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

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

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

Conditions16

Locations2 sites

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