Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma (TC011_FL_201)

January 14, 2026 updated by: TICAROS Co., Ltd.

A Multi-center, Single-arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of TC011 in Patients With Relapsed or Refractory Follicular Lymphoma

This Phase II, multi-center, single-arm, open-label study evaluates the efficacy and safety of TC011, a CD19-targeted CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a).

The primary endpoint is objective response rate (ORR) assessed by independent review using the Lugano 2014 classification.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-center, single-arm, open-label Phase II clinical trial designed to evaluate the efficacy and safety of TC011, a CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy, in adult patients with relapsed or refractory follicular lymphoma.

Eligible patients who meet all inclusion and exclusion criteria will undergo leukapheresis for the manufacture of TC011, followed by lymphodepleting chemotherapy and a single intravenous infusion of TC011. Patients will be followed according to the study schedule to assess efficacy and safety outcomes.

The primary efficacy endpoint is objective response rate assessed by independent review using standardized response criteria. Secondary endpoints include additional efficacy measures and safety evaluations. Exploratory assessments may include characterization of TC011-related cellular kinetics and biomarker analyses.

An independent Data Safety Monitoring Board will periodically review accumulated safety and efficacy data to ensure patient safety throughout the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ability to provide written informed consent.
  2. Age ≥19 years at the time of screening.
  3. Histologically confirmed follicular lymphoma Grade 1, 2, or 3a according to WHO 2017 classification.
  4. Relapsed or refractory disease after at least two prior systemic therapies including rituximab.
  5. ECOG performance status ≤2.
  6. Life expectancy ≥12 weeks.
  7. At least one measurable lesion (long diameter ≥1.5 cm).
  8. Adequate hepatic, renal, hematologic, pulmonary, and cardiac function.
  9. Eligible for leukapheresis and successful manufacture of TC011.
  10. Agreement to use effective contraception for at least 6 months after TC011 infusion.

Exclusion Criteria:

  1. Histologic transformation to diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
  2. Unresolved ≥Grade 2 toxicity from prior anticancer therapy (excluding hematologic abnormalities).
  3. Active or prior malignancy within 2 years, except adequately treated non-melanoma skin cancer or carcinoma in situ.
  4. Clinically significant cardiovascular disease within 6 months prior to screening.
  5. Active central nervous system involvement by lymphoma.
  6. Active uncontrolled infection, including HBV, HCV, HIV, or syphilis (protocol-defined exceptions apply).
  7. Active autoimmune or inflammatory neurologic disease.
  8. Rapidly progressive disease requiring urgent therapy.
  9. Prior treatment with anti-CD19 therapy, adoptive T-cell therapy, gene therapy, or allogeneic stem cell transplantation.
  10. Major surgery within 4 weeks prior to screening.
  11. Use of investigational agents within 4 weeks prior to screening.
  12. Known hypersensitivity to components of TC011.
  13. Pregnant or breastfeeding women.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TC011 single-arm
Single-arm, open-label study receiving TC011 infusion.
Biological: TC011 single-arm
CD19-targeted chimeric antigen receptor T-cell therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 96 weeks
Proportion of patients achieving CR or PR per 2014 Lugano classification by independent review
Up to 96 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Response Rate (CRR)
Time Frame: Up to 96 weeks
Proportion of subjects achieving complete response per 2014 Lugano classification by independent review
Up to 96 weeks
Disease Control Rate (DCR)
Time Frame: Up to 96 weeks
Proportion of subjects with complete response, partial response, or stable disease
Up to 96 weeks
Stable Disease Rate (SDR)
Time Frame: Up to 96 weeks
Proportion of subjects with stable disease per 2014 Lugano classification
Up to 96 weeks
Duration of Response (DOR)
Time Frame: Up to 96 weeks
Time from first documentation of response (CR or PR) to disease progression or death from any cause
Up to 96 weeks
Time to Response (TTR)
Time Frame: Up to 96 weeks
Time from TC011 infusion to first documented response (CR or PR)
Up to 96 weeks
Progression-Free Survival (PFS)
Time Frame: Up to 96 weeks
Time from TC011 infusion to disease progression or death from any cause
Up to 96 weeks
Overall Survival (OS)
Time Frame: Up to 96 weeks
Time from TC011 infusion to death from any cause
Up to 96 weeks
Incidence and severity of adverse events
Time Frame: Up to 96 weeks
Incidence, severity, and type of adverse events graded per CTCAE v5.0
Up to 96 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TICAROS Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Won Seok Kim, MD, PhD, Samsung Medical Center, Department of Hematology-Oncology

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TC011_FL_201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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