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NCT05665530 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Prelude Therapeutics.

Completed
Registry status
Phase 1
Development phase
86
Enrollment target

NCT05665530: Completed Phase 1 study, sponsored by Prelude Therapeutics.

NCT05665530 is a Phase 1 study that has completed, run by Prelude Therapeutics. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05665530, a Phase 1 study, has completed, sponsored by Prelude Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
86 participants
Enrollment target

Study 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 as a monotherapy and in combination with zanubrutinib or venetoclax.

Primary Outcome

Dose limiting toxicities will be evaluated during Cycle 1 depending on the treatment arm and intrapatient ramp-up.

Interventions

  • DRUG Zanubrutinib
  • DRUG Venetoclax
  • DRUG PRT2527

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2023-09-12
Est. Completion 2026-01-21
Phase Phase 1
Prelude Therapeutics

12 total trials

What the finished NCT05665530 record still lists

NCT05665530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).

The record links to 0 conditions, and to 3 interventions - of which Zanubrutinib is the first listed.

NCT05665530 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05665530 about?

NCT05665530 is a clinical study titled "A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R 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 ...

What is the current status of trial NCT05665530?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2023-09-12. Estimated completion is 2026-01-21.

What interventions are being tested in trial NCT05665530?

The interventions under investigation include: Zanubrutinib (DRUG), Venetoclax (DRUG), PRT2527 (DRUG).

Who is sponsoring clinical trial NCT05665530?

This trial is sponsored by Prelude Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05665530's enrollment target sits among peer trials

86 652nd of 2000 higher than 1,345 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05665530, the US trial registry maintained by the National Library of Medicine. NCT05665530 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.