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

Recruiting now · Phase 1/Phase 2

Conditions studied: Multiple Myeloma, Neoplasm, Plasma Cell, Multiple Myeloma in Relapse

In brief

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.

Key facts

Study ID

NCT04776330

Run by

Chongqing Precision Biotech Co., Ltd

People needed

80

Starts

2021-03-07

Expected to finish

2027-07-01

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent;
• Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, 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%; 12. 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.

You may not qualify if…

• 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.

Where it is running

• 920th Hospital of Joint Logistics Support Force — Kunming, Yunnan, China (enrolling)

Full record on ClinicalTrials.gov

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