for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
completion around



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.

Official Title

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


This is an open-label, multi-center, dose-escalation, Phase 1 study of PRT2527, a CDK9 inhibitor, as monotherapy and in combination with zanubrutinib, a Bruton tyrosine kinase inhibitor (BTKi), evaluating participants with select R/R hematologic malignancies including aggressive B-cell lymphoma subtypes, mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), including Richter's syndrome and T-cell lymphoma (TCL) subtypes. The study will be conducted in two parts, the dose escalation phase and the dose confirmation phase for both monotherapy and combination therapy. The dose escalation phase will evaluate escalating doses of PRT2527 as a monotherapy and in combination with zanubrutinib until MTD is identified or when the RP2D is determined. The dose confirmation phase will evaluate indication-specific cohorts at the RP2D to confirm the dose. Approximately 104 participants will be enrolled in the dose escalation and indication-specific, dose confirmation cohorts.


Aggressive B-Cell Non-Hodgkin's Lymphoma, Aggressive B-Cell NHL, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Mantle Cell Lymphoma (MCL), Richter's Syndrome, T-cell Lymphoma, CDK9, CLL/SLL, Cyclin-Dependent Kinase 9, Hematologic Malignancies, PRT2527, Relapse/Refractory, T-cell Lymphoma (TCL), Zanubrutinib, Lymphoma, Neoplasms, Non-Hodgkin Lymphoma, Lymphoid Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Mantle-Cell Lymphoma, Lymphoma, T-Cell, Peripheral, Hematologic Neoplasms, B-Cell Lymphoma, Aggression, PRT2527 Monotherapy


You can join if…

Open to people ages 18 years and up

  • Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
  • Histologically or cytologically confirmed diagnosis of aggressive B-cell lymphoma subtypes, MCL, CLL/SLL, including Richter's syndrome, based on local testing , or TCL (monotherapy only) that have relapsed or become refractory to or be ineligible for standard-of-care therapy
  • Must provide either an archival or fresh tumor tissue sample from a core or excisional/surgical biopsy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ function (hematology, renal, and hepatic)
  • Echocardiogram (or multigated acquisition [MUGA] scan) indicating a left ventricular ejection fraction of ≥ 50%

You CAN'T join if...

  • Have active central nervous system involvement by malignancy, uncontrolled intercurrent illnesses, and active infections requiring systemic therapy
  • Have undergone HSCT within the last 90 days or have graft versus host disease (GvHD) Grade > 1 at study entry
  • Mean corrected QT interval of > 470 msec following triplicate ECG measurements or a history of long QT Syndrome
  • Have severe pulmonary disease with hypoxemia
  • History of another malignancy except for adequately treated non-melanoma skin cancer or lentigo maligna, superficial bladder cancer, and carcinoma in situ of the cervix without evidence of disease, and asymptomatic prostate cancer without known metastatic disease and no requirement for therapy
  • Concurrent treatment or within 15 days of starting study treatment with strong CYP3A4 inhibitors or inducers or use of moderate CYP3A4 inducers (for combination therapy only)
  • Prior exposure to a CDK9 inhibitor
  • Wait at least 5 half-lives of the agent or 14 days after their investigational or approved therapies before start of study treatment, whichever is shorter
  • Mean corrected QT interval of > 470 msec following triplicate ECG measurement or history of long QT syndrome
  • T-Cell leukemias


  • UC San Diego Moores Cancer Center not yet accepting patients
    La Jolla California 92037 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States
  • University of Virginia Comprehensive Cancer Center accepting new patients
    Charlottesville Virginia 22903 United States


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Prelude Therapeutics
Phase 1 research study
Study Type
Expecting 104 study participants
Last Updated