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Recruiting NCT07473167

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

Phase I / Phase II Interventional Relapsed Large B-cell Lymphoma Refractory Large B-cell Lymphoma Diffuse Large B-cell Lymphoma (DLBCL) High-grade B-cell Lymphoma (HGBL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TC011.
Who it may be relevant to
Registry conditions: Relapsed Large B-cell Lymphoma, Refractory Large B-cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBL). Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug TC011
    Anti-CD19 Chimeric Antigen Receptor T cell

Primary outcome measures

  • Phase1: Occurrence of Dose-Limiting Toxicities (DLTs) [Time frame: Up to 4 weeks after TC011 infusion]
  • Phase1: Determination of Maximum Tolerated Dose (MTD) [Time frame: up to 4weeks after TC011 infusion]
  • Phase1: Determination of Recommended Phase 2 Dose (RP2D) [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 [Time frame: Up to 12 weeks after TC011 infusion]
  • Phase1: Number of participants with abnormal physical examination findings [Time frame: Baseline through Week 12]
  • Phase1: Number of participants with abnormal vital signs [Time frame: Baseline through Week 12]
  • Phase1: Number of participants with abnormal ECG readings [Time frame: Baseline through Week 12]
  • Phase 1 : Number of participants with abnormal laboratory test results [Time frame: Baseline through Week 12]
  • Phase 1 : Presence of Replication-Competent Lentivirus (RCL) Through Week 12 [Time frame: Baseline through Week 12]
  • Phase 2 : Objective Response Rate (ORR) [Time frame: up to 24 weeks after TC011 infusion]
Secondary outcome measures (9)
  • Phase 1: Overall response rate (ORR) [Time frame: 4weeks and 12weeks after TC011 infusion]
  • Phase 2: Objective response rate (ORR) [Time frame: Weeks 4, 12, 24, 48, 72, and 96]
  • Phase 2 Disease control rate (DCR) [Time frame: at Weeks 4, 12, 24, 48, 72, and 96]
  • Phase 2: Complete response rate (CRR) [Time frame: at Weeks 4, 12, 24, 48, 72, and 96]
  • Phase 2: Partial response rate (PRR) [Time frame: at Weeks 4, 12, 24, 48, 72, and 96]
  • Phase 2: Stable disease rate (SDR) [Time frame: at Weeks 4, 12, 24, 48, 72, and 96]
  • Phase 2: Progression-free survival (PFS) [Time frame: at Weeks 4, 12, 24, 48, 72, and 96]
  • Phase 2: Overall survival (OS) [Time frame: at Weeks 4, 12, 24, 48, 72, and 96]
  • Phase 2: Time to response (TTR) [Time frame: at Weeks 4, 12, 24, 48, 72, and 96]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT07473167 · TC011_DLBCL_01 · Ticaros

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗