Phase 1/2 study of adoptive cell therapy using cultured tumor infiltrating lymphocytes with lympho-depleting non-myeloablative preconditioning for patients with advanced melanoma
- Conditions
- Advanced malignant melanoma
- Registration Number
- JPRN-UMIN000030143
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 14
Not provided
1) Have experienced non-myeloablative lymphocyte depleting preparative regimen or myeloablative lymphocyte depleting preparative regimen. 2) Have central nervous system infiltration that causes symptoms. 3) Subjects with intraocular melanoma. 4) Women who are pregnant or breastfeeding. 5) Subjects who take immunosuppressant drugs or adrenocortical steroid*. (*Excluding subjects who had adrenal insufficiency due to anti-PD1 or anti-CTLA4 antibodies therapy, which need steroid replacement dose) 6) Have active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system. 7) Have active other multiple primary malignancies. 8) Have active autoimmune disease. 9) Have a history of severe allergy to cyclophosphamide, fludarabine and IL-2. 10) Left ventricular ejection fraction (LVEF) <=50% 11) Forced expiratory volume in 1 second (FEV1.0%)<=60% 12) Has known history of HBV, HCV, HTLV-1, HIV. 13) Be determined to be ineligible by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method