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| ID | Type | Description | Link |
|---|---|---|---|
| Ticaros | Other Identifier | Ticaros |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TC011 | Experimental | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, TC011. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC011 | Drug | Anti-CD19 Chimeric Antigen Receptor T cell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase1: Occurrence of Dose-Limiting Toxicities (DLTs) | 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 . | Up to 4 weeks after TC011 infusion |
| Phase1: Determination of Maximum Tolerated Dose (MTD) | DLT occurrence within the first 4 weeks after treatment initiation will be used to determine the maximum tolerated dose (MTD) . | up to 4weeks after TC011 infusion |
| Phase1: Determination of Recommended Phase 2 Dose (RP2D) | The recommended Phase 2 dose (RP2D) will be determined based on evaluation of safety (including DLT incidence), tolerability, overall adverse event profile, and preliminary anti-tumor activity observed during the dose-escalation phase. | Up to 12 weeks after TC011 infusion |
| Phase 1: The number and incidence rate of treatment-emergent adverse events (TEAEs) as well as serious adverse events (SAEs) will be assessed | All adverse events (AEs) will be graded according to CTCAE version 5.0. Adverse events of special interest include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria. | Up to 12 weeks after TC011 infusion |
| Phase1: Number of participants with abnormal physical examination findings | Clinically significant abnormalities identified during comprehensive physical examinations (general appearance, cardiovascular, respiratory, abdominal, neurologic, lymphatic systems) will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Overall response rate (ORR) | To explore the efficacy of the TC011, evaluate tumor response 4weeks and 12weeks after TC011 administration according to 2014 Lugano classification | 4weeks and 12weeks after TC011 infusion |
| Phase 2: Objective response rate (ORR) |
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Inclusion Criteria:
Subjects must meet all criteria including:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ah hyun Lim | Contact | 82+1029985238 | ah.lim@ticaros.com | |
| admin | Contact | admin@ticaros.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Seoul | 03080 | South Korea |
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| Baseline through Week 12 |
| Phase1: Number of participants with abnormal vital signs | Abnormal vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature) will be documented according to clinical significance. | Baseline through Week 12 |
| Phase1: Number of participants with abnormal ECG readings | ECG findings will be categorized as Normal, Abnormal - Not Clinically Significant, or Abnormal - Clinically Significant. | Baseline through Week 12 |
| Phase 1 : Number of participants with abnormal laboratory test results | Abnormal results from hematology, chemistry, liver function tests, renal function tests, coagulation, and other relevant laboratory parameters will be recorded. | Baseline through Week 12 |
| Phase 1 : Presence of Replication-Competent Lentivirus (RCL) Through Week 12 | Peripheral blood samples will be collected to evaluate the presence of replication-competent lentivirus (RCL). Samples will be analyzed by the central laboratory (BioComplete). If RCL is detected by quantitative PCR, additional confirmatory analyses and patient follow-up- including assessment of medical history for lentivirus-associated diseases such as malignancies, neurological disorders, or serologic conditions-will be conducted. | Baseline through Week 12 |
| Phase 2 : Objective Response Rate (ORR) | as the proportion of subjects achieving complete response (CR) or partial response (PR) as their best overall response (BOR) per the Lugano Criteria for Response Assessment (2014). | up to 24 weeks after TC011 infusion |
| Weeks 4, 12, 24, 48, 72, and 96 |
| Phase 2 Disease control rate (DCR) | at Weeks 4, 12, 24, 48, 72, and 96 |
| Phase 2: Complete response rate (CRR) | at Weeks 4, 12, 24, 48, 72, and 96 |
| Phase 2: Partial response rate (PRR) | at Weeks 4, 12, 24, 48, 72, and 96 |
| Phase 2: Stable disease rate (SDR) | at Weeks 4, 12, 24, 48, 72, and 96 |
| Phase 2: Progression-free survival (PFS) | at Weeks 4, 12, 24, 48, 72, and 96 |
| Phase 2: Overall survival (OS) | at Weeks 4, 12, 24, 48, 72, and 96 |
| Phase 2: Time to response (TTR) | at Weeks 4, 12, 24, 48, 72, and 96 |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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