Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Chimeric Antigen Receptor T cells
Advanced Cellular Therapeutics Facility, DCAM 0800A
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)
Time frame: 24 months
Establish the RP2D of the investigational agent
Time frame: 24 months
Best overall response (BOR) by International Myeloma Working Group (IMWG) Consensus Criteria
Time frame: 24 months
Overall Response Rate (ORR) by IMWG Consensus Criteria
Time frame: 24 months
PK Parameter for Anitocabtagene-Autoleucel: Cmax
Cmax is defined as the maximum observed concentration of drug.
Time frame: Day 1 up to 24 months
PK Parameter for Anitocabtagene-autoleucel: Tmax
Tmax is defined as the time (observed time point) of Cmax.
Time frame: Day 1 up to 24 months
PK Parameter for Anitocabtagene-Autoleucel: Area under the curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Time frame: Day 1 up to 24 months
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