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

STATUS

Recruiting
days left to enroll

25
participants needed

73
sponsor

Shenzhen BinDeBio Ltd.

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Updated on 13 February 2022

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renal function

cancer

fludarabine

hematologic malignancy

cyclophosphamide

hla-a

flow cytometry

ejection fraction

blood test

leukapheresis

c-MET

apheresis

solid tumor

ny-eso-1

hematological malignancy

renal function tests

blood urea nitrogen

kidney function test

bcma

Summary

This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.

Description

The study is a multi-target gene-modified immunotherapy. CAR-T/TCR-T cells include ten different tumor-specific antibody.They are as following:anti-CD19 antibody for B cell leukemia and lymphoma;anti-CD22 antibody for B cell leukemia and lymphoma;anti-CD33 antibody for myeloid leukemia;anti-BCMA antibody for multiple myeloma;anti-CD38 antibody for multiple myeloma;anti-NY-ESO-1 antibody for multiple myeloma,esophagus cancer,lung cancer,melanoma and synovial sarcoma;anti-DR5 antibody for hepatoma;anti-C-met antibody for hepatoma,colorectal cancer,ovarian cancer and renal carcinoma;anti-EGFR V III antibody for hepatoma,lung cancer and glioma;anti-Mesothelin antibody for gastric cancer,pancreatic cancer and mesothelioma.

Details

Condition	B-cell Acute Lymphoblastic Leukemia, Lymphoma, Myeloid Leukemia, Multiple Myeloma, Hepatoma, Gastric Cancer, Pancreatic Cancer, Mesothelioma, Colorectal Cancer, Esophagus Cancer, Lung Cancer, Glioma, Melanoma, Synovial Sarcoma, Ovarian Cancer, Renal Carcinoma
Treatment	CAR-T cell immunotherapy
Clinical Study Identifier	NCT03638206
Sponsor	Shenzhen BinDeBio Ltd.
Last Modified on	13 February 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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-A0201 is required at the same time
	Subjects with solid tumor must have measureable disease
	Routine blood testhemoglobin>=90 g/L; platelet>=5010^9/L
	Renal function:BUN: 9-20mg / dl; serum creatinine<= 1.5 times upper limits of normal; endogenous creatinine clearance rate>=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
Exclusion Criteria
	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

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