BGB-11417 for Mantle Cell Lymphoma

Recruiting at 129 trial locations

Overseen By BeiGene

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: BeiGene

No Placebo Group

Trial Summary

What is the purpose of this trial?

The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

Eligibility Criteria

This trial is for people with a confirmed diagnosis of mantle cell lymphoma (MCL) who have relapsed or are not responding to treatment. They must have measurable disease, previous treatments including CD20-based therapy and BTK inhibitors, and be in fairly good health based on ECOG status. People can't join if they've had certain recent transplants, active severe infections, cardiovascular issues, prior Bcl-2 inhibitor use like venetoclax, or other cancers within the last 3 years.

Inclusion Criteria

My organs are working well.

My diagnosis of mantle cell lymphoma is confirmed by tissue analysis.

My condition has returned or didn't respond to treatment.

Exclusion Criteria

I have a serious heart condition.

I am currently being treated for a serious infection.

My lymphoma has spread to my brain or spinal cord.

Treatment Details

Interventions

• BGB-11417 (BTK Inhibitor)

Trial Overview The study tests BGB-11417 as a single agent for MCL that's come back or isn't getting better after treatment. It has two parts: first finding the safest dose and then checking how well it works at that dose against MCL.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Participants will receive sonrotoclax

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+