A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies
NCT ID: NCT05665530
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
86 participants
INTERVENTIONAL
2023-09-12
2026-01-21
Brief Summary
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Detailed Description
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Approximately 274 participants will be enrolled in the dose escalation and indication-specific, dose confirmation cohorts.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PRT2527 Monotherapy in Lymphoid Malignancies
PRT2527 will be administered by intravenous infusion once weekly at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication-specific cohorts during the dose confirmation phase.
PRT2527
PRT2527 will be administered by intravenous infusion once weekly.
PRT2527/Zanubrutinib Combination in Lymphoid Malignancies
PRT2527 will be administered by intravenous infusion once weekly at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication specific cohort during the dose confirmation phase.
Zanubrutinib will be administered orally as combination therapy once or twice daily.
PRT2527
PRT2527 will be administered by intravenous infusion once weekly.
Zanubrutinib
Zanubrutinib will be provided in capsules for oral administration once or twice daily.
PRT2527 Monotherapy in Myeloid Malignancies
PRT2527 will be administered by intravenous infusion once weekly at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication-specific cohorts during the dose confirmation phase.
PRT2527
PRT2527 will be administered by intravenous infusion once weekly.
PRT2527/Venetoclax Combination in Myeloid Malignancies
PRT2527 will be administered by intravenous infusion once weekly at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication specific cohort during the dose confirmation phase.
Venetoclax will be administered orally as a combination therapy once daily.
PRT2527
PRT2527 will be administered by intravenous infusion once weekly.
Venetoclax
Venetoclax will be provided in tablet for oral administration once daily
Interventions
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PRT2527
PRT2527 will be administered by intravenous infusion once weekly.
Zanubrutinib
Zanubrutinib will be provided in capsules for oral administration once or twice daily.
Venetoclax
Venetoclax will be provided in tablet for oral administration once daily
Eligibility Criteria
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Inclusion Criteria
* 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%
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Prelude Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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PRT2527-02
Identifier Type: -
Identifier Source: org_study_id
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