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NCT Number: NCT07473167

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

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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Key information

Conditions

Relapsed Large B-cell Lymphoma Diffuse Large B-Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases High-grade B-cell Lymphoma (HGBL) Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Primary Mediastinal Large B-cell Lymphoma (PMBCL) Refractory Large B-cell Lymphoma Transformed Follicular Lymphoma (TFL)

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Youngil Koh

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TC011

Drug

Anti-CD19 Chimeric Antigen Receptor T cell

Primary outcomes

  1. Phase1: Occurrence of Dose-Limiting Toxicities (DLTs)

    Time frame: 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 .

  2. Phase1: Determination of Maximum Tolerated Dose (MTD)

    Time frame: 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)

    .

  3. Phase1: Determination of Recommended Phase 2 Dose (RP2D)

    Time frame: 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.

  4. Phase 1: The number and incidence rate of treatment-emergent adverse events (TEAEs) as well as serious adverse events (SAEs) will be assessed

    Time frame: 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.

  5. Phase1: Number of participants with abnormal physical examination findings

    Time frame: Baseline through Week 12

    Clinically significant abnormalities identified during comprehensive physical examinations (general appearance, cardiovascular, respiratory, abdominal, neurologic, lymphatic systems) will be recorded.

  6. Phase1: Number of participants with abnormal vital signs

    Time frame: 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.

  7. Phase1: Number of participants with abnormal ECG readings

    Time frame: Baseline through Week 12

    ECG findings will be categorized as Normal, Abnormal - Not Clinically Significant, or Abnormal - Clinically Significant.

  8. Phase 1 : Number of participants with abnormal laboratory test results

    Time frame: Baseline through Week 12

    Abnormal results from hematology, chemistry, liver function tests, renal function tests, coagulation, and other relevant laboratory parameters will be recorded.

  9. Phase 1 : Presence of Replication-Competent Lentivirus (RCL) Through Week 12

    Time frame: 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.

  10. Phase 2 : Objective Response Rate (ORR)

    Time frame: 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).

Secondary outcomes

  1. Phase 1: Overall response rate (ORR)

    Time frame: 4weeks and 12weeks after TC011 infusion

    To explore the efficacy of the TC011, evaluate tumor response 4weeks and 12weeks after TC011 administration according to 2014 Lugano classification

  2. Phase 2: Objective response rate (ORR)

    Time frame: Weeks 4, 12, 24, 48, 72, and 96

  3. Phase 2 Disease control rate (DCR)

    Time frame: at Weeks 4, 12, 24, 48, 72, and 96

  4. Phase 2: Complete response rate (CRR)

    Time frame: at Weeks 4, 12, 24, 48, 72, and 96

  5. Phase 2: Partial response rate (PRR)

    Time frame: at Weeks 4, 12, 24, 48, 72, and 96

  6. Phase 2: Stable disease rate (SDR)

    Time frame: at Weeks 4, 12, 24, 48, 72, and 96

  7. Phase 2: Progression-free survival (PFS)

    Time frame: at Weeks 4, 12, 24, 48, 72, and 96

  8. Phase 2: Overall survival (OS)

    Time frame: at Weeks 4, 12, 24, 48, 72, and 96

  9. Phase 2: Time to response (TTR)

    Time frame: at Weeks 4, 12, 24, 48, 72, and 96

Study contacts

Contact information is provided by the study sponsor or research team.

Ah hyun Lim

CONTACT

[email protected]

82+1029985238

admin

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

TICAROS Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: TC011

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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