PRAME-TCR-NK Cells for Melanoma

Recruiting in 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.

Research Team

Adi Diab

Principal Investigator

M.D. Anderson Cancer Center

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 willing to have blood tests and biopsies.

Participants must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST)

I agree not to get a live vaccine for 2 years after my treatment.

See 11 more

Exclusion Criteria

Not recovered from all adverse events due to previous therapies

Psychiatric or substance abuse disorders that would interfere with study cooperation

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

See 17 more

Treatment Details

Interventions

PRAME T Cell Receptor (TCR) Engineered NK Cells (CAR T-cell Therapy)

Trial OverviewResearchers 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.

Participant Groups

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.