A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Universal BCMA-targeted LUCAR-B68 Cells Product in Patients With Relapsed/Refractory Multiple Myeloma
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 LUCAR-B68 cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Before treatment with LUCAR-B68 cells, subjects will receive a conditioning regimen
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 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 LUCAR-B68 infusion (Day 1
Dose-limiting toxicity (DLT) rate
Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose
Time frame: Minimum 2 years after LUCAR-B68 infusion (Day 1)
Recommended Phase 2 dose (RP2D) finding
RP2D established through ATD+BOIN design
Time frame: 30 days after LUCAR-B68 infusion (Day 1)
CAR positive NK cells in peripheral blood and bone marrow
CAR positive NK cells in peripheral blood and bone marrow after LUCAR-B68 infusion
Time frame: Minimum 2 years after LUCAR-B68 infusion (Day 1)
CAR transgene levels in peripheral blood
CAR transgene levels in peripheral blood after LUCAR-B68 infusion
Time frame: Minimum 2 years after LUCAR-B68 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 LUCAR-B68 infusion (Day 1)
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Duration of Response (DOR)
Duration of response (DOR) will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria or death due to any cause, whichever occurs first
Time frame: Minimum 2 years after LUCAR-B68 infusion (Day 1)
Time to Response (TTR)
Time to response (TTR) is defined as the time between date of the initial infusion of LCAR-B38M CAR-T cells and the first efficacy evaluation that the participant has met all criteria for PR or better
Time frame: Minimum 2 years after LUCAR-B68 infusion (Day 1)
Progress Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LUCAR-B68 to the first documented disease progression (according to IMWG criteria) or death (due to any cause), whichever occurs first
Time frame: 2 years after LUCAR-B68 infusion (Day 1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LUCAR-B68 to death of the subject
Time frame: Minimum 2 years after LUCAR-B68 infusion (Day 1)
Incidence of anti- LUCAR-B68 antibody
Venous blood samples will be collected to measure LUCAR-B68 positive cell concentrations and the transgenic level of LUCAR-B68, at the time points when anti- LUCAR-B68 antibody serum samples are evaluated
Time frame: Minimum 2 years after LUCAR-B68 infusion (Day 1)