Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies

Estado del programa

Reclutamiento

Fase

Fase 1/Fase 2

Inmunoterapia previa permitida

No

Ensayo dirigido por el CRC

Drogas

CAR-T cell immunotherapy

Etiquetas

MSI-H/ MMRd, MSS/ MMRp
Ubicación Situación
China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
Reclutamiento

Contactos

ZhongHua Yang
Póngase en contacto con
18938688105 zh.yang@bindebio.com

Criterios de inclusión

Criterios de inclusión:

If patients had receive immunotherapy, they should reach PR/NR, or recurrency.
Patients must be willing to sign an informed consent.
age: 4 to 70 years
Estimated survival of ≥ 12 weeks, but ≤ 2 years
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 .
Subjects with solid tumor must have measureable disease
Routine blood test:hemoglobin>=90 g/L; platelet>=50×10^9/L.
Renal function:BUN: 9-20mg / dl; serum creatinine=50 ml/min
Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded)
Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%.
ECOG score ≤2
Adequate venous access for apheresis, and no other contraindications for leukapheresis
Women of child-bearing age must have evidence of negative pregnancy test.
Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.

Criterios de exclusión

Criterios de exclusión:

ECOG >= 3
Patients with history of T cell tumors
Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
Acute or chronic GVHD after allogeneic hematopoiesis
steroid hormoneswere used before and after blood collection and infusion
HIV infection or active hepatitis B or hepatitis C infection
Uncontrolled active infection
Enrolled to other clinical study in the last 4 weeks.
Subjects with systemic auto-immune disease or immunodeficiency.
Subjects with CNS diseases.
Other patients that researchers considered unsuitable for inclusion

NCT ID

NCT03638206

Fecha en que se añadió el juicio

2018-08-20

Fecha de actualización

2019-12-11