Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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%

Exclusion Criteria:

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

104

Study ID:

NCT05665530

Recruitment Status:

Recruiting

Sponsor:

Prelude Therapeutics

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There are 24 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States
University of Virginia Comprehensive Cancer Center
Charlottesville Virginia, 22903, United States
Austin Health
Heidelberg Victoria, 3084, Australia
Alfred Health
Melbourne Victoria, 3004, Australia
Monash Health
Melbourne Victoria, 3168, Australia
Linear Clinical Research Ltd
Perth Western Australia, 6009, Australia
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Hopital Henri Mondor
Creteil , 94010, France
Claude Huriez Hospital
Lille , 59000, France
Centre Léon Bérard
Lyon , 69373, France
Institut Curie
Saint-Cloud , 92210, France
Universitatsklinikum Koln, Klinik I fur lnnere Medizin
Koln North Rhine-Westphalia, 50937, Germany
lstituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRST
Meldola FC, 47014, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola
Bologna , 40138, Italy
Ospedale Santa Maria delle Croci - AUSL della Romagna
Ravenna , 48121, Italy
lnje University Busan Paik Hospital
Busan , 47392, Korea, Republic of
Keimyung_University Dongsan Hospital
Daegu , 42601, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Pratia MCM Krakow
Kraków Malopolskie, 30-72, Poland
Ente Ospedaliero Cantonale (EOC) lstituto Oncologico della Svizzera italiana (IOSl)- Ospedale San Giovanni (ORBV)
Bellinzona Ticino, 6500, Switzerland
The Leeds Teaching Hospitals NHS Trust, St James University Hospital
Leeds West Yorkshire, LS9 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

104

Study ID:

NCT05665530

Recruitment Status:

Recruiting

Sponsor:


Prelude Therapeutics

How clear is this clinincal trial information?

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