Status:
UNKNOWN
Clinical Study of XPO-1 Inhibitors Plus CAR-T Cells in Relapsed Refractory B-cell Non-Hodgkin's Lymphoma
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
West China Hospital
The General Hospital of Western Theater Command
Conditions:
Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Aim of this study will evaluate the Efficacy and Safety of XPO-1 inhibitors in combination with CAR-T cells in relapsed refractory B-cell non-Hodgkin's lymphoma
Detailed Description
B-cell non-Hodgkin's lymphoma (B-NHL) is the most common hematological malignancy originating from lymphohematopoietic tissue. Lymphoma is now one of the most rapidly growing malignancies worldwide, w...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- 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%.
- Previously treated with 2 or more lines of therapy.
- ECOG≤2#.
- 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%.
- Pass the T-cell amplification test.
- Voluntary tissue puncture/biopsy for tumor tissue retrieval before and after treatment.
- 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.
- Estimated survival time ≥3 months.
- Voluntary signing of informed consent and good compliance.
Exclusion
- 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.
- The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
- Active hepatitis B or active hepatitis C.
- HIV infection.
- Active acute or chronic graft-versus-host disease (GVHD) at the time of signing the informed consent form.
- Participated in an investigational clinical trial of any other drug within 30 days prior to signing the informed consent form.
- Received CAR-T cell therapy within 3 months prior to signing the informed consent form.
- Received an allogeneic hematopoietic stem cell transplant within 6 months prior to signing the informed consent form.
- Presence of contraindications to XPO-1 inhibitor.
- 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.
- Pregnant or breasting-feeding women.
- Conditions deemed by the researcher to be inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 10 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05322330
Start Date
February 10 2022
End Date
February 10 2024
Last Update
February 9 2023
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000