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Follicular Lymphoma (FL)Phase 2TC011_FL_201NCT07360288

Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma

A Phase 2 study testing TC011 single-arm in people with Follicular Lymphoma (FL), run by TICAROS Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This Phase II, multi-center, single-arm, open-label study evaluates the efficacy and safety of TC011, a CD19-targeted CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Follicular Lymphoma (FL)
What is being tested?
TC011 single-arm
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Mar 2026to 28 Feb 2030
Phase
Phase 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

  • Ability to provide written informed consent.
  • Age ≥19 years at the time of screening.
  • Histologically confirmed follicular lymphoma Grade 1, 2, or 3a according to WHO 2017 classification.
  • Relapsed or refractory disease after at least two prior systemic therapies including rituximab.
  • ECOG performance status ≤2.
  • Life expectancy ≥12 weeks.
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  • At least one measurable lesion (long diameter ≥1.5 cm).
  • Adequate hepatic, renal, hematologic, pulmonary, and cardiac function.
  • Eligible for leukapheresis and successful manufacture of TC011.
  • Agreement to use effective contraception for at least 6 months after TC011 infusion.

Who cannot join

  • Histologic transformation to diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
  • Unresolved ≥Grade 2 toxicity from prior anticancer therapy (excluding hematologic abnormalities).
  • Active or prior malignancy within 2 years, except adequately treated non-melanoma skin cancer or carcinoma in situ.
  • Clinically significant cardiovascular disease within 6 months prior to screening.
  • Active central nervous system involvement by lymphoma.
  • Active uncontrolled infection, including HBV, HCV, HIV, or syphilis (protocol-defined exceptions apply).
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  • Active autoimmune or inflammatory neurologic disease.
  • Rapidly progressive disease requiring urgent therapy.
  • Prior treatment with anti-CD19 therapy, adoptive T-cell therapy, gene therapy, or allogeneic stem cell transplantation.
  • Major surgery within 4 weeks prior to screening.
  • Use of investigational agents within 4 weeks prior to screening.
  • Known hypersensitivity to components of TC011.
  • Pregnant or breastfeeding women.

About this study

Official title: A Multi-center, Single-arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of TC011 in Patients With Relapsed or Refractory Follicular Lymphoma

This Phase II, multi-center, single-arm, open-label study evaluates the efficacy and safety of TC011, a CD19-targeted CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a).

The primary endpoint is objective response rate (ORR) assessed by independent review using the Lugano 2014 classification.

Read the detailed description

This is a multi-center, single-arm, open-label Phase II clinical trial designed to evaluate the efficacy and safety of TC011, a CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy, in adult patients with relapsed or refractory follicular lymphoma.

Eligible patients who meet all inclusion and exclusion criteria will undergo leukapheresis for the manufacture of TC011, followed by lymphodepleting chemotherapy and a single intravenous infusion of TC011. Patients will be followed according to the study schedule to assess efficacy and safety outcomes.

The primary efficacy endpoint is objective response rate assessed by independent review using standardized response criteria. Secondary endpoints include additional efficacy measures and safety evaluations. Exploratory assessments may include characterization of TC011-related cellular kinetics and biomarker analyses.

An independent Data Safety Monitoring Board will periodically review accumulated safety and efficacy data to ensure patient safety throughout the study.

Being tested
TC011 single-arm
Keywords
Follicular Lymphoma, CAR-T, CD19, Adoptive Cell Therapy, Immunotherapy
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • TC011 single-armBiological

    CD19-targeted chimeric antigen receptor T-cell therapy

Study groups in NCT07360288
Study groupRoleWhat they receive
TC011 single-armExperimentalSingle-arm, open-label study receiving TC011 infusion.
Receives: Biological: TC011 single-arm

What is being measured

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

  1. Objective Response Rate (ORR)

    Proportion of patients achieving CR or PR per 2014 Lugano classification by independent review

    Measured: Up to 96 weeks

Secondary outcomes (8)

  1. Complete Response Rate (CRR)

    Proportion of subjects achieving complete response per 2014 Lugano classification by independent review

    Measured: Up to 96 weeks

  2. Disease Control Rate (DCR)

    Proportion of subjects with complete response, partial response, or stable disease

    Measured: Up to 96 weeks

  3. Stable Disease Rate (SDR)

    Proportion of subjects with stable disease per 2014 Lugano classification

    Measured: Up to 96 weeks

  4. Duration of Response (DOR)

    Time from first documentation of response (CR or PR) to disease progression or death from any cause

    Measured: Up to 96 weeks

  5. Time to Response (TTR)

    Time from TC011 infusion to first documented response (CR or PR)

    Measured: Up to 96 weeks

  6. Progression-Free Survival (PFS)

    Time from TC011 infusion to disease progression or death from any cause

    Measured: Up to 96 weeks

  7. Overall Survival (OS)

    Time from TC011 infusion to death from any cause

    Measured: Up to 96 weeks

  8. Incidence and severity of adverse events

    Incidence, severity, and type of adverse events graded per CTCAE v5.0

    Measured: Up to 96 weeks

Timeline

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

  1. First posted22 Jan 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 May 2028 (estimated)
  4. Study completion28 Feb 2030 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07360288
Sponsor's protocol ID
TC011_FL_201
Acronym
TC011_FL_201
Status last verified
Jan 2026
First submitted
14 Jan 2026
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TC011 single-arm in people with Follicular Lymphoma (FL), run by TICAROS Co., Ltd..

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 10 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: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 96 weeks). 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 NCT07360288.

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 22 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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