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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940833
Recruitment Status : Unknown
Verified May 2019 by Asclepius Technology Company Group (Suzhou) Co., Ltd..
Recruitment status was:  Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Asclepius Technology Company Group (Suzhou) Co., Ltd.

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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
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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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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940833


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.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Asclepius Technology Company Group (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03940833    
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases