Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04272151
• Other study ID #: PBC015
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 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
• 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: 40
• 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 12 weeks;

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. Have received CAR-T therapy or other genetically modified cell therapy before screening;

2. Participated in other clinical research within 1 month before screening;

3. Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;

4. Live attenuated vaccine within 4 weeks before screening;

5. Convulsion or stoke within past 6 months;

6. Previous history of other malignancy;

7. Presence of uncontrolled active infection;

8. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;

9. Pregnant or breasting-feeding women;

10. Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Neoplasm, Plasma Cell
• Neoplasms, Plasma Cell

Intervention

Biological:
• BCMA CAR-T cells
A single infusion of BCMA CAR-T cells will be administered intravenously.

Locations

Country	Name	City	State
China	Chongqing University Cancer Hospital	Chongqing	Chongqing

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	6 months
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 IL-6 in Serum	In vivo (Serum) quantity of IL-6	3 months
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