New combo tackles tough lymphoma
NCT ID NCT05322330
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new combination treatment for people with a type of blood cancer (B-cell non-Hodgkin's lymphoma) that did not respond to standard therapies. The treatment combined a drug (XPO-1 inhibitor) with specially engineered immune cells (CAR-T cells). The goal was to see if this combo could shrink tumors and control the disease. The study involved 20 adults and has been completed.
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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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20 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Feb 2024
- 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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18 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. Age ≥ 18 years. 2. Pathological immunohistochemistry or flow cytometry confirmed that R/ R B-cell Non-Hodgkin's Lymphoma with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1\> After 4 courses of standard first-line therapy or 2 courses of more than two-line therapy, the lesions were reduced by \<50%; 2\> R/ R B-cell Non-Hodgkin's Lymphoma with disease progression after first-line or induction therapy; 3\> After hematopoietic stem cell transplantation, new lesions appear or the size of previously affected lesions increased by more than 50%. 3. Previously treated with 2 or more lines of therapy. 4. ECOG≤2#. 5. The main organ functions need to meet the following conditions:LVEF≥50%;CR≤132 umol/l or CCr≥60 ml/min; ALT and AST≤2.5 times normal range#TB≤2 times ULN#Lung function≤Level 1; dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption\> 90%. 6. Pass the T-cell amplification test. 7. Voluntary tissue puncture/biopsy for tumor tissue retrieval before and after treatment. 8. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study. 9. Estimated survival time ≥3 months. 10. Voluntary signing of informed consent and good compliance. Exclusion Criteria: 1. 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. 2. The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control. 3. Active hepatitis B or active hepatitis C. 4. HIV infection. 5. Active acute or chronic graft-versus-host disease (GVHD) at the time of signing the informed consent form. 6. Participated in an investigational clinical trial of any other drug within 30 days prior to signing the informed consent form. 7. Received CAR-T cell therapy within 3 months prior to signing the informed consent form. 8. Received an allogeneic hematopoietic stem cell transplant within 6 months prior to signing the informed consent form. 9. Presence of contraindications to XPO-1 inhibitor. 10. 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. 11. Pregnant or breasting-feeding women. 12. 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.
- Promising CAR-T therapy trial for lymphoma withdrawn before it began
- Double-Barreled attack: stem cell transplant plus CAR-T shows promise for Hard-to-Treat lymphoma
- Experimental combo therapy for tough lymphoma shows promise but trial halted early
- New hope for tough lymphoma: experimental drug JS203 enters human testing