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

NCT07473167 | Recruiting Phase 1 DMC

• 2 other identifiers: TC011_DLBCL_01Ticaros
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed Large B-cell Lymphoma; Refractory Large B-cell Lymphoma; Diffuse Large B-cell Lymphoma (DLBCL); High-grade B-cell Lymphoma (HGBL); Transformed Follicular Lymphoma (TFL); Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Keywords

TC011; CAR-T; Chimeric antigen receptor; CLIP

Outcome Measures

Primary Outcomes (10)

• 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.

  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

Secondary Outcomes (9)

• Phase 1: Overall response rate (ORR)

  4weeks and 12weeks after TC011 infusion

• Phase 2: Objective response rate (ORR)

  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

Study Arms (1)

TC011

EXPERIMENTAL

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, TC011.

Drug: TC011

Interventions

TC011 DRUG

Anti-CD19 Chimeric Antigen Receptor T cell

TC011

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• TICAROS Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Ah hyun Lim

CONTACT

82+1029985238; ah.lim@ticaros.com

admin

CONTACT

admin@ticaros.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: March 16, 2026
• Study Start: August 3, 2023
• Primary Completion (Estimated): February 11, 2028
• Study Completion (Estimated): March 10, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

KR (1)