Wuxi People's Hospital, Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-tumor response of BCMA CAR-NK-92

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 5, 2019
Last Updated
May 5, 2019
Sponsor
Asclepius Technology Company Group (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03940833
Brief Title
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
Official Title
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asclepius Technology Company Group (Suzhou) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-tumor response of BCMA CAR-NK-92
Arm Type
Experimental
Arm Description
Patients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells.
Intervention Type
Biological
Intervention Name(s)
BCMA CAR-NK 92 cells
Intervention Description
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
Primary Outcome Measure Information:
Title
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
Description
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years to 80 years, expected survival > 3 months Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease ECOG performance status of 0 - 1 Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN No serious allergic constitution No other serous diseases that conflicts with the clinical program No other cancer history Female participants of reproductive potential must have a negative serum pregnancy test Subjects must have signed written, informed consent Exclusion Criteria: Pregnant or lactating women Uncontrolled active infection, HIV infection, syphilis serology reaction positive Active hepatitis B or hepatitis C infection Recent or current use of glucocorticoid or other immunosuppressor Serious mental disorder With severe cardiac, liver, renal insufficiency, diabetes and other diseases Participate in other clinical research in the past three months Previously treatment with any gene therapy products
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangfu Li
Phone
+86 13615181959
Email
lgf@atcgcell.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xianfeng Feng
Phone
+86 15157190521
Email
fxf@atcgcell.com
Facility Information:
Facility Name
Department of Hematology, Wuxi People's Hospital, Nanjing Medical University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zhou, PhD
Email
13358111962@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34471234
Citation
Ng YY, Du Z, Zhang X, Chng WJ, Wang S. CXCR4 and anti-BCMA CAR co-modified natural killer cells suppress multiple myeloma progression in a xenograft mouse model. Cancer Gene Ther. 2022 May;29(5):475-483. doi: 10.1038/s41417-021-00365-x. Epub 2021 Sep 1.
Results Reference
derived

Learn more about this trial

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

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