Non Hodgkin Lymphoma Clinical Trial
TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
Summary
TC-110 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human CD19, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.
This is a Phase 1/2 open-label study to evaluate the safety of autologous genetically engineered TC-110 T cells in patients with aggressive NHL (DLBCL, PMBCL, TFL), high-risk indolent NHL (including MCL), or adult ALL.
Eligibility Criteria
Inclusion Criteria:
Patient is > 18 years of age at the time the Informed Consent is signed
Patient has agreed to abide by all protocol-required procedures, including study-related assessments, and management by the treating institution for the duration of the study and LTFU
Histologically confirmed NHL or ALL
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol
Patient must be fit for leukapheresis and have adequate venous access for cell collection
Patient must have evidence of CD19 expression
Prior CD19-directed CAR T therapy is allowed
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There are 3 Locations for this study
Denver Colorado, 80218, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
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