Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients
Recruiting
Phase 1
Phase 2
Interventional Study
Relapsed 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)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 98 (estimated)
- Sponsor
- TICAROS Co., Ltd. · Industry
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Subjects must meet all criteria including:
* ≥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)
* Adequate…