Adoptive Cell Therapy Following a Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 5, 2017

Primary Completion Date

January 1, 2025

Study Completion Date

June 1, 2026

Conditions
Malignant Melanoma Stage IV
Interventions
DRUG

Fludarabine

Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.

DRUG

Cyclophosphamide

Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.

BIOLOGICAL

TIL

TIL administration

DRUG

IL-2

Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient.

DRUG

Nivolumab

Nivolumab 480 mg fixed dose

DRUG

Ipilimumab

Ipilimumab 1 mg/kg up to 100 mg

DRUG

FMT Protocol

"FMT given both directly into the colon via colonoscopy and orally using capsules (12 capsules each time).~FMT will be taken from melanoma patients treated with Anti PD-1 who achieved a durable response of more than 12 months."

Trial Locations (1)

5262100

RECRUITING

Sheba Medical Center, Ramat Gan

All Listed Sponsors
lead

Sheba Medical Center

OTHER_GOV