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出境医 / 临床实验 / Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM

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

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
Multiple Myeloma Biological: BCMA CAR-NK 92 cells Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
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
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Ages Eligible for Study:   18 Years 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
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Contact: Guangfu Li +86 13615181959 lgf@atcgcell.com
Contact: Xianfeng Feng +86 15157190521 fxf@atcgcell.com

Locations
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China, Jiangsu
Department of Hematology, Wuxi People's Hospital, Nanjing Medical University Recruiting
Wuxi, Jiangsu, China, 214000
Contact: Xin Zhou, PhD       13358111962@qq.com   
Sponsors and Collaborators
Asclepius Technology Company Group (Suzhou) Co., Ltd.
Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
Official Title  ICMJE Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: BCMA CAR-NK 92 cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guangfu Li +86 13615181959 lgf@atcgcell.com
Contact: Xianfeng Feng +86 15157190521 fxf@atcgcell.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940833
Other Study ID Numbers  ICMJE AsclepiusTCG02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Asclepius Technology Company Group (Suzhou) Co., Ltd.
Study Sponsor  ICMJE Asclepius Technology Company Group (Suzhou) Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Asclepius Technology Company Group (Suzhou) Co., Ltd.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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