Promising CAR-T therapy trial for lymphoma withdrawn before it began
NCT ID NCT05312476
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aimed to test a new CAR-T cell therapy that targets a protein called Igβ on cancer cells in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. The trial planned to enroll patients who had already tried at least two other treatments. However, the study was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR-T cells targeting Igβ
- What this could lead to
- If successful, this approach could offer a new treatment option for patients with hard-to-treat B-cell non-Hodgkin's lymphoma.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no data exists. CAR-T therapies carry risks like severe immune reactions and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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6 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. Voluntary signing of informed consent and good compliance. 2. Age ≥ 6 years. 3. Previously treated with 2 or more lines of therapy. 4. Has a measurable target lesion. 5. ECOG 0-1#. 6. Have appropriate organ function, subject to the following criteria (except for abnormal liver function due to tumor infiltration): AST≤3 times upper limit of normal#ALT≤3 times upper limit of normal# TB≤2 times ULN, unless combined with Gilbert's syndrome #Patients with Gilbert's syndrome with TB≤ 3 times ULN and DB≤ 1.5 times ULN can be include # Scr ≤1.5 times ULN or CCr≥60 ml/min# Lung function≤Level 1; dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption\> 91%# INR≤1.5 times ULN# aPTT≤1.5 times ULN. 7. negative blood/urine pregnancy test in women of childbearing age within 7 days prior to cell infusion, and any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least six months after the study treatment is administered. 8. Pass the T-cell amplification test. 9. Have adequate venous access to single or venous blood and no other contraindications to leukocyte isolation. 10. Estimated survival time ≥3 months. Exclusion Criteria: 1. Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma), except for cured malignant tumors with no active lesions for 3 years; Adequate treatment of inactive lesions in non-melanoma skin cancer, malignant tonsilloma or carcinoma in situ. 2. Have used immunosuppressants or hormones within 2 weeks prior to signing informed consent, or plan to have to use immunosuppressants or high-dose hormones (e.g. prednisone \>15mg) after signing informed consent, specifically systemic treatment, excluding treatment with topical or inhaled corticosteroids. 3. The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control. 4. HIV, Syphilis or COVID-19 infection. 5. Active hepatitis B or active hepatitis C. 6. Previous or current CNS disease other than this disease, such as seizures, cerebrovascular ischaemia/hemorrhage, dementia, cerebellar disease or any CNS-related autoimmune disease. 7. A history of cardiac angioplasty or stent placement within 12 months prior to signing the informed consent form, or a history of myocardial infarction, unstable angina or other clinically significant heart disease. 8. Patients with primary immunodeficiency. 9. Have had a severe tachyphylaxis to any of the drugs to be used in this study. 10. Live vaccination within 6 weeks prior to screening. 11. Pregnant or breasting-feeding women. 12. Active autoimmune diseases. 13. Active acute or chronic graft-versus-host disease (GVHD) at the time of signing the informed consent form. 14. Received an allogeneic hematopoietic stem cell transplant within 6 months prior to signing the informed consent form. 15. Participated in an investigational clinical trial of any other drug within 30 days prior to signing the informed consent form. 16. Conditions deemed by the researcher to be inappropriate for participation in this clinical trial.
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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.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.