The Safety and Efficacy of Double-target CART-19 and 20 Cells in Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT06160362
Last Updated: 2023-12-07
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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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-10-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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double-target CART-19 and 20
Patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of double-target CART-19 and 20 cells. The double-target CART-19 and 20 cells are to be administered on day0.
CART-19 and 20 cells
Double-target CART-19 and 20 cells will be administered on day0 after completion of the chemotherapy.
Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 500mg/m2/day IV for 2 days(Day-3 to day-2).
Fludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-4 to day-2).
Interventions
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CART-19 and 20 cells
Double-target CART-19 and 20 cells will be administered on day0 after completion of the chemotherapy.
Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 500mg/m2/day IV for 2 days(Day-3 to day-2).
Fludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-4 to day-2).
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed as R/R NHL
3. CD19/CD20 positive confirmed by cell flow cytometry or immunohistochemistry
4. Having at least one measurable lesions
5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
6. Life expectancy no less than 3 months
7. enough main organ function
8. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and 12 months after this study
9. Agreeing to sign the written informed consents
Exclusion Criteria
2. Active GVHD
3. History of severe pulmonary dysfunction
4. Active malignant tumor need be treated at the same time
5. Uncontrolled active acute/chronic infection
6. Severe autoimmune diseases or congenital immunodeficiency
7. Untreated active hepatitis
8. HIV-positive, AIDS patients and syphilis infection
9. History of severe allergies to biological products
10. Patients with a history of mental illness
11. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
12. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
18 Years
75 Years
ALL
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Zhihua Yao, PhD
Director
Principal Investigators
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Zhihua Yao, M.D. Ph.D
Role: STUDY_DIRECTOR
Henan Cancer Hospital
Locations
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Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Zhihua Yao, M.D. Ph.D
Role: primary
Yanyan Liu, M.D. Ph.D
Role: backup
Other Identifiers
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Th_C155
Identifier Type: -
Identifier Source: org_study_id