Non Hodgkin Lymphoma Clinical Trial
A Study of PRT2527 in Participants With Relapsed/Refractory Hematologic Malignancies
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.
This is an open-label, multi-center, dose-escalation, Phase 1 study of PRT2527, a CDK9 inhibitor, evaluating participants with select R/R hematologic malignancies including aggressive B-cell lymphoma subtypes, mantle cell lymphoma (MCL), and chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL), including Richter's syndrome. The study will be conducted in two parts, the dose escalation phase and the dose confirmation phase. The dose escalation phase will evaluate escalating doses of PRT2527 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 51 participants will be enrolled in the dose escalation and indication-specific, dose confirmation cohorts.
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 or CLL/SLL, including Richter's syndrome, based on local testing 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%
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 with strong CYP3A4 inhibitors or inducers
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
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There is 1 Location for this study
Bethesda Maryland, 20817, United States
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