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 — BIOLOGICAL
    EB103 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: EB103
    Approximately 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

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817
Richard "RJ" Joven, CCRP
916-494-2368
Dara Feleciano, RN, MSN
916-475-9904
Naseem Esteghamat, MD MS (PRINCIPAL_INVESTIGATOR)
Mehrdad Abedi, MD (SUB_INVESTIGATOR)
Baylor Scott & White Research Institute, Texas OncologyDallasTexas75246
Philip Millsap
214-820-7381
Luis Pineiro, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

Related Studies