Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Non Hodgkin Lymphoma, Primary Mediastinal Large B Cell Lymphoma
Conditions
Brief 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.
Interventions
DRUGTC-110 T Cells
TC-110 T Cells
DRUGFludarabine
Flu/Cy Lymphodepletion
DRUGCyclophosphamide
Flu/Cy Lymphodepletion
Sponsors
TCR2 Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish the recommended phase 2 dose (RP2D) for the NHL and ALL indications according to the observed adverse events, including potential dose-limiting toxicities (DLT). | DLTs within 28 days post-treatment |
| To evaluate the efficacy of autologous genetically modified TC-110 T cells in adult patients with R/R NHL as determined by overall response rate (ORR) | ORR at 3 months for NHL patients at 3 months |
| To evaluate the efficacy of autologous genetically modified TC-110 T cells in adult patients with R/R ALL as determined by overall response rate and Minimum Residual Disease (MRD) negativity rates | ORR rate and MRD negativity rate for ALL patients at 3 months |
Countries
United States
Outcome results
None listed