T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
Part of paid clinical trials in Sacramento, California.
- Sponsor
- Estrella Biopharma, Inc.
- Study ID
- NCT06343311
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- B-Cell Non-Hodgkin's Lymphoma (NHL)
- CNS Lymphoma
- HIV Associated Lymphoma
- High-grade B-cell Lymphoma
- Large B-Cell Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Non-Hodgkin's, Adult
- Lymphoma, Non-Hodgkins
- Lymphomas Non-Hodgkin's B-Cell
- Non-Hodgkin Lymphoma
- Non-Hodgkin's Lymphoma
- Refractory B-Cell Non-Hodgkin Lymphoma
- Refractory Non-Hodgkin Lymphoma
- Relapsed Non-Hodgkin Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- EB103 — BIOLOGICALEB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene.
Study Details
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.
Key Dates
- Start date
- Jun 1, 2024
- Status verified
- Aug 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 21 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Other: EB103Approximately six (6) subjects will be treated to determine the RP2D. At the designated RP2D, approximately fifteen (15) additional subjects will be treated.
Primary Outcome Measure
To assess the Dose Limiting Toxicities of EB103. [ Time Frame: Time Frame: 28 days ]
Central Contacts
- Teresa Klask, MBA925-949-9314
- Pei Wang, PhD510-654-7045
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | Naseem Esteghamat, MD MS (PRINCIPAL_INVESTIGATOR) Mehrdad Abedi, MD (SUB_INVESTIGATOR) |
| Baylor Scott & White Research Institute, Texas Oncology | Dallas | Texas | 75246 | Luis Pineiro, MD (PRINCIPAL_INVESTIGATOR) |
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