A Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Phase 1

Recruiting

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

• Registration Number: NCT04776330
• Lead Sponsor: Chongqing Precision Biotech Co., Ltd

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.

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 Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Study Start: 2021-03-07
• 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;

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

Name	Time	Method
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
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)
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)
Quantity of clonal plasma cells in bone marrow	1 years	In vivo (bone marrow) quantity of clonal plasma cells
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)

Trial Locations

Locations (1)

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