Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma (NCT07360288) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma
40 participantsStarted 2026-03-01
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Histologic transformation to diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.