OncoMatch/Clinical Trials/NCT07082686
A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)
Is NCT07082686 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies ICP-248 for relapsed or refractory mantle cell lymphoma (mcl).
Treatment: ICP-248 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 expression
MCL expressing Cyclin D1
Required: CCND1 t(11;14) chromosomal translocation
t (11;14) chromosomal translocation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-CD20-containing therapy
Failure of at least one adequate prior line of anti-CD20-containing therapy
Must have received: BTK inhibitor-containing therapy
Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy
Must have received: last line of therapy
Failure of the last line of therapy
Cannot have received: BCL-2 inhibitor (venetoclax, ABT-199)
Prior use of BCL-2 inhibitors (e.g., venetoclax/ABT-199, etc.)
Cannot have received: allogeneic hematopoietic stem cell transplantation
Prior allogeneic hematopoietic stem cell transplantation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07082686 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BCL-2 inhibitor, allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
Does this trial require CCND1?
Yes, CCND1 expression is a required biomarker for enrollment.
Does this trial require CCND1?
Yes, CCND1 t(11;14) chromosomal translocation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages