A Phase 1b and 2 Study of Roginolisib (IOA-244) Combined With Obinutuzumab Followed by Venetoclax in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) After Progression on Prior Bruton Tyrosine Kinase (BTK) Inhibitors

Summary

This is a Phase 1b and 2, open-label, single-arm study evaluating the safety, tolerability, and efficacy of roginolisib (IOA-244) in combination with obinutuzumab followed by venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have progressed after prior Bruton Tyrosine Kinase (BTK) inhibitor therapy. The study aims to determine the maximum tolerated dose of roginolisib in combination with obinutuzumab, and to assess the rate of undetectable minimal residual disease (uMRD) after sequential therapy with roginolisib, obinutuzumab, and venetoclax.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Roginolisib

  Oral, once daily, 40 mg or 80 mg QD depending on cohort, starting on day 1 of cycle 1 and continuing until cycle 13 or until progression/toxicity.

• Drug
  Obinutuzumab

  Intravenous infusion, administered as per label for 6 cycles (28-day cycles): 100 mg on day 1 cycle 1, 900 mg on day 2 cycle 1, 1000 mg on days 8 and 15 of cycle 1, then 1000 mg on day 1 of cycles 2-6.

• Drug
  Venetoclax

  Oral, once daily, starting at cycle 7 with standard weekly dose escalation (20 mg, 50 mg, 100 mg, 200 mg, 400 mg), then continued for 6-12 months depending on MRD results.

Locations (2)