Clinical trial · Interventional
Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients
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
NCT07473167CI-TRIAL-00105533TC011recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| High-grade B-cell Lymphoma (HGBL) | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Primary Mediastinal Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Refractory Large B-cell Lymphoma | — | UNRESOLVED | — |
| Relapsed Large B-cell Lymphoma | — | UNRESOLVED | — |
| Transformed Follicular Lymphoma (TFL) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TC011 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TC011
- description
- A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, TC011.
- interventionNames
- Drug: TC011
Primary outcomes (10)
- measure
- Phase1: Occurrence of Dose-Limiting Toxicities (DLTs)
- timeFrame
- Up to 4 weeks after TC011 infusion
- description
- A dose-limiting toxicity (DLT) is defined as any toxicity that is definitely related or probably related to the administration of TC011. The severity of toxicities will be assessed according to CTCAE Version 5.0, while cytokine-release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be evaluated based on the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading .
- measure
- Phase1: Determination of Maximum Tolerated Dose (MTD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.