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

TCR2 Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Mediastinal Large B Cell Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma; Acute Lymphoblastic Leukemia; Non Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma

Treatments: Drug: Cyclophosphamide; Drug: TC-110 T Cells; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04323657

TCR2-19-01

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Phase 1

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Drug: TC-110 T Cells

Drug: Fludarabine

Phase 2

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Drug: TC-110 T Cells

Drug: Fludarabine