Duvelisib + BMS-986345 for Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must be taking: Entecavir

Must not be taking: CYP3A4 inhibitors, CYP3A inducers

Disqualifiers: CNS lymphoma, HIV, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

14 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to find a safe dose and to evaluate the safety and tolerability of the drug BMS-986345, in combination with duvelisib.

Research Team

Hayder Saeed, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

Adults with certain types of lymphoid malignancies, including various T-cell lymphomas and B-cell lymphomas, who have progressed after prior therapies. Participants must be over 18, have a performance status indicating they can carry out daily activities with little or no assistance, and not be pregnant or planning to conceive. They should also have adequate organ function.

Inclusion Criteria

Willingness to avoid pregnancy or fathering children based on the following criteria

I have been diagnosed with a specific type of lymphoma or leukemia.

I am fully active or can carry out light work.

Exclusion Criteria

History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis

I cannot take preventive treatments for pneumocystis or herpes viruses.

I haven't had major heart problems or a heart attack in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation to determine the maximum tolerated dose (MTD) of BMS-986345 in combination with Duvelisib in patients with lymphoid malignancy

Up to 26 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 26 months

Treatment Details

Interventions

• CC-486
• Duvelisib

Trial Overview The trial is testing the safety and optimal dose of BMS-986345 when used in combination with duvelisib for treating specific lymphoid cancers. It aims to determine how well patients tolerate this drug combo.

Participant Groups

Group I: Dose Escalation Experimental Treatment 2 Interventions

Dose escalation to determine the maximum tolerated dose (MTD) of BMS-986345 in combination with Duvelisib in patients with lymphoid malignancy. Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 6 dose levels will be used.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Secura Bio, Inc.

Industry Sponsor

Trials

9

Recruited

200+