OVACURE - Adoptive T cell therapy in recurrent ovarian cancer - OVACURE

Academisch Medisch Centrum0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•* Age * 18 years.
•* Histologically proven epithelial ovarian cancer.
•* Recurrent ovarian cancer
•* Presence of measurable progressive disease according to RECIST version 1.1 or
•elevated CA125, 2 times the upper normal limit (UNL) within 3 months and
•* Expected survival of at least 3 months.
•* WHO performance status 0-2.
•* Within the last 2 weeks prior to study day 0, vital laboratory parameters should be
•within normal range, except for the following laboratory parameters, which should
•be within the ranges specified :
•Lab Parameter Range
•Hemoglobin * 6,0 mmol/l
•Granulocytes * 1,500/µl
•Lymphocytes * 700/µl
•Platelets * 100,000/µl
•Creatinine clearance * 50 min/ml
•Serum bilirubin * 40 *mol/l
•ASAT and ALAT * 5 x the normal upper limit
•LDH * 2 x the normal upper limit
•* Viral tests:
•o Negative for HIV type 1/2, HTLV and TPHA
•o No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum
•o No antibodies against HCV (hepatitis C virus) in the serum
•* Able and willing to give valid written informed consent.
•* Prior treatment, including immunotherapy e.g. with anti-PD(L)1, is allowed but
•systemic therapy and radiotherapy must have been discontinued for at least two
•weeks before study entry.
•* Patients should have PD.

•Patients will be excluded from the study for any of the following reasons:
•* Patients with brain metastases
•* Clinically significant heart disease (NYHA Class III or IV).
•* Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
•* Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
•* Other malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer and in situ cervical carcinoma.
•* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
•* Lack of availability for follow-up assessments.
•* Pregnancy or breastfeeding.

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