NCT04323657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2020

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

March 27, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

March 22, 2020

Last Update Submit

March 14, 2023

Conditions

Non Hodgkin LymphomaAcute Lymphoblastic LeukemiaDiffuse Large B Cell LymphomaPrimary Mediastinal Large B Cell LymphomaMantle Cell LymphomaFollicular Lymphoma

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

Study Arms (2)

Phase 1

EXPERIMENTAL

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 CellsDrug: FludarabineDrug: Cyclophosphamide

Phase 2

EXPERIMENTAL

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 CellsDrug: FludarabineDrug: Cyclophosphamide

Interventions

TC-110 T CellsDRUG

TC-110 T Cells

Phase 1Phase 2
FludarabineDRUG

Flu/Cy Lymphodepletion

Phase 1Phase 2
CyclophosphamideDRUG

Flu/Cy Lymphodepletion

Phase 1Phase 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, Follicular

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Clinical

    TCR2 Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2020

First Posted

March 26, 2020

Study Start

March 27, 2020

Primary Completion

February 24, 2023

Study Completion

February 24, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)