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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
TC011 single-arm
Biological/VaccineCD19-targeted chimeric antigen receptor T-cell therapy
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: TC011 single-armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Proportion of patients achieving CR or PR per 2014 Lugano classification by independent review
Time frame
Up to 96 weeksSecondary outcomes
1
Complete Response Rate (CRR)
Proportion of subjects achieving complete response per 2014 Lugano classification by independent review
Time frame
Up to 96 weeks2
Disease Control Rate (DCR)
Proportion of subjects with complete response, partial response, or stable disease
Time frame
Up to 96 weeks3
Stable Disease Rate (SDR)
Proportion of subjects with stable disease per 2014 Lugano classification
Time frame
Up to 96 weeks4
Duration of Response (DOR)
Time from first documentation of response (CR or PR) to disease progression or death from any cause
Time frame
Up to 96 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: