a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma

Sponsor

Chongqing Precision Biotech Co., Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04776330

Collaborator

(none)

Enrollment

Location

Arm

27.8

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Neoplasm, Plasma Cell Multiple Myeloma in Relapse	Biological: BCMA targeted prime CAR-T cells	Phase 1/Phase 2

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 prime 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory Multiple Myeloma

Actual Study Start Date :

Mar 7, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BCMA targeted prime CAR-T cells treat Patients will be be treated with BCMA targeted prime CAR-T cells	Biological: BCMA targeted prime CAR-T cells BCMA targeted prime CAR-T cell therapy

Arm

Intervention/Treatment

Experimental: BCMA targeted prime CAR-T cells treat

Patients will be be treated with BCMA targeted prime CAR-T cells

Biological: BCMA targeted prime CAR-T cells

BCMA targeted prime CAR-T cell therapy

Outcome Measures

Primary Outcome Measures

Adverse events that related to treatment [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 targeted prime CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA targeted prime CAR-T cells therapy [2 years]
The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG

Secondary Outcome Measures

Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood [2 years]
In vivo (bone marrow and peripheral blood) rate of BCMA targeted prime CAR-T cells were determined by means of flow cytometry
Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood [2 years]
In vivo (bone marrow and peripheral blood) quantity of BCMA targeted prime CAR copies were determined by means of qPCR
Quantity of clonal plasma cells in bone marrow [1 years]
In vivo (bone marrow) quantity of clonal plasma cells
Levels of IL-6 in Serum [1years]
In vivo (Serum) quantity of IL-6
Duration of Response (DOR) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma [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 targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma [2 years]
PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
Overall survival(OS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma [2 years]
OS will be assessed from the first prime CAR-T cell infusion to death from any cause (censored)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Previous history of other malignancy;
Presence of uncontrolled active infection;
Evidence of disorder that need the treatment by glucocorticoids;
Active or chronic GVHD
The patients treatment by inhibitor of T cell
Pregnant or breasting-feeding women;
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	920th Hospital of Joint Logistics Support Force	Kunming	Yunnan	China

Sponsors and Collaborators

Chongqing Precision Biotech Co., Ltd

Investigators

Principal Investigator: Sanbin Wang, MD, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Principal Investigator: Cheng Qian, PhD, Chongqing University Cancer Hospital