Clinical Study of XPO-1 Inhibitors Plus CAR-T Cells in Relapsed Refractory B-cell Non-Hodgkin's Lymphoma
NCT ID: NCT05322330
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2022-02-10
2024-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XPO-1 Inhibitor+CAR-T Cells
XPO-1 Inhibitor plus CAR-T Cells
Selinexor
40-60mg QW,w-3～d-3,PO
Flu
25-30 mg/m2，d-5 ～d-3，qd，ivgtt
CTX
250-500 mg/m2，d-5 ～d-3，qd，ivgtt
CAR-T
2-5×10\^6 CAR-T/kg，ivgtt。
Interventions
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Selinexor
40-60mg QW,w-3～d-3,PO
Flu
25-30 mg/m2，d-5 ～d-3，qd，ivgtt
CTX
250-500 mg/m2，d-5 ～d-3，qd，ivgtt
CAR-T
2-5×10\^6 CAR-T/kg，ivgtt。
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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West China Hospital
OTHER
The General Hospital of Western Theater Command
OTHER
The Affiliated People's Hospital of Ningbo University Ningbo Yinzhou People's Hospital Community
UNKNOWN
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Yixing People's Hospital
OTHER
Affiliated Hospital of Jiangnan University
OTHER
Wuxi No. 2 People's Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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Depei Wu, M.D
Role: STUDY_CHAIR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R/R B-NHL 01
Identifier Type: -
Identifier Source: org_study_id
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