Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients (TC011)

March 10, 2026 updated by: TICAROS Co., Ltd.

A Multi-center, Single Arm, Open-label Phase 1/2 Clinical Trial to Evaluate Safety, and to Explore Efficacy of TC011(CD19 Targeted CAR-T) in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients

This is a multi-center, phase I/II study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Youngil Koh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects must meet all criteria including:

  • ≥19 years old, ECOG 0-2, life expectancy ≥12 weeks
  • Histologically confirmed B-cell lymphoma (WHO 2017)
  • Relapsed/refractory after ≥2 prior lines of systemic chemotherapy
  • ≥1 measurable lesion (longest diameter ≥1.5 cm)
  • Adequate organ, and pulmonary function
  • LVEF ≥40%
  • Able to undergo leukapheresis
  • For subjects of childbearing potential: agreement to use effective contraception for ≥6 months after TC011 infusion

Exclusion Criteria:

  • Unresolved ≥Grade 2 toxicities from prior therapy
  • Malignancy within 2 years except specified exceptions
  • Significant cardiac disease within 6 months
  • CNS involvement by lymphoma
  • Active HBV, HCV, HIV, syphilis
  • Rapidly progressing disease per investigator
  • Major surgery requiring general anesthesia within 4 weeks
  • Active or uncontrolled infection
  • Prior therapies such as anti-CD19 agents, adoptive T-cell therapy, gene therapy, allogeneic HSCT
  • Use of other investigational agents, immunosuppressants within protocol-specified windows
  • Pregnancy or breastfeeding
  • Hypersensitivity to study drug components
  • Leukapheresis-specific exclusions (recent chemotherapy, steroids, immunosuppressants)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TC011
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, TC011.
Drug: TC011
Anti-CD19 Chimeric Antigen Receptor T cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase1: Occurrence of Dose-Limiting Toxicities (DLTs)
Time Frame: Up to 4 weeks after TC011 infusion
A dose-limiting toxicity (DLT) is defined as any toxicity that is definitely related or probably related to the administration of TC011. The severity of toxicities will be assessed according to CTCAE Version 5.0, while cytokine-release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be evaluated based on the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading .
Up to 4 weeks after TC011 infusion
Phase1: Determination of Maximum Tolerated Dose (MTD)
Time Frame: up to 4weeks after TC011 infusion

DLT occurrence within the first 4 weeks after treatment initiation will be used to determine the maximum tolerated dose (MTD)

.
up to 4weeks after TC011 infusion
Phase1: Determination of Recommended Phase 2 Dose (RP2D)
Time Frame: Up to 12 weeks after TC011 infusion
The recommended Phase 2 dose (RP2D) will be determined based on evaluation of safety (including DLT incidence), tolerability, overall adverse event profile, and preliminary anti-tumor activity observed during the dose-escalation phase.
Up to 12 weeks after TC011 infusion
Phase 1: The number and incidence rate of treatment-emergent adverse events (TEAEs) as well as serious adverse events (SAEs) will be assessed
Time Frame: Up to 12 weeks after TC011 infusion
All adverse events (AEs) will be graded according to CTCAE version 5.0. Adverse events of special interest include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.
Up to 12 weeks after TC011 infusion
Phase1: Number of participants with abnormal physical examination findings
Time Frame: Baseline through Week 12
Clinically significant abnormalities identified during comprehensive physical examinations (general appearance, cardiovascular, respiratory, abdominal, neurologic, lymphatic systems) will be recorded.
Baseline through Week 12
Phase1: Number of participants with abnormal vital signs
Time Frame: Baseline through Week 12
Abnormal vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature) will be documented according to clinical significance.
Baseline through Week 12
Phase1: Number of participants with abnormal ECG readings
Time Frame: Baseline through Week 12
ECG findings will be categorized as Normal, Abnormal - Not Clinically Significant, or Abnormal - Clinically Significant.
Baseline through Week 12
Phase 1 : Number of participants with abnormal laboratory test results
Time Frame: Baseline through Week 12
Abnormal results from hematology, chemistry, liver function tests, renal function tests, coagulation, and other relevant laboratory parameters will be recorded.
Baseline through Week 12
Phase 1 : Presence of Replication-Competent Lentivirus (RCL) Through Week 12
Time Frame: Baseline through Week 12
Peripheral blood samples will be collected to evaluate the presence of replication-competent lentivirus (RCL). Samples will be analyzed by the central laboratory (BioComplete). If RCL is detected by quantitative PCR, additional confirmatory analyses and patient follow-up- including assessment of medical history for lentivirus-associated diseases such as malignancies, neurological disorders, or serologic conditions-will be conducted.
Baseline through Week 12
Phase 2 : Objective Response Rate (ORR)
Time Frame: up to 24 weeks after TC011 infusion
as the proportion of subjects achieving complete response (CR) or partial response (PR) as their best overall response (BOR) per the Lugano Criteria for Response Assessment (2014).
up to 24 weeks after TC011 infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Overall response rate (ORR)
Time Frame: 4weeks and 12weeks after TC011 infusion
To explore the efficacy of the TC011, evaluate tumor response 4weeks and 12weeks after TC011 administration according to 2014 Lugano classification
4weeks and 12weeks after TC011 infusion
Phase 2: Objective response rate (ORR)
Time Frame: Weeks 4, 12, 24, 48, 72, and 96
Weeks 4, 12, 24, 48, 72, and 96
Phase 2 Disease control rate (DCR)
Time Frame: at Weeks 4, 12, 24, 48, 72, and 96
at Weeks 4, 12, 24, 48, 72, and 96
Phase 2: Complete response rate (CRR)
Time Frame: at Weeks 4, 12, 24, 48, 72, and 96
at Weeks 4, 12, 24, 48, 72, and 96
Phase 2: Partial response rate (PRR)
Time Frame: at Weeks 4, 12, 24, 48, 72, and 96
at Weeks 4, 12, 24, 48, 72, and 96
Phase 2: Stable disease rate (SDR)
Time Frame: at Weeks 4, 12, 24, 48, 72, and 96
at Weeks 4, 12, 24, 48, 72, and 96
Phase 2: Progression-free survival (PFS)
Time Frame: at Weeks 4, 12, 24, 48, 72, and 96
at Weeks 4, 12, 24, 48, 72, and 96
Phase 2: Overall survival (OS)
Time Frame: at Weeks 4, 12, 24, 48, 72, and 96
at Weeks 4, 12, 24, 48, 72, and 96
Phase 2: Time to response (TTR)
Time Frame: at Weeks 4, 12, 24, 48, 72, and 96
at Weeks 4, 12, 24, 48, 72, and 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TICAROS Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2023

Primary Completion (Estimated)

February 11, 2028

Study Completion (Estimated)

March 10, 2028

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC011_DLBCL_01
  • Ticaros (Other Identifier: Ticaros)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Clinical Trials on TC011

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe