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

Sponsor
TCR2 Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04323657
Collaborator
(none)
120
3
2
48.2
40
0.8

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Mar 27, 2020
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 1

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.

Drug: TC-110 T Cells
TC-110 T Cells

Drug: Fludarabine
Flu/Cy Lymphodepletion

Drug: Cyclophosphamide
Flu/Cy Lymphodepletion

Experimental: Phase 2

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.

Drug: TC-110 T Cells
TC-110 T Cells

Drug: Fludarabine
Flu/Cy Lymphodepletion

Drug: Cyclophosphamide
Flu/Cy Lymphodepletion

Outcome Measures

Primary Outcome Measures

  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). [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) [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 [ORR rate and MRD negativity rate for ALL patients at 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Colorado Blood Cancer Institute Denver Colorado United States 80218
2 Sarah Cannon Research Institute Nashville Tennessee United States 37203
3 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • TCR2 Therapeutics

Investigators

  • Study Chair: Clinical, TCR2 Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TCR2 Therapeutics
ClinicalTrials.gov Identifier:
NCT04323657
Other Study ID Numbers:
  • TCR2-19-01
First Posted:
Mar 26, 2020
Last Update Posted:
Jun 26, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2020