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
21
1 country
2
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.
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
Typical duration for phase_1
2 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
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
August 7, 2025
August 1, 2025
2.6 years
March 14, 2024
August 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To assess the Dose Limiting Toxicities of EB103.
The incidence of Dose Limiting Toxicities (DLTs) that occur within 28 days following EB103 T-cell infusion will be assessed. A DLT consists of any adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, concomitant medication, or intercurrent illness that occurs within 28 days following EB103 T-cell infusion and meets specified criteria as outline in the clinical protocol. The type, frequency, and severity of each DLT, AE, and abnormal laboratory value will be documented to assess the safety and tolerability of EB103.
Time Frame: 28 days
Incidence rates of Treatment-Emergent Adverse Events of EB103.
The type, frequency, and severity of Treatment-Emergent Adverse Events (TEAEs) will be assessed and includes an AE that starts any time from initiation of EB103 administration through and including 90 days after EB103 administration. Listing and summaries will be prepared for the following type of events: TEAEs, SAEs, Grade 3 or higher AEs, treatment related AEs (conditioning chemotherapy, protocol-mandated procedures, or EB103), and AEs leading to death. AESIs, including but not limited to acute infusion reaction, CRS, ICANS, prolonged cytopenia, TLS, MAS/HLH, SPM, and hypogammaglobulinemia.
Time Frame: 90 days
Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103.
The type, frequency, and severity after Treatment-Emergent Laboratory Abnormalities will be assessed and includes a laboratory abnormality that, compared to baseline, worsens by at least one grade with 90 days after EB103 administration.
Time Frame: 90 days
To determine the Recommended Phase II Dose (RP2D) of EB103.
The RP2D will be determined by the study Dose Escalation Committee (DEC) and chosen based on the maximum tolerated dose (MTD) but will not exceed the MTD and the maximum administered dose (MAD). The RP2D will also be based on the manufacturing capability.
Time Frame: 21 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 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
OTHERApproximately six (6) subjects will be treated to determine the RP2D. At the designated RP2D, approximately fifteen (15) additional subjects will be treated.
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 (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
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Estrella Biopharma, Inc.lead
- Eureka Therapeutics Inc.collaborator
Study Sites (2)
University of California, Davis
Sacramento, California, 95817, United States
Baylor Scott & White Research Institute, Texas Oncology
Dallas, Texas, 75246, 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
- SEQUENTIAL
- 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)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
August 7, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share