B-Cell Non-Hodgkin's Lymphoma (NHL)Phase 1/2STARLIGHT-1NCT06343311
T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
A Phase 1/2 study testing EB103 in people with B-Cell Non-Hodgkin's Lymphoma (NHL) and Lymphoma, Non-Hodgkins, run by Estrella Immunopharma, Inc. at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Non-Hodgkin's Lymphoma (NHL), Lymphoma, Non-Hodgkins, Lymphomas Non-Hodgkin's B-Cell
- What is being tested?
- EB103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2024to 31 Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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.
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Toxicities due to prior therapy must be stable and recovered to Grade 1 or less
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days of informed consent and prior to starting conditioning chemotherapy.
Who cannot join
- 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)
Show all 20Show fewer
- 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
- Inability to adhere to all required washout periods for agents and therapies prior to leukapheresis AND prior to starting conditioning chemotherapy
- Female subjects of childbearing potential who are pregnant or breastfeeding; subjects must agree to abstain from breastfeeding during study participation and for ≥ 1 year after lymphodepleting chemotherapy
- In the Investigator's judgement, the subject is unlikely, unable, or unwilling to complete protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
- All genders who are not willing to use acceptable methods of contraception from the time of informed consent through 12 months after EB103 T-cell infusion
- Any medical condition that, in the Investigator's or the Sponsor's opinion, would impose excessive risk to the subject or ability to assess effect of the study drug.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106
Magdalen Sheets, RN, BSN, OCN, 216-286-6488, Magdalen.Sheets@UHhospitals.org
Ariel Sindel, DO
- Recruiting
Baylor Scott & White Research Institute, Texas Oncology
Dallas, Texas, 75246
Philip Millsap, 214-820-7381, corchemebmt@BSWHealth.org
Luis Pineiro, MD
- Recruiting
Oregon Health and Sciences University
Portland, Oregon, 97239
Knight Cancer Institute
503-494-1080, trials@ohsu.edu
- Recruiting
University of California, Davis
Sacramento, California, 95817
Sylwia Blawat, DPT, MS, 916-402-7182, sdblawat@health.ucdavis.edu
Dara Feleciano, RN, MSN, 916-475-9904, djfeleciano@health.ucdavis.edu
- Recruiting
Intermountain Health, Canyons Region, LDS Hospital
Salt Lake City, Utah, 84143
Joshua Kunz, 801-408-4712, Joshua.kunz@imail.org
Brad Hunter, MD, MP
About this study
Official title: 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)
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.
Read the detailed description
EB103 is an engineered T-cell therapy built on the ARTEMIS® Cell Receptor Platform.
This study consists of a completed Phase 1 portion and an ongoing Phase 2 expansion portion.
In Phase 1, a traditional 3+3 dose-escalation design was used to evaluate the safety and tolerability of EB103 and to determine the recommended Phase 2 dose (RP2D). Following dose escalation, an RP2D confirmatory cohort was enrolled to further characterize the safety profile of EB103 at the selected dose.
Phase 2 is an expansion cohort in which additional subjects will be enrolled and treated at the RP2D to further evaluate the safety and preliminary efficacy of EB103.
The active assessment period extends for 2 years (24 months) after the EB103 infusion (Day 0). Subjects then enter long-term follow-up (LTFU) for ongoing safety and overall survival assessments through Year 15.
- Conditions
- B-Cell Non-Hodgkin's Lymphoma (NHL), Lymphoma, Non-Hodgkins, Lymphomas Non-Hodgkin's B-Cell, Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Large B-Cell Lymphoma
- Being tested
- EB103
- 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
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Primary Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB103Biological
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 group | Role | What they receive |
|---|---|---|
| EB103 | Experimental | Experimental: 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. Receives: Biological: EB103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time Frame: 16 months
Secondary outcomes (9)
To assess the Overall Response Rate of EB103 in our study subject population.
The Overall Response Rate (ORR), defined as the proportion of subjects with a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) will be assessed.
Measured: Time Frame: Up to 2 years
To assess the Disease Control Rate of EB103 in our study subject population.
The Disease Control Rate (DCR), defined as the proportion of subjects with BOR of either Complete Response (CR), Partial Response (PR), or Stable Disease (SD) will be assessed.
Measured: Time Frame: Up to 2 years
To assess the Duration of Response and duration of complete response of EB103 in our study subject population.
The Duration of Response (DOR), defined as the time from first response to Progressive Disease (PD) or death will be assessed. The duration of complete response (DOCR), defined as the time from CR to PD or death.
Measured: Time Frame: Up to 2 years
To assess the Progression-Free Survival rate of EB103 in our study subject population.
The Progression-Free Survival (PFS), defined as the time from EB103 infusion to PD or death will be assessed.
Measured: Time Frame: Up to 2 years
To assess the Event-Free Survival rate of EB103 in our study subject population.
The Event-Free Survival (EFS) will be defined as the time from EB103 T-cell infusion to the earliest of the following events: death from any cause, PD, or starting a new anticancer therapy.
Measured: Time Frame: Up to 2 years
To assess the Overall Survival rate of EB103 in our study subject population.
The Overall Survival (OS) will be defined as the time from EB103 T-cell infusion to the date of death.
Measured: Time Frame: Up to 2 years
To characterize the pharmacokinetic (PK) profile of EB103 by measuring the peak exposure (Cmax).
The peak exposure (Cmax) will be measured in our study subject population.
Measured: Time Frame: Up to 2 years
To characterize the pharmacokinetic (PK) profile of EB103 by measuring the time to reach peak exposure (Tmax).
Time to reach peak exposure (Tmax) will be measured in our study subject population.
Measured: Time Frame: Up to 2 years
To characterize the pharmacokinetic (PK) profile of EB103 by measuring the partial area under the curve (pAUC).
Partial area under the curve (pAUC) will be measured in our study subject population.
Measured: Time Frame: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Jun 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Non-Hodgkin's Lymphoma (NHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Estrella Immunopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eureka Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Pei Wang, PhD, Study director, Eureka Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343311
- Sponsor's protocol ID
- EBUS22CD19AR100
- Acronym
- STARLIGHT-1
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06343311
- Acronym / sponsor ID
- STARLIGHT-1 / EBUS22CD19AR100
- Conditions
- B-Cell Non-Hodgkin's Lymphoma (NHL), Lymphoma, Non-Hodgkins, Lymphomas Non-Hodgkin's B-Cell, Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Large B-Cell Lymphoma
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Estrella Immunopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eureka Therapeutics Inc.
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
EB103 is an engineered T-cell therapy built on the ARTEMIS® Cell Receptor Platform.
This study consists of a completed Phase 1 portion and an ongoing Phase 2 expansion portion.
In Phase 1, a traditional 3+3 dose-escalation design was used to evaluate the safety and tolerability of EB103 and to determine the recommended Phase 2 dose (RP2D). Following dose escalation, an RP2D confirmatory cohort was enrolled to further characterize the safety profile of EB103 at the selected dose.
Phase 2 is an expansion cohort in which additional subjects will be enrolled and treated at the RP2D to further evaluate the safety and preliminary efficacy of EB103.
The active assessment period extends for 2 years (24 months) after the EB103 infusion (Day 0). Subjects then enter long-term follow-up (LTFU) for ongoing safety and overall survival assessments through Year 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EB103 | Experimental | Biological: EB103Experimental: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- Diagnosis and disease assessment
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EB103EB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene. | Biological | EB103 |
Primary outcome
To assess the safety and tolerability of EB103.
Time frame: Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years
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.
To determine the Recommended Phase II Dose (RP2D) of EB103 (in Phase 1, Dose Escalation)
Time frame: Time Frame: 16 months
RP2D based on maximum tolerated dose (MTD) (if reached), overall safety, preliminary efficacy, and manufacturing capability.
9 secondary outcomes
To assess the Overall Response Rate of EB103 in our study subject population.
Time frame: Time Frame: Up to 2 years
To assess the Disease Control Rate of EB103 in our study subject population.
Time frame: 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: Time Frame: Up to 2 years
To assess the Progression-Free Survival rate of EB103 in our study subject population.
Time frame: Time Frame: Up to 2 years
To assess the Event-Free Survival rate of EB103 in our study subject population.
Time frame: Time Frame: Up to 2 years
To assess the Overall Survival rate of EB103 in our study subject population.
Time frame: Time Frame: Up to 2 years
To characterize the pharmacokinetic (PK) profile of EB103 by measuring the peak exposure (Cmax).
Time frame: Time Frame: Up to 2 years
To characterize the pharmacokinetic (PK) profile of EB103 by measuring the time to reach peak exposure (Tmax).
Time frame: Time Frame: Up to 2 years
To characterize the pharmacokinetic (PK) profile of EB103 by measuring the partial area under the curve (pAUC).
Time frame: Time Frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pei Wang, PhD study director
Eureka Therapeutics Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EB103 in people with B-Cell Non-Hodgkin's Lymphoma (NHL) and Lymphoma, Non-Hodgkins, run by Estrella Immunopharma, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Klask, MBA (925-949-9314, teresa.klask@eurekainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of EB103. (time frame: Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.