Actively Recruiting
Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
39
Participants Needed
1
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find the highest tolerable dose and recommended dose of PRAME-TCR-NK cells that can be given to participants with recurrent and/or refractory melanoma. The safety and tolerability of PRAME-TCR-NK cells will also be studied.
CONDITIONS
Official Title
Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older.
- Participants must be willing and able to provide informed consent.
- Participants must have HLA A*02:01.
- Participants must have histologically confirmed locally advanced, unresectable, or metastatic melanoma that is relapsed or refractory to immune checkpoint inhibitor therapy including anti-PD-1 with or without anti-CTLA-4 or anti-LAG-3 antibodies.
- Participants should have received standard-of-care therapy per clinical guidelines.
- Participants must not have had more than 3 prior lines of anti-PD-1 antibody-containing therapies in the metastatic setting.
- Participants must have an ECOG performance status of 0 or 1.
- Participants must have a life expectancy of at least 3 months.
- Participants who received one or more prior systemic therapies are allowed.
- Female participants must be not of childbearing potential or agree to contraception during treatment and for 6 months post-infusion.
- Male participants must agree to contraception during treatment and for 6 months post-infusion.
- Women of childbearing potential must have a negative urine pregnancy test within 72 hours before lymphodepleting chemotherapy.
- Participants must have measurable disease per RECIST.
- Participants must have adequate organ function including left ventricular ejection fraction over 50% and adequate respiratory reserve (dyspnea Grade 0 or 1, oxygen saturation over 92% in room air).
- Participants must agree to mandatory blood collection and biopsies.
- Participants must agree to avoid live vaccines for at least 24 months post-infusion.
- Participants must consent to long-term follow-up on protocol PA17-0483.
You will not qualify if you...
- Pregnant, breastfeeding, or planning to conceive during the study period and for 6 months post-infusion.
- Received systemic anticancer therapy within 2 weeks or 5 half-lives before lymphodepleting chemotherapy; monoclonal antibody therapy must have been stopped at least 3 weeks prior.
- Not recovered from adverse events due to prior therapies above Grade 1, except certain Grade 2 events at investigator discretion.
- Received radiotherapy within 2 weeks before lymphodepleting chemotherapy and not fully recovered.
- Received a live vaccine within 6 weeks before infusion.
- Diagnosed with immunodeficiency or on chronic steroid therapy exceeding 10 mg prednisone daily.
- History of second malignancy unless treated curatively with no evidence for 2 years, except certain skin and in situ cancers.
- Active CNS metastases or carcinomatous meningitis; previously treated brain metastases allowed if stable and off steroids for 2 weeks.
- Active autoimmune disease requiring systemic treatment in past 2 years, except certain replacement therapies.
- Need for systemic immunosuppressive therapy or corticosteroid replacement.
- Symptomatic interstitial lung disease or lung disease interfering with treatment monitoring.
- Active infection including COVID-19, influenza, or sepsis; must be fully recovered before lymphodepletion.
- Known HIV infection or active hepatitis B or C infection.
- Conditions or treatments that could interfere with study participation or results.
- Psychiatric or substance abuse disorders interfering with cooperation.
- History of allogeneic tissue or solid organ transplant.
- Significant cardiovascular disease in past 12 months including severe heart failure, unstable angina, recent heart attack, stroke, or unstable arrhythmias.
- Prolonged QT interval over 480 milliseconds.
- Bleeding or clotting disorders or at risk of severe hemorrhage; stable patients on anticoagulation allowed.
- Elevated LDH more than 2.5 times upper limit of normal at screening.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
Isabella C Glitza Oliva, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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