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NCT03829540 · ClinicalTrials.gov registry record · Phase 1
CD4CAR for CD4+ Leukemia and Lymphoma
A Phase 1 study of T-Cell Lymphoma and T-cell Leukemia, sponsored by Huda Salman.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 6
- Study locations
NCT03829540: Recruiting Phase 1 study of T-Cell Lymphoma and T-cell Leukemia, sponsored by Huda Salman.
NCT03829540 is a Phase 1 study of T-Cell Lymphoma and T-cell Leukemia that is actively recruiting participants, run by Huda Salman. The registered enrollment target is 20 participants, below the 133-participant average among 15 other T-Cell Lymphoma trials with a reported enrollment target (85% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03829540, a Phase 1 study of T-Cell Lymphoma and T-cell Leukemia, is actively recruiting participants, sponsored by Huda Salman.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study is designed as a single arm open label Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells. Funding Source - FDA OOPD
Primary Outcome
To assess the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD4 lentiviral vector (referred to as "CD4CAR" cells) according to CTCAE grading. The feasibility of treating those adverse events and their duration till resolution will also be described.
Conditions Studied
Interventions
- BIOLOGICAL CD4CAR
Study Locations (6)
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
- Riley Hospital for Children - Indianapolis
New York
- Albert Einstein Health Network - New York
- Stony Brook Cancer Center - Stony Brook
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 | 20 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2041-12 |
| Phase | Phase 1 |
What NCT03829540 shows while recruiting
NCT03829540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 15 other T-Cell Lymphoma trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with T-Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which CD4CAR is the first listed.
NCT03829540 lists 6 locations in 4 states (Indiana, New York, Florida).
Frequently Asked Questions
What is clinical trial NCT03829540 about?
NCT03829540 is a clinical study titled "CD4CAR for CD4+ Leukemia and Lymphoma". This study is designed as a single arm open label Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-c...
What is the current status of trial NCT03829540?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-07-09. Estimated completion is 2041-12.
What conditions does trial NCT03829540 study?
This clinical trial studies the following conditions: T-Cell Lymphoma, T-cell Leukemia.
What interventions are being tested in trial NCT03829540?
The interventions under investigation include: CD4CAR (BIOLOGICAL).
Who is sponsoring clinical trial NCT03829540?
This trial is sponsored by Huda Salman, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03829540 being conducted?
This trial has 6 study locations across Florida, Indiana, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for T-Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03829540's enrollment target sits among peer trials
20 13th of 15 higher than 2 of 15 other T-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other T-Cell Lymphoma 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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