RAPA-201 Cell Therapy for Melanoma

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Rapa Therapeutics LLC

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The protocol is a Simon's 2-stage, non-randomized, open label, multi-site, phase 2 trial for patients with advanced metastatic, recurrent and unresectable malignant melanoma that has recurred or relapsed after prior anti-PD-(L)1 therapy.

Eligibility Criteria

This trial is for adults with advanced melanoma that came back or didn't respond after anti-PD-(L)1 therapy. Participants must have measurable disease, be willing to undergo biopsies, and have recovered from previous treatments. They can't join if they're pregnant, breastfeeding, have an active infection or autoimmune disease, or are currently receiving other cancer therapies.

Inclusion Criteria

I am mostly active and my doctors expect me to live for at least 3 more months.

I have been treated with a BRAF inhibitor for my BRAF V600 mutation-positive tumor.

My kidneys are functioning well enough to clear waste.

My last cancer treatment, including an anti-PD-(L)1 drug, did not work.

I do not have a history of unusual bleeding.

My melanoma cannot be removed by surgery and is advanced.

My liver tests are within the normal range, even with liver metastasis.

My heart pumps well, with an ejection fraction of 45% or higher.

Exclusion Criteria

I have severe heart failure.

I have uncontrolled chest pain due to heart disease.

I do not have any active cancer except for non-melanoma skin cancer.

My cancer has spread to my brain or spinal cord but has been treated.

My blood pressure is not controlled by medication.

I have not had a stroke in the last 6 months.

I have not had a heart attack in the last 6 months.

I am not willing to use birth control.

Treatment Details

The study tests RAPA-201 cell therapy in patients who've had melanoma return after PD-(L)1 treatment. It's a phase 2 trial where all participants receive the same treatment without being randomly assigned to different groups.

1Treatment groups

Experimental Treatment

Group I: Administration of RAPA-201 cellsExperimental Treatment2 Interventions

RAPA-201 cells will be administered at a target flat dose between 80 and 400 x 10\^6 cells per infusion.