Phase 1b2 Study of KRT-232 Combined With Acalabrutinib to Treat Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Chronic Lymphocytic Leukemia

What this Trial Is About

Researchers are evaluating KRT-232, an oral MDM2 inhibitor, combined with acalabrutinib, a BTK inhibitor, for adults with relapsed or refractory Diffuse Large B-Cell Lymphoma DLBCL or Chronic Lymphocytic Leukemia CLL who have not responded to previous treatments. This open-label, multicenter study includes patients with specific genetic profiles TP53 wild-type and aims to assess safety and efficacy in these populations. Participants receive KRT-232 orally once daily for the first 7 days of a 28-day cycle, along with continuous twice-daily oral doses of acalabrutinib starting on Day 1 of each cycle. The study has two cohorts one for relapsedrefractory DLBCL and one for relapsedrefractory CLL. Treatment continues according to the protocol to determine the maximum tolerated dose and response rates. During the trial, participants undergo clinical assessments including pharmacokinetic evaluations at various time points during the first two cycles. Researchers measure outcomes such as maximum tolerated dose, complete response rates, and overall response rates over periods ranging from 56 days to two years. The study involves regular visits for treatment administration and monitoring, with safety and efficacy carefully tracked throughout the participation period.

Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL