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NCT06420089 · ClinicalTrials.gov registry record · Phase 1
CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)
A Phase 1 study of T Cell Non-Hodgkin Lymphoma, sponsored by Vittoria Biotherapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT06420089: Recruiting Phase 1 study of T Cell Non-Hodgkin Lymphoma, sponsored by Vittoria Biotherapeutics.
NCT06420089 is a Phase 1 study of T Cell Non-Hodgkin Lymphoma that is actively recruiting participants, run by Vittoria Biotherapeutics. The registered enrollment target is 30 participants, below the 44-participant average among 5 other T Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (32% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06420089, a Phase 1 study of T Cell Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Vittoria Biotherapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined.
Primary Outcome
Measure the occurrence of Dose Limiting Toxicity events of each dose level per arm
Conditions Studied
Interventions
- DRUG Senza5 CART5
Study Locations (2)
New York
- Columbia University Irving Medical Center - New York
Pennsylvania
- University of Pennsylvania - Abramson Caner Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-10-04 |
| Est. Completion | 2029-08-30 |
| Phase | Phase 1 |
What NCT06420089 shows while recruiting
NCT06420089 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 44-participant average among 5 other T Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (32% lower).
The record links to 1 condition, with T Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Senza5 CART5 is the first listed.
NCT06420089 reports a single indexed study location in New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06420089 about?
NCT06420089 is a clinical study titled "CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)". This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cell...
What is the current status of trial NCT06420089?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-10-04. Estimated completion is 2029-08-30.
What conditions does trial NCT06420089 study?
This clinical trial studies the following conditions: T Cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT06420089?
The interventions under investigation include: Senza5 CART5 (DRUG).
Who is sponsoring clinical trial NCT06420089?
This trial is sponsored by Vittoria Biotherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06420089 being conducted?
This trial has 2 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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