Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma

Starting soon · Phase 2

Conditions studied: Follicular Lymphoma (FL)

In brief

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.

Key facts

Study ID

NCT07360288

Run by

TICAROS Co., Ltd.

People needed

40

Starts

2026-03-01

Expected to finish

2030-02-28

Last updated by the study team

2026-01-22

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Full record on ClinicalTrials.gov

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