Description:
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.
Title
- Brief Title: TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
- 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)
Clinical Trial IDs
- ORG STUDY ID:
TCR2-19-01
- NCT ID:
NCT04323657
Conditions
- Non Hodgkin Lymphoma
- Acute Lymphoblastic Leukemia
- Diffuse Large B Cell Lymphoma
- Primary Mediastinal Large B Cell Lymphoma
- Mantle Cell Lymphoma
- Follicular Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
TC-110 T Cells | | Phase 1 |
Fludarabine | | Phase 1 |
Cyclophosphamide | | Phase 1 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Phase 1 | Experimental | The Phase 1 portion of the study will proceed according to a standard 3 + 3 dose escalation schema. Patients will be enrolled into 3 cohorts based on disease: NHL cohort, low tumor burden ALL cohort, and high tumor burden ALL cohort. | - TC-110 T Cells
- Fludarabine
- Cyclophosphamide
|
Phase 2 | Experimental | The phase 2 portion of the study will evaluate the efficacy of TC-110 T cells administered at the RP2D, preceded by a lymphodepleting regimen. | - TC-110 T Cells
- Fludarabine
- Cyclophosphamide
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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). |
Time Frame: | DLTs within 28 days post-treatment |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | TCR2 Therapeutics |
Last Updated
June 26, 2020