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CAR T-cell Therapy

TC-110 T Cells for Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Research Sponsored by TCR2 Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up orr at 3 months for nhl patients at 3 months

Awards & highlights

Study Summary

This trial is testing a new cell therapy that consists of autologous (from the patient) genetically engineered T cells expressing a single-domain antibody that recognizes human CD19. CD19 is a protein found on the surface of B cells, a type of white blood cell. The T cells are fused to the CD3-epsilon subunit, which is incorporated into the endogenous T cell receptor (TCR) complex. This study is testing the safety of this new cell therapy in patients with aggressive non-Hodgkin lymphoma (NHL), high-risk indolent NHL, or adult acute lymphoblastic leukemia (ALL

Eligible Conditions

Non-Hodgkin's Lymphoma
Acute Lymphoblastic Leukemia
Large B-Cell Lymphoma
Mantle Cell Lymphoma
Follicular Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ orr rate and mrd negativity rate for all patients at 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~orr rate and mrd negativity rate for all patients at 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and orr rate and mrd negativity rate for all patients at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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 ALL as determined by overall response rate and Minimum Residual Disease (MRD) negativity rates

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)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment3 Interventions

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.

Group II: Phase 1Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

FDA approved

TC-110 T Cells

2020

Completed Phase 2

~10

Cyclophosphamide

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TCR2 TherapeuticsLead Sponsor

2 Previous Clinical Trials

42 Total Patients Enrolled

ClinicalStudy ChairTCR2 Therapeutics

1 Previous Clinical Trials

36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there past experiments that have utilized TC-110 T Cells?

"Initially developed in 1997 at the City of Hope Comprehensive Cancer Centre, TC-110 T Cells has undergone 1275 clinical trials to date. Currently, 889 investigations are still ongoing, with a significant number based out of Denver Colorado."

Answered by AI

What diseases or conditions is TC-110 T Cells regularly employed to address?

"TC-110 T Cells are generally employed to relieve the symptoms of multiple sclerosis, yet they may also be useful in combating a variety of ailments including mixed-cell type lymphoma, leukemia, myelocytic, acute and retinoblastoma."

Answered by AI

Is recruitment for this trial ongoing?

"Clinicaltrials.gov reveals that recruitment for this medical investigation, first posted on March 27th 2020, is still in progress. This data was last updated on June 25th 2020."

Answered by AI

How many participants can the research team include in this experiment?

"In order to proceed with this medical trial, 120 eligible candidates must be sourced. TCR2 Therapeutics will assume control of the project and manage it from locations such as Colorado Blood Cancer Institute in Denver and Sarah Cannon Research Institute based in Nashville."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04323657.