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

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 .

Time frame: 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) .

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: up to 24 weeks after TC011 infusion