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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma in Remission Biological: MM-specific universal CAR T cells Phase 1

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 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: Universal CAR-T Cells for the Treatment of Multiple Myeloma
Estimated Study Start Date : October 31, 2023
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : December 31, 2026

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: Universal CART cells to treat MM Biological: MM-specific universal CAR T cells
Infusion of MM-specific universal CAR T cells


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


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. 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
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): NCT06006741


Contacts
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Contact: Lung-Ji Chang, PhD 86-0755-8672 5195 c@szgimi.org
Contact: Ying Deng 86-0755-8672 5195 ying.deng@szgimi.org

Locations
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China, Guangdong
Shenzhen Geno-Immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-0755-86725195    c@szgimi.org   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
More Information
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Responsible Party: Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT06006741    
Other Study ID Numbers: GIMI-IRB-23003
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: October 12, 2023
Last Verified: October 2023
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
Keywords provided by Shenzhen Geno-Immune Medical Institute:
Universal CART
multiple myelomachimeric antigen BCMA CD38 CD56 CD138 CD19
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