PRAME-TCR-NK Cells for Melanoma

Palo Alto (17 mi)

Overseen byAdi Diab

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people with melanoma that has come back or hasn't responded to treatment. Participants must meet certain health requirements, which will be specified by the researchers conducting the study.

Inclusion Criteria

I am 18 years old or older.

My genetic makeup includes HLA A*02:01.

My melanoma cannot be removed by surgery and has not responded to immune therapy.

I am fully active or restricted in physically strenuous activity but can do light work.

I am following the required contraceptive guidelines.

Exclusion Criteria

I had radiotherapy less than 2 weeks before starting chemotherapy that lowers my immune cell counts.

I have not received a live vaccine in the last 6 weeks.

I need medication to suppress my immune system or replace corticosteroids.

I have active brain metastases or carcinomatous meningitis.

I have had another type of cancer in the past 2 years.

I have a bleeding or clotting disorder, or I'm at high risk for serious bleeding.

I have been treated for an autoimmune disease in the last 2 years.

I have HIV or active hepatitis B or C.

I have symptoms from lung scarring.

I do not have an active infection like COVID-19 or the flu.

I have an immune system disorder or I'm on long-term steroids.

I have received an organ or tissue transplant from another person.

Treatment Details

Researchers are testing PRAME-TCR-NK cells at various doses to find the highest dose patients can tolerate without severe side effects. They're also looking for a recommended safe dose and assessing overall safety.

2Treatment groups

Experimental Treatment

Group I: Expansion PhaseExperimental Treatment2 Interventions

Participants will receive PRAME-TCR-NK cells at the recommended dose.All participants will receive the same dose level of fludarabine and cyclophosphamide

Group II: Escalation PhaseExperimental Treatment2 Interventions

The dose of PRAME-TCR-NK cells you receive will depend on when you join this study. Up to 5 dose levels of the study product will be tested. The first group of participants will receive the lowest dose level of the study product. Each new group will receive a higher dose of the study product than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose and recommended dose of the study product is found.