This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCDR cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Before treatment with LCAR-BCDR cells, subjects will receive a conditioning regimen
Beijing Gobroad Boren Hospital
Beijing, Beijing Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Shanghai Changzheng Hospital
Shanghai, China
Shanghai Fourth People's Hospital Affiliated to Tongji University
Shanghai, China
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Recommended Phase 2 dose (RP2D) finding
RP2D established through ATD+BOIN design
Time frame: 30 days after LCAR-BCDR infusion (Day 1)
CAR positive T cells in peripheral blood and bone marrow
CAR positive T cells in peripheral blood and bone marrow after LCAR-BCDR infusion
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
CAR transgene levels in peripheral blood and bone marrow
CAR transgene levels in peripheral blood and bone marrow after LCAR-BCDR infusion
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Overall Response Rate (ORR)
The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria.
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Progression-free survival (PFS)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-BCDR to the first documented disease progression (according to IMWG criteria) or death (due to any cause), whichever occurs first
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
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Institute of Hematology & Blood Diseases Hospital
Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-AIO to death of the subject
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
Incidence of anti-LCAR-BCDR antibody
Venous blood samples will be collected to measure LCAR-BCDR positive cell concentrations and the transgenic level of LCAR-BCDR, at the time points when anti-LCAR-BCDR antibody serum samples are evaluated
Time frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)