Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06343311

T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of EB103 T-Cell Therapy in Adults With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (NHL)

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
21 (estimated)
Sponsor
Estrella Biopharma, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of EB103 and determine the RP2D in adult subjects (≥ 18 years of age) who have R/R B-cell NHL. The study will include a dose escalation phase followed by an expansion phase. A traditional dose escalation model (3+3 design) will be used to determine the RP2D, and once determined, the expansion phase will commence. Additional subjects will be enrolled in the expansion phase to further confirm the safety profile of EB103 at the RP2D and evaluate the preliminary efficacy of EB103.

Conditions

Interventions

TypeNameDescription
BIOLOGICALEB103EB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene.

Timeline

Start date
2024-06-01
Primary completion
2026-12-31
Completion
2027-12-31
First posted
2024-04-02
Last updated
2025-08-07

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06343311. Inclusion in this directory is not an endorsement.