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

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05244070
• Other study ID #: CA097-001
• Secondary ID: 2021-003274-31
• Status: Terminated
• Phase: Phase 1
• Start date: September 14, 2022
• Est. completion date: May 4, 2023

Study information

• Verified date: July 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma

Intervention

Drug:
• BMS-986403
Specified dose on specified days
• Fludarabine
Specified dose on specified days
• Cyclophosphamide
Specified dose on specified days

Locations

Country	Name	City	State
Spain	Local Institution - 0024	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Salamanca
United States	Local Institution - 0005	Birmingham	Alabama
United States	Local Institution - 0007	Boston	Massachusetts
United States	Local Institution - 0009	Columbus	Ohio
United States	Local Institution - 0016	Duarte	California
United States	Local Institution - 0026	Hackensack	New Jersey
United States	Local Institution - 0002	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)		Up to 2 years after BMS-986403 infusion
Primary	Number of participants with serious adverse events (SAEs)		Up to 2 years after BMS-986403 infusion
Primary	Number of participants with clinical laboratory abnormalities		Up to 2 years after BMS-986403 infusion
Primary	Number of participants with dose-limiting toxicity (DLT)		Up to 2 years after BMS-986403 infusion
Primary	Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period		Up to 2 years after BMS-986403 infusion
Primary	Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period		Up to 2 years after BMS-986403 infusion
Secondary	Overall response rate (ORR)		Up to 2 years after BMS-986403 infusion
Secondary	Complete remission rate (CRR)		Up to 2 years after BMS-986403 infusion
Secondary	Duration of response (DOR)		Up to 2 years after BMS-986403 infusion
Secondary	Duration of complete remission (DOCR)		Up to 2 years after BMS-986403 infusion
Secondary	Time to response (TTR)		Up to 2 years after BMS-986403 infusion
Secondary	Time to CR (TTCR)		Up to 2 years after BMS-986403 infusion
Secondary	Progression free survival (PFS)		Up to 2 years after BMS-986403 infusion
Secondary	Overall survival (OS)		Up to 2 years after BMS-986403 infusion
Secondary	Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax)		Up to 2 years after BMS-986403 infusion
Secondary	Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax)		Up to 2 years after BMS-986403 infusion
Secondary	Pharmacokinetics by PCR: Area under the curve (AUC)		Up to 2 years after BMS-986403 infusion

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting