Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma
ConditionFollicular Lymphoma (FL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorTICAROS Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TC011 single-arm
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov