The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0005
Birmingham, Alabama, United States
Local Institution - 0016
Duarte, California, United States
Local Institution - 0007
Boston, Massachusetts, United States
Local Institution - 0026
Hackensack, New Jersey, United States
Number of participants with adverse events (AEs)
Time frame: Up to 2 years after BMS-986403 infusion
Number of participants with serious adverse events (SAEs)
Time frame: Up to 2 years after BMS-986403 infusion
Number of participants with clinical laboratory abnormalities
Time frame: Up to 2 years after BMS-986403 infusion
Number of participants with dose-limiting toxicity (DLT)
Time frame: Up to 2 years after BMS-986403 infusion
Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period
Time frame: Up to 2 years after BMS-986403 infusion
Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period
Time frame: Up to 2 years after BMS-986403 infusion
Overall response rate (ORR)
Time frame: Up to 2 years after BMS-986403 infusion
Complete remission rate (CRR)
Time frame: Up to 2 years after BMS-986403 infusion
Duration of response (DOR)
Time frame: Up to 2 years after BMS-986403 infusion
Duration of complete remission (DOCR)
Time frame: Up to 2 years after BMS-986403 infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 0009
Columbus, Ohio, United States
Local Institution - 0002
Seattle, Washington, United States
Local Institution - 0024
Barcelona, Spain
Local Institution
Madrid, Spain
Local Institution
Salamanca, Spain
Time to response (TTR)
Time frame: Up to 2 years after BMS-986403 infusion
Time to CR (TTCR)
Time frame: Up to 2 years after BMS-986403 infusion
Progression free survival (PFS)
Time frame: Up to 2 years after BMS-986403 infusion
Overall survival (OS)
Time frame: Up to 2 years after BMS-986403 infusion
Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax)
Time frame: Up to 2 years after BMS-986403 infusion
Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax)
Time frame: Up to 2 years after BMS-986403 infusion
Pharmacokinetics by PCR: Area under the curve (AUC)
Time frame: Up to 2 years after BMS-986403 infusion