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

TICAROS Co., Ltd.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Refractory Large B-cell Lymphoma; High-grade B-cell Lymphoma (HGBL); Relapsed Large B-cell Lymphoma; Primary Mediastinal Large B-cell Lymphoma (PMBCL); Transformed Follicular Lymphoma (TFL); Diffuse Large B-cell Lymphoma (DLBCL)

Treatments: Drug: TC011

Study type: Interventional

Funder types: Industry

Identifiers

NCT07473167

Ticaros (Other Identifier)

TC011_DLBCL_01

Details and patient eligibility

About

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.

Enrollment: 98 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

TC011

Experimental group

Description:

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, TC011.

Treatment:

Drug: TC011