Tests EB103 T-cell therapy in adults with relapsed B-cell non-Hodgkin lymphoma

Trial details

Who runs it

Estrella Immunopharma, Inc.

Trial code

NCT06343311

Record updated

1 October 2026

Original description

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 full original descriptionShow less

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.

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 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; 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.

Exclusion: Prior CD19-targeted cellular therapy; Those with PCNSL or secondary CNS lymphoma who have previously received whole brain radiotherapy (WBRT); 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; History of Richter's transformation of chronic lymphocytic leukemia (CLL); 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; 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; 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; Autologous HSCT within 3 months of informed consent; 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.

ClinicalTrials.gov NCT06343311