Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies
NCT ID: NCT03638206
Last Updated: 2019-12-11
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
PHASE1/PHASE2
73 participants
INTERVENTIONAL
2018-03-01
2023-03-01
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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CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.
CAR-T cell immunotherapy
According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.
Interventions
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CAR-T cell immunotherapy
According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.
Eligibility Criteria
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Inclusion Criteria
2. Patients must be willing to sign an informed consent.
3. age: 4 to 70 years
4. Estimated survival of ≥ 12 weeks, but ≤ 2 years
5. Blood tumor or solid tumor was diagnosed by histopathology.Positive expression of CD19, CD22, CD33, CD38, BCMA, NY-ESO-1, c-met, Mesothelin, CEGFRvIII and DR5 was confirmed by biopsy IHC test or flow cytometry test. If NY-ESO-1 is positive expression ,positive HLA-A\*0201 is required at the same time .
6. Subjects with solid tumor must have measureable disease
7. Routine blood test：hemoglobin\>=90 g/L; platelet\>=50×10\^9/L.
8. Renal function:BUN: 9-20mg / dl; serum creatinine\<= 1.5 times upper limits of normal; endogenous creatinine clearance rate\>=50 ml/min
9. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded)
10. Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)\>=55%.
11. ECOG score ≤2
12. Adequate venous access for apheresis, and no other contraindications for leukapheresis
13. Women of child-bearing age must have evidence of negative pregnancy test.
14. Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.
Exclusion Criteria
2. Patients with history of T cell tumors
3. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
4. Acute or chronic GVHD after allogeneic hematopoiesis
5. steroid hormoneswere used before and after blood collection and infusion
6. HIV infection or active hepatitis B or hepatitis C infection
7. Uncontrolled active infection
8. Enrolled to other clinical study in the last 4 weeks.
9. Subjects with systemic auto-immune disease or immunodeficiency.
10. Subjects with CNS diseases.
11. Other patients that researchers considered unsuitable for inclusion
4 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
Shenzhen BinDeBio Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Yi Zhang, MD, PhD
Role: primary
Other Identifiers
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2018ZDYFY-BinDeDBD
Identifier Type: -
Identifier Source: org_study_id