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Universal CAR-T Cells Targeting Multiple Myeloma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06006741
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : October 12, 2023
Sponsor:
Information provided by (Responsible Party):
Shenzhen Geno-Immune Medical Institute

Tracking Information
First Submitted Date  ICMJE August 8, 2023
First Posted Date  ICMJE August 23, 2023
Last Update Posted Date October 12, 2023
Estimated Study Start Date  ICMJE October 31, 2023
Estimated Primary Completion Date September 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2023)		 Percentage of patients with treatment related adverse effect [ Time Frame: 6 months ]
percentage of participants with treatment-related adverse events, as assessed by physical examination, vital signs, standard clinical lab tests.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2023)
  • Anti-tumor activity of the universal 4SCAR-T cells after infusion [ Time Frame: 3 months ]
    CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.
  • Anti-tumor activity of fourth generation universal CAR-T cells in patients with relapsed or refractory MM [ Time Frame: 1 year ]
    Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Universal CAR-T Cells Targeting Multiple Myeloma
Official Title  ICMJE Universal CAR-T Cells for the Treatment of Multiple Myeloma
Brief Summary The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal CAR T cells in the body.
Detailed Description

Multiple myeloma (MM) is a malignancy of the plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (SCT).

CAR-T therapy has proven to be a revolutionary treatment for hematological malignancies, but its manufacture is still limited by the high cost, and a long preparation time that is not conducive to timely treatment of patients. In addition, many MM patients suffer from long-term bone marrow suppression caused by tumor growth or prolonged and intense chemotherapies, resulting in exhaustion, aging and functional defects of autologous T cells, which substantially affect the quality of CAR-T cells and the clinical efficacy. The universal CAR-T cells could overcome many of the above problems.

By using universal type of CAR-T cells, the product can be supplied off-the-shelf without being customized from individual patients. In addition, the immediate availability means that patients under severe bone marrow suppression may get a chance to be treated with CAR-T cells to achieve disease remission. In addition, those patients who suffer from long-term immunosuppression due to tumor microenvironment or myelosuppressive chemotherapy would have the option of treatment with the universal CAR-T cells.

The purpose of this study is to assess the feasibility, safety and efficacy of several 4SCAR designs including BCMA, CD138, CD38 and CD19-specific universal CAR-T products targeting MM. Another goal is to learn more about the function of these universal CAR T cells and their persistency in the patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma in Remission
Intervention  ICMJE Biological: MM-specific universal CAR T cells
Infusion of MM-specific universal CAR T cells
Study Arms  ICMJE Experimental: Universal CART cells to treat MM
Intervention: Biological: MM-specific universal CAR T 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: August 16, 2023)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date September 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT).
  2. Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens.
  3. High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases.
  4. Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year).
  5. Relapsed after prior autologous or allogenic SCT with residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
  6. Residual disease after primary therapy and not eligible for ASCT
  7. Expected survival > 12 weeks• Creatinine < 2.5 mg/dl• ALT (alanine aminotransferase)/AST (aspartate aminotransferase) < 3x normal
  8. Bilirubin < 2.0 mg/dl
  9. Any relapse after prior SCT is eligible regardless of other prior therapy
  10. Adequate venous access for apheresis, and no other contraindications for leukapheresis
  11. Voluntary informed consent is signed

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Uncontrolled active infection
  3. Active hepatitis B or hepatitis C infection
  4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  5. Previous related CAR-T cell therapy
  6. Any uncontrolled active medical disorder that would preclude participation
  7. HIV infection
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: Lung-Ji Chang, PhD 86-0755-8672 5195 c@szgimi.org
Contact: Ying Deng 86-0755-8672 5195 ying.deng@szgimi.org
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06006741
Other Study ID Numbers  ICMJE GIMI-IRB-23003
Has Data Monitoring Committee No
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
Current Responsible Party Shenzhen Geno-Immune Medical Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shenzhen Geno-Immune Medical Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shenzhen Geno-Immune Medical Institute
Verification Date October 2023

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