T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) (STARLIGHT-1)

Estrella Immunopharma, Inc.

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Lymphoma, Non-Hodgkins

Refractory B-Cell Non-Hodgkin Lymphoma

CNS Lymphoma

Large B-Cell Lymphoma

HIV Associated Lymphoma

Relapsed Non-Hodgkin Lymphoma

High-grade B-cell Lymphoma

Lymphoma, Non-Hodgkin

Non-Hodgkin Lymphoma

Lymphomas Non-Hodgkin's B-Cell

Non-Hodgkin's Lymphoma

B-Cell Non-Hodgkin's Lymphoma (NHL)

Lymphoma

Refractory Non-Hodgkin Lymphoma

Lymphoma, Non-Hodgkin's, Adult

Treatments

Biological: EB103

Study type

Interventional

Funder types

Industry

Identifiers

NCT06343311

EBUS22CD19AR100

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
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 first-line 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 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
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.
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 criteria

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)
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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

EB103

Experimental group

Description:

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.

Treatment:

Biological: EB103

Trial contacts and locations

Central trial contact

Pei Wang, PhD; Teresa Klask, MBA

Data sourced from clinicaltrials.gov

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