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

Korábbi kezelés

• Prior CD19-targeted cellular therapy
• Those with PCNSL or secondary CNS lymphoma who have previously received whole brain radiotherapy (WBRT)
• 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
• Inability to adhere to all required washout periods for agents and therapies prior to leukapheresis AND prior to starting conditioning chemotherapy
• Female subjects of childbearing potential who are pregnant or breastfeeding; subjects must agree to abstain from breastfeeding during study participation and for ≥ 1 year after lymphodepleting chemotherapy

Más betegség

• History of Richter's transformation of chronic lymphocytic leukemia (CLL)
• 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
• Any medical condition that, in the Investigator's or the Sponsor's opinion, would impose excessive risk to the subject or ability to assess effect of the study drug.

Életkor

• History of another primary malignancy that has not been in remission for ≥ 2 years.

Egyéb

• History or presence of clinically relevant Central Nervous System (CNS) pathology
• Clinical or radiological evidence of impending brain herniation or significant mass effect
• Autologous HSCT within 3 months of informed consent
• In the Investigator's judgement, the subject is unlikely, unable, or unwilling to complete protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
• All genders who are not willing to use acceptable methods of contraception from the time of informed consent through 12 months after EB103 T-cell infusion

• 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 disease
  • Relapsed or refractory disease, defined as ONE OR MORE of the following modified SCHOLAR-1 criteria (Crump, 2017):
  • Progressive disease (PD) as best response to any line of chemoimmunotherapy
  • Stable disease (SD) or partial response (PR) as best response to ≥ 4 cycles of first-line chemoimmunotherapy or to ≥ 2 cycles of later-line chemoimmunotherapy
  • Relapse ≤ 12 months of first-line chemoimmunotherapy
  • Subjects with PCNSL with following status, if deemed appropriate by the Investigator, can be enrolled:
  • Intolerance of high-dose methotrexate (HD-MTX) induction therapy
  • Subjects ineligible for autologous hematopoietic stem cell transplantation (Auto HSCT) consolidation of HD-MTX-based induction
  • Subjects who have relapsed at any time after Auto HSCT
• Diagnosis and disease assessment
  • For Non-CNS B-cell NHL Positron emission tomography (PET)-positive disease assessment according to Cheson 2014
  • For PCNSL or secondary CNS lymphoma shall have the initial diagnosis confirmed by International PCNSL Collaborative Group (IPCG) criteria according to Abrey 2005; Barajas, 2021; Hoang-Xuan 2023.
• Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Toxicities due to prior therapy must be stable and recovered to Grade 1 or less
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days of informed consent and prior to starting conditioning chemotherapy.