TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
NCT ID: NCT04323657
Last Updated: 2023-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
6 participants
INTERVENTIONAL
2020-03-27
2023-02-24
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
TC-110 T Cells
TC-110 T Cells
Fludarabine
Flu/Cy Lymphodepletion
Cyclophosphamide
Flu/Cy Lymphodepletion
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.
TC-110 T Cells
TC-110 T Cells
Fludarabine
Flu/Cy Lymphodepletion
Cyclophosphamide
Flu/Cy Lymphodepletion
Interventions
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TC-110 T Cells
TC-110 T Cells
Fludarabine
Flu/Cy Lymphodepletion
Cyclophosphamide
Flu/Cy Lymphodepletion
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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TCR2 Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical
Role: STUDY_CHAIR
TCR2 Therapeutics
Locations
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Colorado Blood Cancer Institute
Denver, Colorado, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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TCR2-19-01
Identifier Type: -
Identifier Source: org_study_id
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