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

Summary

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

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 organ, and pulmonary function
* LVEF ≥40%
* Able to undergo leukapheresis
* For subjects of childbearing potential: agreement to use effective contraception for ≥6 months after TC011 infusion

Exclusion Criteria:

* Unresolved ≥Grade 2 toxicities from prior therapy
* Malignancy within 2 years except specified exceptions
* Significant cardiac disease within 6 months
* CNS involvement by lymphoma
* Active HBV, HCV, HIV, syphilis
* Rapidly progressing disease per investigator
* Major surgery requiring general anesthesia within 4 weeks
* Active or uncontrolled infection
* Prior therapies such as anti-CD19 agents, adoptive T-cell therapy, gene therapy, allogeneic HSCT
* Use of other investigational agents, immunosuppressants within protocol-specified windows
* Pregnancy or breastfeeding
* Hypersensitivity to study drug components
* Leukapheresis-specific exclusions (recent chemotherapy, steroids, immunosuppressants)

Conditions7

Interventions1

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