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NCT05190471 · ClinicalTrials.gov registry record · Phase 1

A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)

A Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, sponsored by Bio-Path Holdings.

Recruiting
Registry status
Phase 1
Development phase
48
Enrollment target
4
Study locations

NCT05190471 is a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory that is actively recruiting participants, run by Bio-Path Holdings. The registered enrollment target is 48 participants, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (16% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT05190471, a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, is actively recruiting participants, sponsored by Bio-Path Holdings.

RECRUITING
Registry status
Phase 1
Development phase
48 participants
Enrollment target
4
Study locations

Study Summary

This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory/relapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemic effects of BP1002 as single agent (dose escalation phase) followed by assessing BP1002 in combination with decitabine (dose expansion phase).

Conditions Studied

Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory

Interventions

  • DRUG BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide
  • DRUG Decitabine (in combination with BP1002)

Study Locations (4)

California

  • Scripps Green Hospital - La Jolla
  • UCLA Medical Center - Los Angeles

New York

  • Weill Cornell Medical College - NewYork-Presbyterian Hospital - New York

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2022-08-16
Est. Completion 2027-09
Phase Phase 1

Sponsor

Bio-Path Holdings

5 total trials

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What the Registry Record Tells You About NCT05190471

The ClinicalTrials.gov registry entry for NCT05190471 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (16% lower). The listed sponsor is Bio-Path Holdings, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Myeloid Leukemia, in Relapse appearing as the primary indexed condition, and to 2 interventions - of which BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide is the first listed.

NCT05190471 reports 4 study locations spanning 3 distinct geographic areas - top geographies include California, New York, Texas.

Frequently Asked Questions

What is clinical trial NCT05190471 about?

NCT05190471 is a clinical study titled "A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)". This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory/relapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemi...

What is the current status of trial NCT05190471?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-08-16. Estimated completion is 2027-09.

What conditions does trial NCT05190471 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory.

What interventions are being tested in trial NCT05190471?

The interventions under investigation include: BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide (DRUG), Decitabine (in combination with BP1002) (DRUG).

Who is sponsoring clinical trial NCT05190471?

This trial is sponsored by Bio-Path Holdings, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05190471 being conducted?

This trial has 4 study locations across California, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.