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, 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.
• 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