T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
STARLIGHT-1
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)
1 other identifier
interventional
27
1 country
5
Brief Summary
This is an open-label, multi-center, Phase 1/2 clinical trial evaluating the safety and effectiveness of EB103 in R/R B-cell NHL patients with the highest unmet medical needs, such as Human Immunodeficiency Virus (HIV)-associated lymphoma, primary and secondary central nervous system (CNS) lymphoma, and a wide range of high-grade B-cell lymphomas (HGBLs), as well as R/R large B-cell lymphoma (LBCL) patients ineligible for autologous transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2024
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2024
CompletedFirst Posted
Study publicly available on registry
April 2, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
October 1, 2026
September 1, 2026
3.2 years
March 14, 2024
September 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess the safety and tolerability of EB103.
Type, frequency, and severity of adverse events (AEs), including treatment-emergent AEs (TEAEs), treatment-related AEs (TRAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), clinically significant laboratory abnormalities recorded as AEs, and AEs leading to permanent discontinuation.
Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years
To determine the Recommended Phase II Dose (RP2D) of EB103 (in Phase 1, Dose Escalation)
RP2D based on maximum tolerated dose (MTD) (if reached), overall safety, preliminary efficacy, and manufacturing capability.
Time Frame: 16 months
Secondary Outcomes (9)
To assess the Overall Response Rate of EB103 in our study subject population.
Time Frame: Up to 2 years
To assess the Disease Control Rate of EB103 in our study subject population.
Time Frame: Up to 2 years
To assess the Duration of Response and duration of complete response of EB103 in our study subject population.
Time Frame: Up to 2 years
To assess the Progression-Free Survival rate of EB103 in our study subject population.
Time Frame: Up to 2 years
To assess the Event-Free Survival rate of EB103 in our study subject population.
Time Frame: Up to 2 years
- +4 more secondary outcomes
Study Arms (1)
EB103
EXPERIMENTALExperimental: Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm) Dose Escalation Cohort: Participants receive a single infusion of EB103 at one of two predefined dose levels on Day 0 (completed). RP2D Confirmatory Cohort: Participants receive EB103 at the RP2D on Day 0. Expansion Cohort: Participants receive an initial EB103 T-cell infusion at the RP2D on Day 0 followed by a second EB103 T-cell infusion administered according to the protocol-defined schedule.
Interventions
EB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene.
Eligibility Criteria
You may qualify if:
- 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 disease
- Relapsed or refractory disease, defined as ONE OR MORE of the following modified SCHOLAR-1 criteria (Crump, 2017):
- Progressive disease (PD) as best response to any line of chemoimmunotherapy
- Stable disease (SD) or partial response (PR) as best response to ≥ 4 cycles of first-line chemoimmunotherapy or to ≥ 2 cycles of later-line chemoimmunotherapy
- Relapse ≤ 12 months of first-line chemoimmunotherapy
- Subjects with PCNSL with following status, if deemed appropriate by the Investigator, can be enrolled:
- Intolerance of high-dose methotrexate (HD-MTX) induction therapy
- Subjects ineligible for autologous hematopoietic stem cell transplantation (Auto HSCT) consolidation of HD-MTX-based induction
- Subjects who have relapsed at any time after Auto HSCT
- Diagnosis and disease assessment
- For Non-CNS B-cell NHL Positron emission tomography (PET)-positive disease assessment according to Cheson 2014
- For PCNSL or secondary CNS lymphoma shall have the initial diagnosis confirmed by International PCNSL Collaborative Group (IPCG) criteria according to Abrey 2005; Barajas, 2021; Hoang-Xuan 2023.
- +3 more criteria
You may not qualify if:
- 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
- Clinical or radiological evidence of impending brain herniation or significant mass effect
- Those with PCNSL or secondary CNS lymphoma who have previously received whole brain radiotherapy (WBRT)
- 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
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eureka Therapeutics Inc.collaborator
- Estrella Immunopharma, Inc.lead
Study Sites (5)
University of California, Davis
Sacramento, California, 95817, United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
Baylor Scott & White Research Institute, Texas Oncology
Dallas, Texas, 75246, United States
Intermountain Health, Canyons Region, LDS Hospital
Salt Lake City, Utah, 84143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pei Wang, PhD
Eureka Therapeutics Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2024
First Posted
April 2, 2024
Study Start
June 1, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2028
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share