OncRef

Clinical Trial: NCT05665530

A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Prelude Therapeutics Incorporated
Information Provided By:Prelude Therapeutics Incorporated
Last Update Posted:2026-01-26

Study Overview

Brief Summary

This is a Phase 1 dose-escalation study of PRT2527, a potent and highly selective cyclin-dependent kinase (CDK) 9 inhibitor, in participants with select relapsed or refractory (R/R) hematologic malignancies. The purpose of this study is to evaluate the safety, tolerability, recommended phase 2 dose (PR2D), and preliminary efficacy of PRT2527 as a monotherapy and in combination with zanubrutinib or venetoclax.

Official Title

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With Relapsed/Refractory Hematologic Malignancies

Conditions

Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Richter's Syndrome, T-cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma, Myeloid Malignancies, Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), Myelodysplastic Syndrome (MDS), MDS/Myeloproliferative Neoplasm (MPN) Overlap Syndrome

Intervention / Treatment

  • Drug: PRT2527
  • Drug: Zanubrutinib
  • Drug: Venetoclax

Other Study ID Numbers

  • PRT2527-02

Start Date (Actual)

2023-09-12

Primary Completion Date (Actual)

2025-06-12

Study Completion Date (Actual)

2026-01-21

Enrollment (Actual)

86

Study Type

Interventional

Phase

Phase 1