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Cyclin-dependent kinase 9 inhibitor

PRT2527 + Zanubrutinib for Blood Cancers

Phase 1
Recruiting
Research Sponsored by Prelude Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through approximately 2 years
Awards & highlights

Study Summary

This trial studies a new drug for cancer treatment to see if it's safe, effective and what the best dose is.

Who is the study for?
This trial is for adults with certain aggressive blood cancers like B-cell lymphoma, mantle cell lymphoma, or chronic leukemia that have stopped responding to standard treatments. Participants must be in good physical condition (ECOG 0 or 1), able to follow the study plan, and have proper organ function. They can't join if they've had recent cancer treatment that conflicts with the study drugs, severe heart issues, lung disease with low oxygen levels, or a history of other cancers except some skin and localized cancers.Check my eligibility
What is being tested?
The trial is testing PRT2527 alone and combined with Zanubrutinib in patients who have relapsed or refractory hematologic malignancies. It's a Phase 1 study focusing on finding the safest dose that works (PR2D) while checking how well these treatments work against these types of blood cancers.See study design
What are the potential side effects?
Possible side effects include those common to cancer therapies such as fatigue, nausea, diarrhea; specific risks related to PRT2527 might involve changes in liver enzymes indicating liver stress. Zanubrutinib may cause bleeding problems, infections due to low white blood cell counts, high blood pressure and second primary malignancies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity (DLT) of PRT2527
Maximum tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT2527 monotherapy and in combination with zanubrutinib
Safety and tolerability of PRT2527 monotherapy and in combination with zanubrutinib: AEs, CTCAE Assessments
Secondary outcome measures
Anti-tumor activity of PRT2527 monotherapy and in combination with zanubrutinib: Duration of response/Complete Response (DOR/DoCR)
Anti-tumor activity of PRT2527 monotherapy and in combination with zanubrutinib: Objective response rate (ORR)
Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib: Area under the curve
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: PRT2527/Zanubrutinib CombinationExperimental Treatment2 Interventions
PRT2527 will be administered by intravenous infusion once weekly on a 35-day treatment cycle for Cycle 1 followed by 21-day treatment for subsequent treatment cycles 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 daily.
Group II: PRT2527 MonotherapyExperimental Treatment1 Intervention
PRT2527 will be administered by intravenous infusion once weekly on a 21-day treatment cycle 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRT2527
2022
Completed Phase 1
~30
Zanubrutinib
2017
Completed Phase 3
~1940

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cyclin-Dependent Kinase (CDK) inhibitors, such as CDK9 inhibitors like PRT2527, function by blocking the activity of CDKs, which are essential for cell cycle progression and transcription regulation. In T-Cell Lymphoma, these inhibitors can stop the proliferation of cancerous cells and induce apoptosis by disrupting the transcription of genes necessary for tumor growth and survival. This mechanism is crucial for patients with relapsed or refractory T-Cell Lymphoma, as it offers a targeted therapeutic strategy to manage the disease.

Find a Location

Who is running the clinical trial?

Prelude TherapeuticsLead Sponsor
8 Previous Clinical Trials
551 Total Patients Enrolled
BeiGeneIndustry Sponsor
177 Previous Clinical Trials
28,956 Total Patients Enrolled

Media Library

PRT2527 (Cyclin-dependent kinase 9 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05665530 — Phase 1
T-Cell Lymphoma Research Study Groups: PRT2527 Monotherapy, PRT2527/Zanubrutinib Combination
T-Cell Lymphoma Clinical Trial 2023: PRT2527 Highlights & Side Effects. Trial Name: NCT05665530 — Phase 1
PRT2527 (Cyclin-dependent kinase 9 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05665530 — Phase 1
~52 spots leftby Apr 2025
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