Actively Recruiting
T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma
Led by Inge Marie Svane · Updated on 2025-01-20
10
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess wether it is safe and feasible to treat patients with tumor infiltrating lymphocytes that have been silenced for PD-1, using CRISPR-Cas9.
CONDITIONS
Official Title
T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV).
- Progressive disease after standard treatment with anti-PD-1 checkpoint inhibition or in combination with anti-CTLA-4 checkpoint inhibition.
- Age between 18 and 75 years at informed consent.
- ECOG performance status of 1 or less.
- Fit for tumor resection with at least one lesion larger than 1 cm3 available for surgery.
- At least one measurable tumor parameter per RECIST 1.1 criteria excluding the lesion to be removed.
- Left ventricular ejection fraction (LVEF) of 50% or higher.
- Sufficient organ function including specific blood counts and liver, kidney, and coagulation parameters.
- Signed informed consent.
- Willingness to participate in follow-up and handle potential toxicities.
- CRISPR-TIL as next therapy after tumor resection unless bridging therapy is used with required washout periods.
- Women of childbearing potential must have negative pregnancy tests and agree to use effective contraception during and after treatment.
- Men must be surgically sterile or agree to use contraception or abstinence during and after treatment.
You will not qualify if you...
- Recent treatments prior to tumor resection or lymphodepleting chemotherapy including cytotoxic chemotherapy, small molecules, immune therapy, corticosteroids above 10 mg prednisone equivalent, investigational treatments, and certain radiotherapies with specified washout periods.
- Prior T-cell therapy including gene therapy using integrating vectors.
- History of other malignancies unless disease-free for at least 2 years, with exceptions for certain skin and breast cancers.
- Patients with metastatic ocular, mucosal, or non-cutaneous melanoma (except unknown primary melanoma).
- Unresolved toxicity from previous cancer therapy above Grade 1 except stable or irreversible Grade 2 toxicities.
- More than 2 CNS metastases or symptomatic CNS lesions larger than 1 cm or with edema unless treated and stable for 2 months.
- Conditions preventing high-dose interleukin-2 therapy including certain heart and lung diseases.
- Known hypersensitivity to study drugs or excipients.
- Severe medical conditions such as severe asthma, significant cardiac disease, or poorly controlled diabetes.
- Creatinine clearance (eGFR) below 70 ml/min unless dose adjustment approved.
- Active infections including HIV, hepatitis, or syphilis.
- Severe allergies or history of anaphylaxis.
- Active autoimmune or immune-mediated diseases not resolved or requiring high-dose steroids.
- Pregnant or breastfeeding women.
- Unlikely to comply with study protocol requirements as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CCIT-DK
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
Research Team
J
Joel E Sohlin, MD
CONTACT
I
Inge Marie Svane, MD, phd, prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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