BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

NCT ID: NCT04271644

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2027-07-01

Brief 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.

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.

Conditions

Multiple Myeloma; Neoplasm, Plasma Cell; Multiple Myeloma in Relapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BCMA CAR-T cells treat

Patients will be be treated with BCMA CAR-T cells

Group Type: EXPERIMENTAL

BCMA CAR-T cells

Intervention Type: BIOLOGICAL

BCMA CAR-T cell therapy

Interventions

BCMA CAR-T cells

BCMA CAR-T cell therapy

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Signed written informed consent;

2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing Precision Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanbin Wang, MD

Role: PRINCIPAL_INVESTIGATOR

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Cheng Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhi Yang, PhD

Role: CONTACT

yangzhi@precision-biotech.com

86-13206140093

Facility Contacts

Sanbin Wang, MD

Role: primary

Sanbin1011@163.com

Other Identifiers

PBC002

Identifier Type: -

Identifier Source: org_study_id