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

Part of paid clinical trials in Duarte, California.

Sponsor
Prelude Therapeutics
Study ID
NCT05665530
Phase
PHASE1
Status
Completed

Conditions

  • Acute Myeloid Leukemia (AML)
  • Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
  • Chronic Myelomonocytic Leukemia (CMML)
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • MDS/Myeloproliferative Neoplasm (MPN) Overlap Syndrome
  • Mantle Cell Lymphoma (MCL)
  • Marginal Zone Lymphoma
  • Myelodysplastic Syndrome (MDS)
  • Myeloid Malignancies
  • Richter's Syndrome
  • T-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PRT2527 — DRUG
    PRT2527 will be administered by intravenous infusion once weekly.
  • Zanubrutinib — DRUG
    Zanubrutinib will be provided in capsules for oral administration once or twice daily.
  • Venetoclax — DRUG
    Venetoclax will be provided in tablet for oral administration once daily

Study Details

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 Dates

Start date
Sep 12, 2023
Status verified
Jan 2026
Primary completion
Jun 12, 2025
Completion
Jan 21, 2026

Study Design

Enrollment
86 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Dose limiting toxicity (DLT) of PRT2527 [ Time Frame: Baseline through Day 21, 28, or 35 days. ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
American Oncology Partners of Maryland, PABethesdaMaryland20817-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
University of Virginia Comprehensive Cancer CenterCharlottesvilleVirginia22903-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAAmerican Oncology Partners of Maryland, PA· Bethesda, MDDana-Farber Cancer Institute· Boston, MALaura and Isaac Perlmutter Cancer Center at NYU Langone Health· New York, NYUniversity of Virginia Comprehensive Cancer Center· Charlottesville, VA

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