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NCT06197672 · ClinicalTrials.gov registry record · Phase 1
Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Huda Salman.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT06197672: Recruiting Phase 1 study of Acute Myeloid Leukemia, sponsored by Huda Salman.
NCT06197672 is a Phase 1 study of Acute Myeloid Leukemia that is actively recruiting participants, run by Huda Salman. The registered enrollment target is 30 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (74% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06197672, a Phase 1 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Huda Salman.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory AML. The study will evaluate safety in this patient population and also the presence of efficacy signal described by elimination of residual disease to qualify patients for stem cell transplant.
Primary Outcome
In this traditional phase 1 dose escalation, cohorts of three subjects will be treated on a dose level that will be incremented to next dose level if no dose limiting toxicities (DLT) were reported or expanded if a DLT is documented.
Conditions Studied
Interventions
- BIOLOGICAL CD4CAR
Study Locations (4)
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
- Riley Hospital for Children - Indianapolis
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-03-19 |
| Est. Completion | 2042-12-31 |
| Phase | Phase 1 |
What NCT06197672 shows while recruiting
NCT06197672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which CD4CAR is the first listed.
NCT06197672 reports a single indexed study location in Indiana, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT06197672 about?
NCT06197672 is a clinical study titled "Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant". This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory AML. The study will evaluate safety in this patient population and also the presence of efficacy signal de...
What is the current status of trial NCT06197672?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-03-19. Estimated completion is 2042-12-31.
What conditions does trial NCT06197672 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT06197672?
The interventions under investigation include: CD4CAR (BIOLOGICAL).
Who is sponsoring clinical trial NCT06197672?
This trial is sponsored by Huda Salman, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06197672 being conducted?
This trial has 4 study locations across Florida, Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06197672's enrollment target sits among peer trials
30 204th of 306 higher than 97 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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