Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT03166397

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

Led by Sheba Medical Center · Updated on 2023-01-26

30

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with lymphodepletion and high-dose interleukin 2 (IL-2) has demonstrated reproducible objective response rates of approximately 50 percent in patients with highly advanced, refractory metastatic melanoma. Recent developments in theTIL ACT procedure facilitate the use of a reduced-intensity, non-myeloablative, lympho-depleting preparative regimen which is expected to be both less toxic and equally efficient compared to previous regimens. Recently patients recruited post Anti PD-1 therapy had inferior responses in comparison to the pre immune checkpoint inhibitors era. Therefore 2 new arms were added: 1. TIL-ACT with combination of 2 doses of Nivolumab fixed dose 480mg, pre and post TIL. 2. TIL-ACT with FMT given using colonoscopy once and 2 maintenance doses of 12 orally ingested capsules, concurrently with a single dose of Ipilimumab 1 mg/kg up to 100 mg.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Measurable metastatic melanoma with at least one lesion suitable for tumor-infiltrating lymphocyte (TIL) generation
  • Refractory to standard treatment
  • Patients with one or more brain metastases less than 1 cm each, or 1 or 2 brain metastases greater than 1 cm that have been treated and are stable for at least 6 weeks
  • Aged 18 years or older
  • Willing to use birth control from start of chemotherapy until 120 days after hospital release
  • Clinical performance status of ECOG 0 or 1
  • Absolute neutrophil count greater than 1000/mm3 without filgrastim support
  • Normal white blood cell count (greater than 3000/mm3)
  • Hemoglobin greater than 8.0 g/dL
  • Platelet count greater than 100,000/mm3
  • Seronegative for HIV antibody
  • Seronegative for Hepatitis B and Hepatitis C
  • Serum ALT/AST less than three times the upper limit of normal
  • Serum creatinine less than or equal to 1.6 mg/dL
  • Total bilirubin no more than 1.5 times the upper limit of normal (except in Gilbert Syndrome with total bilirubin less than 3 mg/dL)
  • Negative pregnancy test in women of childbearing potential
  • More than four weeks since any prior systemic therapy with toxicities recovered to grade 1 or less (except alopecia or vitiligo)
  • Minor surgical procedures allowed within past 3 weeks if toxicities are grade 1 or less
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women of childbearing potential
  • Need for systemic steroid therapy
  • Active systemic infections, coagulation disorders, or major illnesses of the heart, lungs, or immune system
  • Primary immunodeficiency diseases such as Severe Combined Immunodeficiency Disease or AIDS
  • Opportunistic infections
  • History of severe allergic reactions to any study agents, including penicillin or gentamicin
  • History of coronary revascularization or ischemic symptoms
  • Left ventricular ejection fraction (LVEF) less than or equal to 50%
  • Significant atrial or ventricular arrhythmias including atrial fibrillation, ventricular tachycardia, or second/third degree heart block
  • Pulmonary function tests (FEV1 and DLCO) less than or equal to 60% of predicted values

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sheba Medical Center

Ramat Gan, Israel, 5262100

Actively Recruiting

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Research Team

M

Meital Bar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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