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

Phase 1

Completed

• Conditions: Non Hodgkin Lymphoma; Acute Lymphoblastic Leukemia; Diffuse Large B Cell Lymphoma; Follicular Lymphoma; Primary Mediastinal Large B Cell Lymphoma; Mantle Cell Lymphoma
• Interventions: Drug: TC-110 T Cells; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT04323657
• Lead Sponsor: TCR2 Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-22
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Study Start: 2020-03-27
• Primary Completion: 2023-02-24
• Study Completion: 2023-02-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 2	TC-110 T Cells	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.
Phase 1	TC-110 T Cells	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.
Phase 1	Cyclophosphamide	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.
Phase 1	Fludarabine	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.
Phase 2	Fludarabine	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.
Phase 2	Cyclophosphamide	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.

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (3)

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States