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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04271644
Other study ID # PBC002
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 1, 2019
Est. completion date July 1, 2024

Study information

Verified date March 2023
Source Chongqing Precision Biotech Co., Ltd
Contact Zhi Yang, PhD
Phone 86-13206140093
Email yangzhi@precision-biotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 3 months; 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. Previous history of other malignancy; 2. Presence of uncontrolled active infection; 3. Evidence of disorder that need the treatment by glucocorticoids; 4. Active or chronic GVHD; 5. The patients treatment by inhibitor of T cell; 6. Pregnant or breasting-feeding women; 7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Study Design


Intervention

Biological:
BCMA CAR-T cells
BCMA CAR-T cell therapy

Locations

Country Name City State
China 920th Hospital of Joint Logistics Support Force Kunming Yunnan

Sponsors (1)

Lead Sponsor Collaborator
Chongqing Precision Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events that related to treatment 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) 2 years
Primary The response rate of BCMA CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG 2 years
Secondary Rate of BCMA CAR-T cells in bone marrow and peripheral blood In vivo (bone marrow and peripheral blood) rate of BCMA CAR-T cells were determined by means of flow cytometry 2 years
Secondary Quantity of BCMA CAR copies in bone marrow and peripheral blood In vivo (bone marrow and peripheral blood) quantity of BCMA CAR copies were determined by means of qPCR 2 years
Secondary Quantity of clonal plasma cells in bone marrow In vivo (bone marrow) quantity of clonal plasma cells 1 years
Secondary Levels of Cytokines in Serum In vivo (Serum) quantity of cytokines 1 years
Secondary Duration of Response (DOR) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma 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) 2 years
Secondary Progress-free survival(PFS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored) 2 years
Secondary Overall survival(OS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma OS will be assessed from the first CAR-T cell infusion to death from any cause (censored) 2 years
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