Clinical trial NCT05244070: A Study to Evaluate the Safety and Tolerability of BMS-986403 in Participants With Relapsed and/or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official title: A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Keywords: BMS-986403
Relapsed and/or Refractory
Small Lymphocytic Lymphoma (CLL)
Chronic Lymphocytic Leukemia (SLL)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and high-risk features must have failed at least 2 lines of prior therapy and participants with CLL or SLL and standard risk features must have failed at least 3 lines of prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure
* Has recovery to Grade ≤ 1 or baseline of any non-hematologic toxicities due to previous therapy, except alopecia (any Grade acceptable) and peripheral neuropathy (Grade ≤ 2 acceptable)

Exclusion Criteria:

* Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, that places the subject at unacceptable risk if they were to participate in the study
* Systemic fungal, bacterial, viral, or other infection that is not controlled
* Active autoimmune disease requiring immunosuppressive therapy
* Progressive deep vein thrombosis or pulmonary embolism requiring treatment, but not yet on a stable anticoagulation regimen

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Number of participants with dose-limiting toxicity (DLT)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period
timeFrame: Up to 2 years after BMS-986403 infusion
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Complete remission rate (CRR)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Duration of response (DOR)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Duration of complete remission (DOCR)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Time to response (TTR)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Time to CR (TTCR)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Progression free survival (PFS)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Overall survival (OS)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax)
timeFrame: Up to 2 years after BMS-986403 infusion
measure: Pharmacokinetics by PCR: Area under the curve (AUC)
timeFrame: Up to 2 years after BMS-986403 infusion
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0005
state: Alabama
city: Duarte
country: United States
facility: Local Institution - 0016
state: California
city: Boston
country: United States
facility: Local Institution - 0007
state: Massachusetts
city: Hackensack
country: United States
facility: Local Institution - 0026
state: New Jersey
city: Columbus
country: United States
facility: Local Institution - 0009
state: Ohio
city: Seattle
country: United States
facility: Local Institution - 0002
state: Washington
city: Barcelona
country: Spain
facility: Local Institution - 0024
city: Madrid
country: Spain
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: