Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

Overview

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

Detailed Description

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Interventions

  • Biological: BCMA CAR-T cells
    • A single infusion of BCMA CAR-T cells will be administered intravenously.

Arms, Groups and Cohorts

  • Experimental: BCMA CAR-T cells treat
    • Patients will be be treated with BCMA CAR-T cells

Clinical Trial Outcome Measures

Primary Measures

  • Adverse events that related to treatment
    • Time Frame: 2 years
    • Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
  • The response rate of BCMA CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy
    • Time Frame: 6 months
    • The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG

Secondary Measures

  • Rate of BCMA CAR-T cells in bone marrow and peripheral blood
    • Time Frame: 2 years
    • In vivo (bone marrow and peripheral blood) rate of BCMA CAR-T cells were determined by means of flow cytometry
  • Quantity of BCMA CAR copies in bone marrow and peripheral blood
    • Time Frame: 2 years
    • In vivo (bone marrow and peripheral blood) quantity of BCMA CAR copies were determined by means of qPCR
  • Quantity of clonal plasma cells in bone marrow
    • Time Frame: 1 years
    • In vivo (bone marrow) quantity of clonal plasma cells
  • Levels of IL-6 in Serum
    • Time Frame: 3 months
    • In vivo (Serum) quantity of IL-6
  • Duration of Response (DOR) of BCMA CAR-T treatment in patients with refractory/relapsed Multiple Myeloma
    • Time Frame: 2 years
    • DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored)
  • Progress-free survival(PFS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma
    • Time Frame: 2 years
    • PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
  • Overall survival(OS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma
    • Time Frame: 2 years
    • OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)

Participating in This Clinical Trial

Inclusion Criteria

1. Signed written informed consent 2. Diagnose as relapsed /refractory multiple myeloma, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory patients ; 3. Relapse after hematopoietic stem cell transplantation; 3. Evidence for cell membrane BCMA expression; 4. All genders, ages: 18 to 75 years; 5. The expect time of survive is above 12 weeks; 6. KPS>60; 7. No serious mental disorders ; 8. Left ventricular ejection fraction ≥50% 9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN; 10. Sufficient renal function defined by creatinine clearance≤2 x ULN; 11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications; 13. Ability and willingness to adhere to the study visit schedule and all protocol requirements. Exclusion Criteria:

1. Have received CAR-T therapy or other genetically modified cell therapy before screening; 2. Participated in other clinical research within 1 month before screening; 3. Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment; 4. Live attenuated vaccine within 4 weeks before screening; 5. Convulsion or stoke within past 6 months; 6. Previous history of other malignancy; 7. Presence of uncontrolled active infection; 8. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive; 9. Pregnant or breasting-feeding women; 10. Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chongqing Precision Biotech Co., Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cheng Qian, PhD, Principal Investigator, Chongqing University Cancer Hospital
    • Ying Xiang, MD, Principal Investigator, Chongqing University Cancer Hospital
  • Overall Contact(s)
    • Zhi Yang, PhD, 86-13206140093, yangzhi@precision-biotech.com

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