ClinicalTrials.gg
RecruitingNCT06343311STARLIGHT-1Updated Oct 1, 2026

T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

A Phase 1/2 interventional study of EB103 in B-Cell Non-Hodgkin's Lymphoma (NHL), Lymphoma, Non-Hodgkins and Lymphomas Non-Hodgkin's B-Cell, sponsored by Estrella Immunopharma, Inc.. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Estrella Immunopharma, Inc. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Updated Oct 1, 2026Primary completion movedStudy completion moved+5 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 398 studies in Lymphoma, B-Cell with a site in United States — 91 open to participants now, 159 under way, 12 of them phase 3. Lymphoma, B-Cell · United States.

Planned enrollment
230th of 380
27 · median 37
Started
2024
with 18 others
Phase 1/2
75 of 398
20 open now
Primary completion
2027-07
later than 70 of 158 live
Registered
351st of 398
by date

Among the 398 studies in Lymphoma, B-Cell with a site in United States, this one is the 230th largest by planned enrollment of the 380 interventional ones, is one of 19 that started in 2024, is one of 75 in phase 1/2, reaches primary completion later than 70 of the 158 other live ones, and was the 351st registered.

By phase

398 studies; the count open now beside each. This study's row is marked.

Phase 1161 · 34 open
Phase 2112 · 23 open
Phase 1/2this study75 · 20 open
Phase 322 · 4 open
Observational17 · 6 open
No phase8 · 4 open
Other kind1 · 0 open
Phase 2/31 · 0 open
Phase 41 · 0 open

By the year they started

First in 1991; this study’s year is marked. 19 started in 2024.

Size and results

Median enrollment 37 across the 380 interventional studies, 150 across the 17 observational. Of the 216 that completed or were terminated, 110 (51%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 398 studies in Lymphoma, B-Cell with a site in United States, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • 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
  • Lymphoma, Non-Hodgkin's, Adult
  • Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Relapsed Non-Hodgkin Lymphoma
  • Lymphoma, Non-Hodgkin
  • HIV Associated Lymphoma
  • CNS Lymphoma
  • High-grade B-cell Lymphoma
  • Refractory B-Cell Non-Hodgkin 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
  • CNS Lymphoma
  • High-grade B-cell Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
04

Who can participate

The criteria were revised on the registry on Oct 1, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older at the time of
  • confirmed R/R B-cell non-Hodgkin's lymphoma (NHL)
  • Adequate organ function
  • disease

    1. 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 chemoimmunotherapy or to ≥ 2 cycles of later-line chemoimmunotherapy
      • Relapse ≤ 12 months of first-line chemoimmunotherapy
    2. 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 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

    1. For Non-CNS B-cell NHL Positron emission tomography (PET)-positive disease assessment according to Cheson 2014
    2. 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.
  • (ECOG) ≤ 2
  • Toxicities due to prior therapy must be stable and recovered to Grade 1 or less
  • Female subjects of must have a negative serum pregnancy test within 7 days of informed consent and prior to starting conditioning chemotherapy.

Exclusion criteria

Exclusion Criteria:

  • Prior CD19-targeted cellular therapy
  • History of Richter's transformation of chronic lymphocytic leukemia (CLL)
  • History of another primary that has not been in remission for ≥ 2 years.
  • History or presence of 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
  • Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with , , or are eligible provided their infection is being treated and the viral load is controlled.
  • History of disease resulting in end organ injury or requiring systemic /systemic disease modifying agents within the last 2 years
  • History of severe, immediate 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
  • HSCT within 3 months of informed consent
  • Prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced (GvHD) that requires ongoing treatment with systemic or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening
  • within 3 months prior to planned start of conditioning regimen
  • Inability to adhere to all required for agents and therapies prior to leukapheresis AND prior to starting conditioning chemotherapy
  • Female subjects of 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 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.
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    EB103

    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.

    Biological: EB103

Interventions

  • BiologicalEB103

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years

  2. 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: Time Frame: 16 months

Secondary outcomes

  1. 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.

    Time frame: Time Frame: Up to 2 years

  2. 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.

    Time frame: Time Frame: Up to 2 years

  3. 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.

    Time frame: Time Frame: Up to 2 years

  4. 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.

    Time frame: Time Frame: Up to 2 years

  5. 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.

    Time frame: Time Frame: Up to 2 years

  6. 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.

    Time frame: Time Frame: Up to 2 years

  7. 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.

    Time frame: Time Frame: Up to 2 years

  8. 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.

    Time frame: Time Frame: Up to 2 years

  9. 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.

    Time frame: Time Frame: Up to 2 years

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Jul 2027, 37 months after the start.

Of 94 phase 1/2 interventional studies under Lymphoma, B-Cell, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 55 and three quarters within 96. This study's planned 37 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 1, 2026: primary completion Dec 2026 → Jul 2027 and completion Dec 2027 → Jul 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2024
First posted
Apr 2, 2024
StartActual
Jun 1, 2024
Primary completionEst.
Jul 31, 2027was Dec 2026
CompletionEst.
Jul 31, 2028was Dec 2027
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added
Show 3 added (3 United States)
  • University Hospitals Seidman Cancer Center · Cleveland, United States
  • Oregon Health and Sciences University · Portland, United States
  • Intermountain Health, Canyons Region, LDS Hospital · Salt Lake City, United States
Oct 1, 2026
Primary completion
Dec 31, 2026→Jul 31, 2027
Oct 1, 2026
Study completion
Dec 31, 2027→Jul 31, 2028
Oct 1, 2026
Enrollment
21→27
Oct 1, 2026
Eligibility
2 inclusion criteria edited, 11 added, 7 removed; 2 exclusion criteria edited, 7 added, 1 removed
What changed in the criteria
Inclusion criteria
  • AddedRelapsed or refractory disease
  • EditedRelapsed or refractory (R/R) disease, defined as ONE OR MORE of the following modified SCHOLAR-1 criteria (Crump, 2017):
  • RemovedR/R after ≥ 2 lines of systemic therapy
  • RemovedFor the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R/R after ≥ 1 lines of systemic therapy
  • RemovedDisease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)
  • RemovedFor 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
  • RemovedAll subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:
  • RemovedAnti-CD20 monoclonal antibody AND
  • RemovedAn anthracycline-containing chemotherapy regimen
  • AddedProgressive disease (PD) as best response to any line of chemoimmunotherapy
  • AddedStable disease (SD) or partial response (PR) as best response to ≥ 4 cycles of first-line chemoimmunotherapy or to ≥ 2 cycles of later-line chemoimmunotherapy
  • AddedRelapse ≤ 12 months of first-line chemoimmunotherapy
  • AddedSubjects with PCNSL with following status, if deemed appropriate by the Investigator, can be enrolled:
  • AddedIntolerance of high-dose methotrexate (HD-MTX) induction therapy
  • AddedSubjects ineligible for autologous hematopoietic stem cell transplantation (Auto HSCT) consolidation of HD-MTX-based induction
  • AddedSubjects who have relapsed at any time after Auto HSCT
  • AddedDiagnosis and disease assessment
  • EditedFor Non-CNS B-cell NHL Positron emission tomography (PET)-positive disease assessment according to Cheson 2014
  • AddedFor 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.
  • AddedFemale subjects of childbearing potential must have a negative serum pregnancy test within 7 days of informed consent and prior to starting conditioning chemotherapy.
Exclusion criteria
  • RemovedCNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms
  • AddedClinical or radiological evidence of impending brain herniation or significant mass effect
  • AddedThose with PCNSL or secondary CNS lymphoma who have previously received whole brain radiotherapy (WBRT)
  • EditedSubjects with activeActive cardiac lymphoma involvement which is not responding to treatment
  • EditedSubjects with a priorPrior 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
  • AddedInability to adhere to all required washout periods for agents and therapies prior to leukapheresis AND prior to starting conditioning chemotherapy
  • AddedFemale 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
  • AddedIn 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
  • AddedAll 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
  • AddedAny 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.
Oct 1, 2026
Primary outcomes
2 edited, 2 removed
What changed in the outcomes
  • EditedTo assess the Dose Limiting Toxicitiessafety and tolerability of EB103.Time frame: Time Frame: 28 days → Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years
  • EditedTo determine the Recommended Phase II Dose (RP2D) of EB103. (in Phase 1, Dose Escalation)Time frame: Time Frame: 21 months → Time Frame: 16 months
  • RemovedIncidence rates of Treatment-Emergent Adverse Events of EB103.Time frame: Time Frame: 90 days
  • RemovedIncidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103.Time frame: Time Frame: 90 days
Oct 1, 2026
Secondary outcomes
1 edited
What changed in the outcomes
  • EditedTo 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
Oct 1, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • University of California, Davis · Sacramento, United StatesContact r•••@ucdavis.edu · •••2368→s•••@health.ucdavis.edu · •••7182Contact d•••@ucdavis.edu→d•••@health.ucdavis.edu
Oct 1, 2026
Sponsor
Estrella Biopharma, Inc.→Estrella Immunopharma, Inc.
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    3 sites added
    Show 3 added (3 United States)
    • University Hospitals Seidman Cancer Center · Cleveland, United States
    • Oregon Health and Sciences University · Portland, United States
    • Intermountain Health, Canyons Region, LDS Hospital · Salt Lake City, United States
    Primary completion Dec 31, 2026→Jul 31, 2027
    Study completion Dec 31, 2027→Jul 31, 2028
    Enrollment 21→27
    Eligibility 2 inclusion criteria edited, 11 added, 7 removed; 2 exclusion criteria edited, 7 added, 1 removed
    What changed in the criteria
    Inclusion criteria
    • AddedRelapsed or refractory disease
    • EditedRelapsed or refractory (R/R) disease, defined as ONE OR MORE of the following modified SCHOLAR-1 criteria (Crump, 2017):
    • RemovedR/R after ≥ 2 lines of systemic therapy
    • RemovedFor the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R/R after ≥ 1 lines of systemic therapy
    • RemovedDisease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)
    • RemovedFor 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
    • RemovedAll subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:
    • RemovedAnti-CD20 monoclonal antibody AND
    • RemovedAn anthracycline-containing chemotherapy regimen
    • AddedProgressive disease (PD) as best response to any line of chemoimmunotherapy
    • AddedStable disease (SD) or partial response (PR) as best response to ≥ 4 cycles of first-line chemoimmunotherapy or to ≥ 2 cycles of later-line chemoimmunotherapy
    • AddedRelapse ≤ 12 months of first-line chemoimmunotherapy
    • AddedSubjects with PCNSL with following status, if deemed appropriate by the Investigator, can be enrolled:
    • AddedIntolerance of high-dose methotrexate (HD-MTX) induction therapy
    • AddedSubjects ineligible for autologous hematopoietic stem cell transplantation (Auto HSCT) consolidation of HD-MTX-based induction
    • AddedSubjects who have relapsed at any time after Auto HSCT
    • AddedDiagnosis and disease assessment
    • EditedFor Non-CNS B-cell NHL Positron emission tomography (PET)-positive disease assessment according to Cheson 2014
    • AddedFor 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.
    • AddedFemale subjects of childbearing potential must have a negative serum pregnancy test within 7 days of informed consent and prior to starting conditioning chemotherapy.
    Exclusion criteria
    • RemovedCNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms
    • AddedClinical or radiological evidence of impending brain herniation or significant mass effect
    • AddedThose with PCNSL or secondary CNS lymphoma who have previously received whole brain radiotherapy (WBRT)
    • EditedSubjects with activeActive cardiac lymphoma involvement which is not responding to treatment
    • EditedSubjects with a priorPrior 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
    • AddedInability to adhere to all required washout periods for agents and therapies prior to leukapheresis AND prior to starting conditioning chemotherapy
    • AddedFemale 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
    • AddedIn 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
    • AddedAll 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
    • AddedAny 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.
    Primary outcomes 2 edited, 2 removed
    What changed in the outcomes
    • EditedTo assess the Dose Limiting Toxicitiessafety and tolerability of EB103.Time frame: Time Frame: 28 days → Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years
    • EditedTo determine the Recommended Phase II Dose (RP2D) of EB103. (in Phase 1, Dose Escalation)Time frame: Time Frame: 21 months → Time Frame: 16 months
    • RemovedIncidence rates of Treatment-Emergent Adverse Events of EB103.Time frame: Time Frame: 90 days
    • RemovedIncidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103.Time frame: Time Frame: 90 days
    Secondary outcomes 1 edited
    What changed in the outcomes
    • EditedTo 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
    Sponsor Estrella Biopharma, Inc.→Estrella Immunopharma, Inc.
    Site contacts Changed at 1 site. See the sites
    Show the site
    • University of California, Davis · Sacramento, United StatesContact r•••@ucdavis.edu · •••2368→s•••@health.ucdavis.edu · •••7182Contact d•••@ucdavis.edu→d•••@health.ucdavis.edu
    + 4 other changes: verification date, description, design details and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06343311
Lead sponsor
Estrella Immunopharma, Inc.
Collaborators
Eureka Therapeutics Inc.
Responsible party
Sponsor
First posted
Apr 2, 2024
Start date
Jun 1, 2024
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Oct 1, 2026

Study contacts

Teresa Klask, MBA
Contact
teresa.klask@eurekainc.com
925-949-9314
Pei Wang, PhD
Contact
pei.wang@eurekainc.com
510-654-7045
Pei Wang, PhD
study director · Eureka Therapeutics Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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