Clinical trial NCT04323657: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Diffuse Large B Cell Lymphoma
Primary Mediastinal Large B Cell Lymphoma
Mantle Cell Lymphoma
Follicular Lymphoma
Lead sponsor: TCR2 Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-03-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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).
timeFrame: DLTs within 28 days post-treatment
measure: 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)
timeFrame: ORR at 3 months for NHL patients at 3 months
measure: 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
timeFrame: ORR rate and MRD negativity rate for ALL patients at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: TCR2 Therapeutics
name: Clinical
role: STUDY_CHAIR
References: