New CAR-T therapy aims to control Hard-to-Treat lymphoma
NCT ID NCT07360288
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment called TC011 for adults with follicular lymphoma that has come back or not responded to at least two prior therapies. TC011 is a type of CAR-T cell therapy that targets cancer cells. The main goal is to see how many patients' tumors shrink or disappear after treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ability to provide written informed consent. 2. Age ≥19 years at the time of screening. 3. Histologically confirmed follicular lymphoma Grade 1, 2, or 3a according to WHO 2017 classification. 4. Relapsed or refractory disease after at least two prior systemic therapies including rituximab. 5. ECOG performance status ≤2. 6. Life expectancy ≥12 weeks. 7. At least one measurable lesion (long diameter ≥1.5 cm). 8. Adequate hepatic, renal, hematologic, pulmonary, and cardiac function. 9. Eligible for leukapheresis and successful manufacture of TC011. 10. Agreement to use effective contraception for at least 6 months after TC011 infusion. Exclusion Criteria: 1. Histologic transformation to diffuse large B-cell lymphoma or follicular lymphoma Grade 3b. 2. Unresolved ≥Grade 2 toxicity from prior anticancer therapy (excluding hematologic abnormalities). 3. Active or prior malignancy within 2 years, except adequately treated non-melanoma skin cancer or carcinoma in situ. 4. Clinically significant cardiovascular disease within 6 months prior to screening. 5. Active central nervous system involvement by lymphoma. 6. Active uncontrolled infection, including HBV, HCV, HIV, or syphilis (protocol-defined exceptions apply). 7. Active autoimmune or inflammatory neurologic disease. 8. Rapidly progressive disease requiring urgent therapy. 9. Prior treatment with anti-CD19 therapy, adoptive T-cell therapy, gene therapy, or allogeneic stem cell transplantation. 10. Major surgery within 4 weeks prior to screening. 11. Use of investigational agents within 4 weeks prior to screening. 12. Known hypersensitivity to components of TC011. 13. Pregnant or breastfeeding women.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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