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

NCT05665530 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-01-26

No results posted yet for this study

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.

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

Interventions

DRUG

PRT2527

PRT2527 will be administered by intravenous infusion once weekly.

DRUG

Zanubrutinib

Zanubrutinib will be provided in capsules for oral administration once or twice daily.

DRUG

Venetoclax

Venetoclax will be provided in tablet for oral administration once daily

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2025-06-12
Completion
2026-01-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • Poland
  • South Korea
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05665530 on ClinicalTrials.gov