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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    73
  • sponsor
    Shenzhen BinDeBio Ltd.
Updated on 13 February 2022
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 IdentifierNCT03638206
SponsorShenzhen BinDeBio Ltd.
Last Modified on13 February 2022

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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