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NCT06343311 · ClinicalTrials.gov registry record · Phase 1
T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
A Phase 1 study of Lymphoma and Non-Hodgkin Lymphoma, sponsored by Estrella Biopharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT06343311: Recruiting Phase 1 study of Lymphoma and Non-Hodgkin Lymphoma, sponsored by Estrella Biopharma.
NCT06343311 is a Phase 1 study of Lymphoma and Non-Hodgkin Lymphoma that is actively recruiting participants, run by Estrella Biopharma. The registered enrollment target is 21 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06343311, a Phase 1 study of Lymphoma and Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Estrella Biopharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase.
Primary Outcome
The incidence of Dose Limiting Toxicities (DLTs) that occur within 28 days following EB103 T-cell infusion will be assessed. A DLT consists of any adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, concomitant medication, or intercurrent illness that occurs within 28 days following EB103 T-cell infusion and meets specified criteria as outline in the clinical protocol. The type, frequency, and severity of each DLT, AE, and abnormal laboratory va
Conditions Studied
Interventions
- BIOLOGICAL EB103
Study Locations (2)
California
- University of California, Davis - Sacramento
Texas
- Baylor Scott & White Research Institute, Texas Oncology - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT06343311 shows while recruiting
NCT06343311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (96% lower).
The record links to 10 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which EB103 is the first listed.
NCT06343311 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT06343311 about?
NCT06343311 is a clinical study titled "T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)". This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will inclu...
What is the current status of trial NCT06343311?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2024-06-01. Estimated completion is 2027-12-31.
What conditions does trial NCT06343311 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Large B-cell Lymphoma, Refractory Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT06343311?
The interventions under investigation include: EB103 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06343311?
This trial is sponsored by Estrella Biopharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06343311 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06343311's enrollment target sits among peer trials
21 244th of 299 higher than 55 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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