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Relapsed Large B-cell LymphomaPhase 1/2TC011NCT07473167

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

A Phase 1/2 study testing TC011 in people with Relapsed Large B-cell Lymphoma and Refractory Large B-cell Lymphoma, run by TICAROS Co., Ltd. at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
TC011
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteSouth Korea
Study dates
3 Aug 2023to 10 Mar 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • LVEF ≥40%
  • Able to undergo leukapheresis
  • For subjects of childbearing potential: agreement to use effective contraception for ≥6 months after TC011 infusion

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ah hyun Lim contact

82+1029985238

ah.lim@ticaros.com

admin contact

admin@ticaros.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, Seoul, 03080

    Youngil Koh

    Recruiting

Other trials in South Korea

About this study

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

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.

Being tested
TC011
Keywords
TC011, CAR-T, Chimeric antigen receptor, CLIP
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TC011Drug

    Anti-CD19 Chimeric Antigen Receptor T cell

Study groups in NCT07473167
Study groupRoleWhat they receive
TC011ExperimentalA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, TC011.
Receives: Drug: TC011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 .

    Measured: Up to 4 weeks after TC011 infusion

  2. 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)

    .

    Measured: up to 4weeks after TC011 infusion

  3. 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.

    Measured: Up to 12 weeks after TC011 infusion

  4. 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.

    Measured: Up to 12 weeks after TC011 infusion

  5. 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.

    Measured: Baseline through Week 12

  6. 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.

    Measured: Baseline through Week 12

  7. Phase1: Number of participants with abnormal ECG readings

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

    Measured: Baseline through Week 12

  8. 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.

    Measured: Baseline through Week 12

  9. 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.

    Measured: Baseline through Week 12

  10. 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).

    Measured: up to 24 weeks after TC011 infusion

Secondary outcomes (9)

  1. Phase 1: Overall response rate (ORR)

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

    Measured: 4weeks and 12weeks after TC011 infusion

  2. Phase 2: Objective response rate (ORR)

    Measured: Weeks 4, 12, 24, 48, 72, and 96

  3. Phase 2 Disease control rate (DCR)

    Measured: at Weeks 4, 12, 24, 48, 72, and 96

  4. Phase 2: Complete response rate (CRR)

    Measured: at Weeks 4, 12, 24, 48, 72, and 96

  5. Phase 2: Partial response rate (PRR)

    Measured: at Weeks 4, 12, 24, 48, 72, and 96

  6. Phase 2: Stable disease rate (SDR)

    Measured: at Weeks 4, 12, 24, 48, 72, and 96

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

    Measured: at Weeks 4, 12, 24, 48, 72, and 96

  8. Phase 2: Overall survival (OS)

    Measured: at Weeks 4, 12, 24, 48, 72, and 96

  9. Phase 2: Time to response (TTR)

    Measured: at Weeks 4, 12, 24, 48, 72, and 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2026
  2. Study start3 Aug 2023
  3. Primary completion11 Feb 2028 (estimated)
  4. Study completion10 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07473167
Sponsor's protocol ID
TC011_DLBCL_01
Other IDs
Ticaros
Acronym
TC011
Status last verified
Mar 2026
First submitted
23 Dec 2025
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TC011 in people with Relapsed Large B-cell Lymphoma and Refractory Large B-cell Lymphoma, run by TICAROS Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ah hyun Lim (82+1029985238, ah.lim@ticaros.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase1: Occurrence of Dose-Limiting Toxicities (DLTs) (time frame: Up to 4 weeks after TC011 infusion). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07473167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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