TC011 (CD19 CAR-T) for relapsed or refractory large B‑cell lymphoma
A Multi-center, Single Arm, Open-label Phase 1/2 Clinical Trial to Evaluate Safety, and to Explore Efficacy of TC011(CD19 Targeted CAR-T) in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients
This will test a CD19-targeted CAR-T therapy called TC011 in adults whose large B‑cell lymphoma has relapsed or not responded after prior treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | TICAROS Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, CAR-T |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT07473167 on ClinicalTrials.gov |
What this trial studies
This is a multicenter Phase 1/2 program testing the safety and activity of TC011, a CD19-targeted CAR-T product, in adults with relapsed or refractory large B‑cell lymphomas. Eligible patients have histologically confirmed disease and prior exposure to at least two lines of systemic therapy; they undergo leukapheresis for T‑cell collection and receive an infusion of the manufactured TC011 product. Phase 1 focuses on identifying a safe dose and characterizing toxicity, while Phase 2 expands at a selected dose to measure response rates and durability. Participants are closely monitored for treatment-related toxicities and tumor response over planned follow-up visits.
Who should consider this trial
Good fit: Ideal candidates are adults (≥19 years) with histologically confirmed relapsed or refractory large B‑cell lymphoma after at least two prior systemic therapies, ECOG 0–2, measurable disease, adequate organ function, and ability to undergo leukapheresis.
Not a fit: Patients with CNS involvement by lymphoma, active uncontrolled infections (HBV, HCV, HIV, syphilis), recent major cardiac events, prior anti‑CD19 or adoptive T‑cell/gene therapies, or inability to undergo leukapheresis are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If effective, TC011 could induce remissions in patients with relapsed or refractory large B‑cell lymphomas who have limited standard treatment options.
How similar studies have performed: Other CD19-targeted CAR‑T therapies have achieved high response rates and regulatory approvals in similar relapsed/refractory large B‑cell lymphoma populations, so the approach has proven promise, although TC011 itself remains investigational.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Seoul, Seoul
- Seoul National University Hospital — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Ah hyun Lim
- Email: ah.lim@ticaros.com
- Phone: 82+1029985238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.