TC011 (CD19 CAR-T) for relapsed or refractory large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Seoul National University Hospital
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Ah hyun Lim
• Email: ah.lim@ticaros.com
• Phone: 82+1029985238

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.