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T-Cell Therapy (EB103) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

This study is testing a new T-cell therapy called EB103 for adults with B-cell non-Hodgkin's lymphoma (NHL) that has come back or not responded to previous treatments (relapsed/refractory). EB103 uses your own T-cells, which are a type of immune cell, that are specially modified to fight the cancer. The main goal of this study is to understand the safety of EB103 by looking at side effects and abnormal lab results within the first 90 days. You may be eligible if you are 18 or older, have confirmed relapsed/refractory B-cell NHL, and have adequate organ function. This study is currently enrolling about 21 participants.

Study design
This is an open-label, multi-center study with a dose escalation phase followed by an expansion phase. It aims to determine the safest and most effective dose of EB103.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess side effects and lab abnormalities for up to 90 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06343311

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Estrella Biopharma, Inc.
~21 participants
Updated 2025-08-07 on ClinicalTrials.gov
What's tested:EB103

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the Dose Limiting Toxicities of EB103.
Measured over Time Frame: 28 days
+3 more outcomes measured

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
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

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B-Cell Non-Hodgkin Lymphoma

NCT06343311

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor Scott & White Research Institute, Texas Oncology

    Dallas, Texasstudy coordinator listed

    Recruiting

  • University of California, Davis

    Sacramento, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pei Wang, PhD · STUDY_DIRECTOR · Eureka Therapeutics Inc.

Who to contact

Teresa Klask, MBA
[email protected]
925-949-9314
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • To assess the Dose Limiting Toxicities of EB103.Time Frame: 28 days

    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.

  • Incidence rates of Treatment-Emergent Adverse Events of EB103.Time Frame: 90 days

    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.

  • Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103.Time Frame: 90 days

    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.

  • To determine the Recommended Phase II Dose (RP2D) of EB103.Time Frame: 21 months

    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.