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

Phase 1

Recruiting

• Conditions: Multiple Myeloma in Relapse; Neoplasm, Plasma Cell; Multiple Myeloma
• Interventions: Biological: BCMA CAR-T cells

• Registration Number: NCT04271644
• Lead Sponsor: Chongqing Precision Biotech Co., Ltd

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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-12-31
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCMA CAR-T cells treat	BCMA CAR-T cells	Patients will be be treated with BCMA CAR-T cells

Primary Outcome Measures

Name	Time	Method
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 CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy	2 years	The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG

Secondary Outcome Measures

Name	Time	Method
Quantity of clonal plasma cells in bone marrow	1 years	In vivo (bone marrow) quantity of clonal plasma cells
Progress-free survival(PFS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma	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	2 years	OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)
Duration of Response (DOR) of BCMA 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)
Quantity of BCMA CAR copies in bone marrow and peripheral blood	2 years	In vivo (bone marrow and peripheral blood) quantity of BCMA CAR copies were determined by means of qPCR
Levels of Cytokines in Serum	1 years	In vivo (Serum) quantity of cytokines
Rate of BCMA CAR-T cells in bone marrow and peripheral blood	2 years	In vivo (bone marrow and peripheral blood) rate of BCMA CAR-T cells were determined by means of flow cytometry

Trial Locations

Locations (1)

920th Hospital of Joint Logistics Support Force; 🇨🇳 Kunming, Yunnan, China