Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07473167
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07473167
Study Brief:
Protocol Section:
NCT07473167