NCT07082686 A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)
| NCT ID | NCT07082686 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
| Condition | Relapsed or Refractory Mantle Cell Lymphoma (MCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-08-21 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2025-08-21 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.
Eligibility Criteria
Inclusion Criteria: * ≥ 18 years old. * Histopathologically confirmed MCL expressing Cyclin D1 and/or t (11;14) chromosomal translocation.Formalin-fixed paraffin-embedded (FFPE) tissues or sections for diagnosis must be provided. It is for the approval of pathological diagnosis by the central pathology laboratory. * The patient was diagnosed with relapsed or refractory mantle cell lymphoma, and the previous treatment needs to meet the following requirements: * Failure of at least one adequate prior line of anti-CD20-containing therapy; * Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy. * Failure of the last line of therapy. * At least one measurable lesion according to the Lugano 2014 criteria,. * ECOG performance status of 0-2 . Exclusion Criteria * Current or prior history of central nervous system (CNS) lymphoma. * Prior use of BCL-2 inhibitors (e.g., venetoclax/ABT-199, etc.). * Autologous stem cell transplantation or cellular therapy within 3 months prior to the first dose of ICP-248. * Prior allogeneic hematopoietic stem cell transplantation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07082686 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed or Refractory Mantle Cell Lymphoma (MCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07082686 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07082686 currently recruiting?
Yes, NCT07082686 is actively recruiting participants. Contact the research team at CO_HGRAC@innocarepharma.com for enrollment information.
Where is the NCT07082686 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Chengdu, China, Chongqing, China and 11 additional locations.
Who is sponsoring the NCT07082686 clinical trial?
NCT07082686 is sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. The trial plans to enroll 75 participants.