NCT06343311 T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
| NCT ID | NCT06343311 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Estrella Biopharma, Inc. |
| Condition | B-Cell Non-Hodgkin's Lymphoma (NHL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 21 participants in total. It began in 2024-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Pei Wang, PhD
STUDY DIRECTOR
Eureka Therapeutics Inc.
Frequently Asked Questions
Who can join the NCT06343311 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying B-Cell Non-Hodgkin's Lymphoma (NHL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06343311 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06343311 currently recruiting?
Yes, NCT06343311 is actively recruiting participants. Contact the research team at teresa.klask@eurekainc.com for enrollment information.
Where is the NCT06343311 trial being conducted?
This trial is being conducted at Sacramento, United States, Dallas, United States.
Who is sponsoring the NCT06343311 clinical trial?
NCT06343311 is sponsored by Estrella Biopharma, Inc.. The principal investigator is Pei Wang, PhD at Eureka Therapeutics Inc.. The trial plans to enroll 21 participants.