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

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.

Primary Outcome Measures

  • Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 [ Time Frame: 60 months ]
    Safety evaluation

Secondary Outcome Measures

  • Clinical response [ Time Frame: 60 months ]
    Clinical response to T-cell infusion, especially change of tumor volume will be evaluated by comparing disease identified by computed tomography, magnetic resonance imaging.

  • CAR-T cells testing [ Time Frame: 60 months ]
    The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or flow cytometry to evaluate the proliferation in vivo and long-term survival.
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-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<= 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 hormones were 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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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: August 31st, 2018.

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Last update: January 19, 2018. 04:57:31 pm.