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Tests treatment safety and results for Relapsed Large B-cell Lymphoma
Official title Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients
ClinicalTrials.gov ID: NCT07473167
What this study is testing
What is TC011?
TC011 is an investigational medicine, being studied as a potential treatment for relapsed large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- people 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)
You likely can't join if
- 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
See the full eligibility criteria
- people 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 people of childbearing potential: agreement to use effective contraception for ≥6 months after TC011 infusion
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.