Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma

Prior treatment

• Unresolved ≥Grade 2 toxicity from prior anticancer therapy (excluding hematologic abnormalities).
• Clinically significant cardiovascular disease within 6 months prior to screening.
• 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.

Other illness

• Active or prior malignancy within 2 years, except adequately treated non-melanoma skin cancer or carcinoma in situ.
• 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.
• Known hypersensitivity to components of TC011.

Other

• Histologic transformation to diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
• Active central nervous system involvement by lymphoma.
• Pregnant or breastfeeding women.

• 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.