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

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: Not yet recruiting
• Conditions: Follicular Lymphoma (FL)
• Intervention / Treatment: Biological: TC011 single-arm

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: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Proportion of patients achieving CR or PR per 2014 Lugano classification by independent review	Up to 96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate (CRR)	Proportion of subjects achieving complete response per 2014 Lugano classification by independent review	Up to 96 weeks
Disease Control Rate (DCR)	Proportion of subjects with complete response, partial response, or stable disease	Up to 96 weeks
Stable Disease Rate (SDR)	Proportion of subjects with stable disease per 2014 Lugano classification	Up to 96 weeks
Duration of Response (DOR)	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 from TC011 infusion to first documented response (CR or PR)	Up to 96 weeks
Progression-Free Survival (PFS)	Time from TC011 infusion to disease progression or death from any cause	Up to 96 weeks
Overall Survival (OS)	Time from TC011 infusion to death from any cause	Up to 96 weeks
Incidence and severity of adverse events	Incidence, severity, and type of adverse events graded per CTCAE v5.0	Up to 96 weeks

Collaborators and Investigators

• Sponsor: TICAROS Co., Ltd.
• Investigators: Principal Investigator: Won Seok Kim, MD, PhD, Samsung Medical Center, Department of Hematology-Oncology

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: CAR-T; Immunotherapy; Follicular Lymphoma; Adoptive Cell Therapy; CD19
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular
• Other Study ID 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