Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Phase 1/2 Trial of TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Acute Lymphoblastic Leukemia (ALL)
Verified date | March 2023 |
Source | TCR2 Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | February 24, 2023 |
Est. primary completion date | February 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Colorado Blood Cancer Institute | Denver | Colorado |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
TCR2 Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | 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 | ||
Primary | 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 |
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