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

Estrella Biopharma

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, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase.

Full description

This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of EB103 and determine the RP2D in adult subjects (≥ 18 years of age) who have R/R B-cell NHL.

The study will include a dose escalation phase followed by an expansion phase. A traditional dose escalation model (3+3 design) will be used to determine the RP2D, and once determined, the expansion phase will commence. Additional subjects will be enrolled in the expansion phase to further confirm the safety profile of EB103 at the RP2D and evaluate the preliminary efficacy of EB103.

Enrollment: 21 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 (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 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
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 1 patient group

EB103

Other group

Description:

Approximately six (6) subjects will be treated to determine the RP2D. At the designated RP2D, approximately fifteen (15) additional subjects will be treated.

Treatment:

Biological: EB103