Clinical Trials /

TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia

NCT04323657

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
TC-110 T CellsPhase 1
FludarabinePhase 1
CyclophosphamidePhase 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

NameTypeDescriptionInterventions
Phase 1ExperimentalThe 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 2ExperimentalThe 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

March 26, 2020