Recruiting

Phase 1

Phase 2

EB103T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

Sponsor:

Estrella Biopharma, Inc.

Code:

NCT06343311

Conditions

B-Cell Non-Hodgkin's Lymphoma (NHL)

Lymphoma, Non-Hodgkins

Lymphomas Non-Hodgkin's B-Cell

Non-Hodgkin Lymphoma

Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EB103

Study Details

Brief 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.

Conditions

B-Cell Non-Hodgkin's Lymphoma (NHL)

Lymphoma, Non-Hodgkins

Lymphomas Non-Hodgkin's B-Cell

Non-Hodgkin Lymphoma

Non-Hodgkin's Lymphoma

Study ID

NCT06343311

Start date

Jun 1, 2024

Status verified date

Aug, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age 18 years or older at the time of informed consent
Histologically confirmed R/R B-cell non-Hodgkin's lymphoma (NHL)
Adequate organ function
Relapsed or refractory (R/R) disease defined as ONE OR MORE of the following:

R/R after ≥ 2 lines of systemic therapy

For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R/R after ≥ 1 lines of systemic therapy
Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)
For subjects who are considered transplant-ineligible: progressive disease as best response after ≥ 4 cycles of first-line therapy and stable disease as best response after ≥ 2 cycles of second-line (salvage) therapy; subject must have received an anti-CD20 monoclonal antibody and an anthracycline as one of their qualifying regimens
All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:

Anti-CD20 monoclonal antibody AND
An anthracycline-containing chemotherapy regimen
Positron emission tomography (PET)-positive disease according to Cheson 2014
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Toxicities due to prior therapy must be stable and recovered to Grade 1 or less

Exclusion Criteria:

Prior CD19-targeted cellular therapy
History of Richter's transformation of chronic lymphocytic leukemia (CLL)
History of another primary malignancy that has not been in remission for ≥ 2 years.
History or presence of clinically relevant Central Nervous System (CNS) pathology
CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms
Subjects with active cardiac lymphoma involvement which is not responding to treatment
History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent
Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents
Venous thrombosis or embolism not managed on a stable regimen of anticoagulation
Autologous HSCT within 3 months of informed consent
Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening
Live vaccine within 3 months prior to planned start of conditioning regimen

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

EB103

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

Primary outcome measure

To assess the Dose Limiting Toxicities of EB103. [ Time Frame: Time Frame: 28 days ]
Incidence rates of Treatment-Emergent Adverse Events of EB103. [ Time Frame: Time Frame: 90 days ]
Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103. [ Time Frame: Time Frame: 90 days ]
To determine the Recommended Phase II Dose (RP2D) of EB103. [ Time Frame: Time Frame: 21 months ]

Central Contacts and Locations

Central contacts

Teresa Klask, MBA

925-949-9314 teresa.klask@eurekainc.com

Pei Wang, PhD

510-654-7045 pei.wang@eurekainc.com

Locations

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Richard "RJ" Joven, CCRP

916-494-2368 rmjoven@ucdavis.edu

Dara Feleciano, RN, MSN

916-475-9904 djfeleciano@ucdavis.edu

Principal Investigator:

Naseem Esteghamat, MD MS

Baylor Scott & White Research Institute, Texas Oncology

Recruiting

Dallas, Texas, United States, 75246

Contacts

Philip Millsap

214-820-7381 corchemebmt@BSWHealth.org

Principal Investigator:

Luis Pineiro, MD

More Information

Sponsor

Estrella Biopharma, Inc.

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Keywords

B-Cell Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
NHL
Lymphoma
Large B-Cell Lymphoma
Refractory Non-Hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
HIV Lymphoma
CNS Lymphoma
High-grade B-cell Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Estrella Biopharma, Inc. on 2025-08-07.