OVACURE - Adoptive T cell therapy in recurrent ovarian cancer

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

* 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
confirmed.
* 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.

Exclusion Criteria

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.