T-Cell Therapy for Adults with Relapsed B-Cell Non-Hodgkin's Lymphoma
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 study is testing a new T-cell therapy to see if it can help adults with relapsed B-cell non-Hodgkin's lymphoma feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Estrella Immunopharma, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Sacramento, California and 1 other locations) |
| Trial ID | NCT06343311 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of an autologous T-cell therapy called EB103 in adults with relapsed or refractory B-cell non-Hodgkin's lymphoma. It consists of a dose escalation phase to determine the recommended phase II dose, followed by an expansion phase to further assess safety and preliminary efficacy. Participants will be monitored closely throughout the trial to gather data on the treatment's impact on their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory B-cell non-Hodgkin's lymphoma who have undergone prior systemic therapies.
Not a fit: Patients who have not received prior systemic therapy or those with other types of lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat B-cell non-Hodgkin's lymphoma.
How similar studies have performed: Other studies have shown promise with similar T-cell therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sacramento, California and 1 other locations
- University of California, Davis — Sacramento, California, United States (Recruiting)
- Baylor Scott & White Research Institute, Texas Oncology — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Teresa Klask, MBA
- Email: teresa.klask@eurekainc.com
- Phone: 925-949-9314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.