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NCT Number: NCT04323657

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

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.

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Key information

Conditions

Non Hodgkin Lymphoma Acute Lymphoblastic Leukemia Diffuse Large B Cell Lymphoma Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Mediastinal Large B Cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Colorado Blood Cancer Institute, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TC-110 T Cells

Drug

TC-110 T Cells

Fludarabine

Drug

Flu/Cy Lymphodepletion

Cyclophosphamide

Drug

Flu/Cy Lymphodepletion

Primary outcomes

  1. 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

  2. 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)

    Time frame: ORR at 3 months for NHL patients at 3 months

  3. 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

    Time frame: ORR rate and MRD negativity rate for ALL patients at 3 months

Sponsors and collaborators

Lead sponsor

TCR2 Therapeutics

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2020
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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