A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).

NCT07784101 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-08-25

No results posted yet for this study

Summary

This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).

Conditions

  • Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Interventions

DRUG

ICP-248

Administered orally

DRUG

Pirtobrutinib

Administered orally

DRUG

Orelabrutinib

Administered orally

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2032-10-31
Completion
2033-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784101 on ClinicalTrials.gov