trialsTrialActive

Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

A phase 1/2 trial of Sonrotoclax in mantle cell lymphoma, run by BeiGene, active and no longer recruiting.

Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma is a phase 1/2 interventional study registered as NCT05471843 by BeiGene, with 125 participants enrolled, started 2022-09-05 and due to reach its primary completion in 2025-07-18. Interventions recorded: BGB-11417. Conditions listed: Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.

Setting

A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Phase

Phase 1/2

Sponsor

BeiGene

Registry

Started

2022-09-05

Reported

2026

Enrolled

125 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

125 enrolled

Part 2: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)primaryresponse endpoint

44.2 vs 58.3 out of 100 had their tumour shrink with Part 2: Sonrotoclax 320 mg (Daily Ramp-up) compared with Part 2: Sonrotoclax 320 mg (Twice-weekly Ramp-up); 14.1 fewer per 100.
On this measure the first group did worse, not better.
Other groups: Part 2: Sonrotoclax 320 mg Total 52.4 of 100.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Part 1: Overall Survival (OS)survival endpoint

Median 11.4 vs 9.5 months with Part 1: Sonrotoclax 160 mg (Daily Ramp-up) compared with Part 1: Sonrotoclax 320 mg (Daily Ramp-up); about 1.9 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Caveats

These results apply to the people the trial enrolled: A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

125 enrolled.

Part 2: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)primary

Part 2: Sonrotoclax 320 mg (Daily Ramp-up)44.2 of 100

n = 43

Part 2: Sonrotoclax 320 mg (Twice-weekly Ramp-up)58.3 of 100

n = 60

Part 2: Sonrotoclax 320 mg Total52.4 of 100

n = 103

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95% CI 29.1 to 60.1; Figures from the ClinicalTrials.gov results section (first posted 2026-09-22), not from a publication · 95% CI 44.9 to 70.9 · 95% CI 42.4 to 62.4

Part 1: Overall Survival (OS)

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95% CI 0.7 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-09-22), not from a publication · 95% CI 0.7 to NA

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Part 2: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)primary	Part 2: Sonrotoclax 320 mg (Daily Ramp-up)	43	44.2%	-	-	link
	Part 2: Sonrotoclax 320 mg (Twice-weekly Ramp-up)	60	58.3%
	Part 2: Sonrotoclax 320 mg Total	103	52.4%
Part 1: Overall Survival (OS)	Part 1: Sonrotoclax 160 mg (Daily Ramp-up)	10	11.4 months	-	-	link
Part 1: Overall Survival (OS)	Part 1: Sonrotoclax 320 mg (Daily Ramp-up)	12	9.5 months	-	-	link

Connected

Similar pages

cancers

Mantle cell lymphoma

technologies

BCL-2 inhibitors Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule BCL-2 inhibitor (second generation)

Sonrotoclax · Beqalzi

companies

BeOne Medicines (formerly BeiGene)