Trial | NCT04271644  Report issue

Official Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    80
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.
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 Started
Apr 01
2019
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Jul 01
2024
Anticipated
Last Update
Apr 18
2023

Biological BCMA CAR-T cells

BCMA CAR-T cell therapy

BCMA CAR-T cells treat Experimental

Patients will be be treated with BCMA CAR-T cells

Criteria 

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%;
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.
No Results Posted