The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or refractory multiple myeloma patients.
This study plans to enroll 10 patients to assess the safety and efficacy of spCART-269. Subjects who meet the eligibility criteria will receive a single dose of spCART-269 injection. The study will include the following sequential phases: Screening, Pre-treatment (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Targeting CD269 chimeric antigen receptor engineered T cells, single infusion intravenously
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGOccurrence of study related adverse events
Incidence and severity of Treatment emergent adverse events
Time frame: 12 weeks
Overall response rate (ORR)
Time frame: 12 months
Duration of remission (DOR)
Time frame: 12 months
Progression free survival (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 weeks, 6 months, 12 months
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