Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients

ConditionsRelapsed Large B-cell Lymphoma Refractory Large B-cell Lymphoma Diffuse Large B-cell Lymphoma (DLBCL)High-grade B-cell Lymphoma (HGBL)Transformed Follicular Lymphoma (TFL)Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age19+

SponsorTICAROS Co., Ltd.

About this trial

This is a multi-center, phase I/II study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.

Eligibility criteria

Qualifiers

≥19 years old, ECOG 0-2, life expectancy ≥12 weeks

Histologically confirmed B-cell lymphoma (WHO 2017)

Relapsed/refractory after ≥2 prior lines of systemic chemotherapy

≥1 measurable lesion (longest diameter ≥1.5 cm)

Disqualifiers

Unresolved ≥Grade 2 toxicities from prior therapy

Malignancy within 2 years except specified exceptions

Significant cardiac disease within 6 months

CNS involvement by lymphoma

Trial design

Treatments tested in this trial

TC011

Treatment groups

98 Participants

are divided into 1 treatment group

Sponsors and collaborators

TICAROS Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov