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

Completed · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT05665530
Run by: Prelude Therapeutics
People needed: 86
Starts: 2023-09-12
Expected to finish: 2026-01-21
Last updated by the study team: 2026-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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, MZL, or CLL/SLL (including Richter's syndrome) based on local testing, or TCL (monotherapy only), AML, CMML, MDS, or MDS/MPN overlap syndrome that have relapsed or become refractory to or be ineligible for standard-of-care therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2.
Adequate organ function (hematology, renal, and hepatic)
Echocardiogram (or multigated acquisition [MUGA] scan) indicating a left ventricular ejection fraction of ≥ 50%

You may not qualify 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
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
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

Where it is running

City of Hope — Duarte, California, United States
American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
University of Virginia Comprehensive Cancer Center — Charlottesville, Virginia, United States
Austin Health — Heidelberg, Victoria, Australia
Alfred Health — Melbourne, Victoria, Australia
Monash Health — Melbourne, Victoria, Australia
Linear Clinical Research Ltd — Perth, Western Australia, Australia
Jewish General Hospital — Montreal, Quebec, Canada
Hopital Henri Mondor — Créteil, France
Claude Huriez Hospital — Lille, France
Centre Léon Bérard — Lyon, France
Institut Curie — Saint-Cloud, France
Universitatsklinikum Koln, Klinik I fur lnnere Medizin — Cologne, North Rhine-Westphalia, Germany
lstituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRST — Meldola, FC, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola — Bologna, Italy
Ospedale Santa Maria delle Croci - AUSL della Romagna — Ravenna, Italy
Pratia MCM Krakow — Krakow, Lesser Poland Voivodeship, Poland
lnje University Busan Paik Hospital — Busan, South Korea
Keimyung_University Dongsan Hospital — Daegu, South Korea
Samsung Medical Center — Seoul, South Korea
Ente Ospedaliero Cantonale (EOC) lstituto Oncologico della Svizzera italiana (IOSl)- Ospedale San Giovanni (ORBV) — Bellinzona, Canton Ticino, Switzerland
The Leeds Teaching Hospitals NHS Trust, St James University Hospital — Leeds, West Yorkshire, United Kingdom

Full record on ClinicalTrials.gov

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