NCT07473167 Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients
| NCT ID | NCT07473167 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | TICAROS Co., Ltd. |
| Condition | Relapsed Large B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2023-08-03 |
| Primary Completion | 2028-02-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 98 participants in total. It began in 2023-08-03 with a primary completion date of 2028-02-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07473167 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Relapsed Large B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07473167 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07473167 currently recruiting?
Yes, NCT07473167 is actively recruiting participants. Contact the research team at ah.lim@ticaros.com for enrollment information.
Where is the NCT07473167 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07473167 clinical trial?
NCT07473167 is sponsored by TICAROS Co., Ltd.. The trial plans to enroll 98 participants.