Back to resultsTC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
Primary Purpose
Non Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TC-110 T Cells
Fludarabine
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Non Hodgkin Lymphoma
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
Sites / Locations
- Colorado Blood Cancer Institute
- Sarah Cannon Research Institute
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phase 1
Phase 2
Arm 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.
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.
Outcomes
Primary Outcome Measures
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).
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)
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04323657
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2020 (Actual)
Primary Completion Date
February 24, 2023 (Actual)
Study Completion Date
February 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCR2 Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1
Arm Type
Experimental
Arm 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.
Arm Title
Phase 2
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
TC-110 T Cells
Intervention Description
TC-110 T Cells
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Flu/Cy Lymphodepletion
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Flu/Cy Lymphodepletion
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical
Organizational Affiliation
TCR2 Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
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