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NCT07343934 · ClinicalTrials.gov registry record · Phase 1
huCART19-IL18-eDHFR Cells in Relapsed/Refractory Follicular Lymphoma
A Phase 1 study, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT07343934: Recruiting Phase 1 study, sponsored by University of Pennsylvania.
NCT07343934 is a Phase 1 study that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07343934, a Phase 1 study, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a phase 1, open-label study to evaluate the feasibility, safety and preliminary efficacy of huCART19-IL18-eDHFR cells administered in patients with relapsed or refractory follicular lymphoma. This study will be initiated as a single arm study (Treatment Arm A), which will evaluate the use of huCART19-IL18-eDHFR cells without prior lymphodepletion. In this Treatment Arm A, all subjects will receive a single flat dose of 7x10\[6\] huCART19-IL18-eDHFR cells (Dose Level 1; DL1). Additional treatment arms may also be introduced in the future, via subsequent amendment(s). Co-expression of eDHFR within huCART19-IL18 cells will allow the trafficking of the transduced CAR T cells to be visualized by PET/CT imaging using an investigational radiolabeled imaging agent \[18F\]Fluoropropyl-Trimethoprim (also known as \[18F\]FP-TMP). The feasibility of using \[18F\]FP-TMP PET/CT imaging to detect and measure the eDHFR-expressing CAR T cells will be investigated, as well as its ability to provide insight into CAR T cell pharmacokinetics, biodistribution, and persistence.
Interventions
- BIOLOGICAL huCART19-IL18-eDHFR cells
- DRUG [18F]Fluoropropyl-Trimethoprim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2026-05-18 |
| Est. Completion | 2042-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07343934
The ClinicalTrials.gov registry entry for NCT07343934 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which huCART19-IL18-eDHFR cells is the first listed.
NCT07343934 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07343934 about?
NCT07343934 is a clinical study titled "huCART19-IL18-eDHFR Cells in Relapsed/Refractory Follicular Lymphoma". This is a phase 1, open-label study to evaluate the feasibility, safety and preliminary efficacy of huCART19-IL18-eDHFR cells administered in patients with relapsed or refractory follicular lymphoma. This study will be initiated as a single arm study (Treatment Arm A), which will evaluate the use of...
What is the current status of trial NCT07343934?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2026-05-18. Estimated completion is 2042-11.
What interventions are being tested in trial NCT07343934?
The interventions under investigation include: huCART19-IL18-eDHFR cells (BIOLOGICAL), [18F]Fluoropropyl-Trimethoprim (DRUG).
Who is sponsoring clinical trial NCT07343934?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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