A Pilot Study to Evaluate Safety and Efficacy of HLA-mismatched Granulocyte Transfusions in the Treatment of Patients with Solid Malignant Tumors Who Are Resistant to Standard Cancer Therapy or for Whom No Standard Cancer Therapy Exists - Nil

Munogenics Inc USA0 个研究点目标入组 22 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Ability to understand and willingness to sign a written informed consent document.
•2. All patients must have histologically or cytologically confirmed solid malignant tumors for which standard curative do not exist or are no longer effective.
•3. Subjects with measurable disease i.e. lesions that can be accurately measured in at least one dimension (longest diameter recorded) as more than 20 mm with conventional technique or as more than 10 mm with spiral CT scan.
•4. More than 4 weeks should have elapsed since prior cytotoxic therapy, radiation therapy, and major surgery and have recovered completely from adverse effects of any prior medical therapy, radiation therapy, and surgery
•5. ECOG Performance status of more than or equal to 2.
•6. Subjects must have adequate organ function, such as Hb>= 8g/dl, absolute neutrophils >=1,000/Âµl, platelet transfusion independent, platelet count >=100,000/Âµl, serum bilirubin <=2 mg/dl, AST/ALT less than 3xULN and serum creatinine <=2 mg/dl.
•7. Life expectancy of at least 4 months.
•8. Non-pregnant and non-nursing.
•9. Women and men of reproductive potential should agree to use an effective means of birth control.
•10. Women at the reproductive age should have a negative serum or urine pregnancy test before treatment.
•11. Negative panel reactive antibody test (absence of serum HLA Class I and II antibodies).

•1)Uncontrolled diabetes mellitus, significant cardiac disease e.g. recent myocardial infarction (within 30 days) or active serious infection.
•2)Subjects with evidence of brain tumors or brain metastases at the time of screening.
•3)Subjects who have received any other investigational drug within 30 days prior to day-1 of granulocyte infusion.
•4)Known HIV infection.
•5)Recent use (within 30 days) of immunosuppressive agents other than steroids.
•6)Prior history of stem cell transplantation.
•7)Prior history of fludarabine therapy.
•8)Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk or deems the subject not suitable for participation in the study.

发起方

Munogenics Inc USA