Study of Safety and Efficacy of TC011 in the Relapsed/Refractory Large B Cell Non-Hodgkin Lymphoma Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

TC011: Anti-CD19 Chimeric Antigen Receptor T cell

Study summary

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.

Eligibility

Primary outcome measure(s)

• Phase1: Occurrence of Dose-Limiting Toxicities (DLTs) — Up to 4 weeks after TC011 infusion
  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 .
• Phase1: Determination of Maximum Tolerated Dose (MTD) — up to 4weeks after TC011 infusion
  DLT occurrence within the first 4 weeks after treatment initiation will be used to determine the maximum tolerated dose (MTD) .
• Phase1: Determination of Recommended Phase 2 Dose (RP2D) — Up to 12 weeks after TC011 infusion
  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.
• Phase 1: The number and incidence rate of treatment-emergent adverse events (TEAEs) as well as serious adverse events (SAEs) will be assessed — Up to 12 weeks after TC011 infusion
  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.
• Phase1: Number of participants with abnormal physical examination findings — Baseline through Week 12
  Clinically significant abnormalities identified during comprehensive physical examinations (general appearance, cardiovascular, respiratory, abdominal, neurologic, lymphatic systems) will be recorded.
• Phase1: Number of participants with abnormal vital signs — Baseline through Week 12
  Abnormal vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature) will be documented according to clinical significance.
• Phase1: Number of participants with abnormal ECG readings — Baseline through Week 12
  ECG findings will be categorized as Normal, Abnormal - Not Clinically Significant, or Abnormal - Clinically Significant.
• Phase 1 : Number of participants with abnormal laboratory test results — Baseline through Week 12
  Abnormal results from hematology, chemistry, liver function tests, renal function tests, coagulation, and other relevant laboratory parameters will be recorded.
• Phase 1 : Presence of Replication-Competent Lentivirus (RCL) Through Week 12 — Baseline 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.
• Phase 2 : Objective Response Rate (ORR) — up to 24 weeks after TC011 infusion
  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).

Trial sites (1)

Other trials for the same condition