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CAR T-cell Therapy
RAPA-201 Cell Therapy for Melanoma
Phase 2
Waitlist Available
Research Sponsored by Rapa Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months
Prior therapy with a BRAF inhibitor alone or in combination with a MEK inhibitor for patients with BRAF V600 mutation-positive tumors
Must not have
NYHA class III/IV congestive heart failure
Uncontrolled angina/ischemic heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one (1) year after the last dose of rapa-201 cells.
Awards & highlights
No Placebo-Only Group
Summary
This trial is for patients with advanced melanoma that has come back after previous treatment. It will be done at multiple sites and will have two stages to test the effectiveness of a new treatment.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of RAPA-201 cell therapy may include reactions at the infusion site, flu-like symptoms, fatigue, fever and chills. Chemotherapy could cause nausea, hair loss, mouth sores and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly active and my doctors expect me to live for at least 3 more months.
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I have been treated with a BRAF inhibitor for my BRAF V600 mutation-positive tumor.
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My kidneys are functioning well enough to clear waste.
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My last cancer treatment, including an anti-PD-(L)1 drug, did not work.
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I do not have a history of unusual bleeding.
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My melanoma cannot be removed by surgery and is advanced.
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My liver tests are within the normal range, even with liver metastasis.
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My heart pumps well, with an ejection fraction of 45% or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe heart failure.
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I have uncontrolled chest pain due to heart disease.
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I do not have any active cancer except for non-melanoma skin cancer.
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My cancer has spread to my brain or spinal cord but has been treated.
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My blood pressure is not controlled by medication.
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I have not had a stroke in the last 6 months.
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I have not had a heart attack in the last 6 months.
Select...
I am not willing to use birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one (1) year after the last dose of rapa-201 cells.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one (1) year after the last dose of rapa-201 cells.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of RAPA-201 Cell Therapy
Secondary study objectives
Characterize RAPA-201 Efficacy
Quality of Life (QOL)
Safety of RAPA-201 Cell Therapy
Other study objectives
Immune Reconstitution
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Find a Location
Who is running the clinical trial?
Rapa Therapeutics LLCLead Sponsor
5 Previous Clinical Trials
131 Total Patients Enrolled
Daniel Fowler, M.D.Study DirectorRapa Therapeutics
4 Previous Clinical Trials
91 Total Patients Enrolled