RAPA-201 Cell Therapy for Melanoma

Not yet recruiting at 1 trial location

Overseen By Daniel Fowler, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rapa Therapeutics LLC

Must be taking: Anti-PD-(L)1, BRAF inhibitors

Disqualifiers: Other malignancy, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cell therapy called RAPA-201 for individuals with advanced melanoma, a type of skin cancer that has returned or resisted previous treatments involving anti-PD-(L)1 therapy. The trial will determine if this treatment can manage the condition when other options have failed. It suits those whose melanoma cannot be surgically removed and who have not responded to certain cancer therapies. Participants should have undergone frequent treatments without success and still have measurable disease for monitoring. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering hope for those seeking new options.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be at least two weeks from your last cancer treatment, surgery, or participation in other trials.

Is there any evidence suggesting that RAPA-201 is likely to be safe for humans?

Research shows that RAPA-201, a type of cell therapy, is being tested for its safety and effectiveness in treating advanced melanoma, a serious skin cancer. Earlier studies have shown encouraging results. For example, when RAPA-201 was used in other types of solid tumors, it helped control the disease in 60% of patients, and all patients experienced some level of disease control. Importantly, this treatment was safely administered in an outpatient setting, allowing patients to avoid overnight hospital stays.

In another study, RAPA-201 safely managed disease in patients with multiple myeloma, a type of blood cancer, after they underwent treatment to lower their white blood cells. These results suggest that the therapy is generally well-tolerated. However, since this is a phase 2 trial, more research is needed to fully understand the safety of RAPA-201 for patients with melanoma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for melanoma?

Unlike the standard treatments for melanoma, which often include surgery, chemotherapy, or targeted therapies, RAPA-201 is a cell therapy that uses a unique approach. This treatment involves administering a specific dose of RAPA-201 cells directly to the patient. These cells are designed to target and potentially enhance the body's immune response against melanoma cells. Researchers are excited about RAPA-201 because it represents a novel way to harness and amplify the body's natural defenses, offering hope for improved effectiveness and reduced side effects compared to conventional therapies.

What evidence suggests that RAPA-201 might be an effective treatment for melanoma?

Research has shown that RAPA-201 cell therapy, which participants in this trial will receive, could be promising for treating advanced melanoma. In earlier studies, 60% of melanoma patients responded positively to the treatment. Another study found that 64% of patients experienced some level of disease remission, with improvements ranging from partial to complete recovery. These results suggest that RAPA-201 might be effective for patients whose cancer hasn't responded to other treatments. The therapy uses specially designed T-cells, a type of immune cell, to find and attack cancer cells, offering new hope for those with advanced melanoma. ^{1 3 6 7 8}

Who Is on the Research Team?

Daniel Fowler, M.D.

Principal Investigator

Rapa Therapeutics

Are You a Good Fit for This Trial?

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

Bilirubin ≤ 2.0 mg/dL (if Gilbert's disease, ≤ 3.0 mg/dL)

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

It's been over two weeks since my last cancer treatment or surgery.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RAPA-201 cell therapy for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• RAPA-201

Trial Overview 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.

How Is the Trial Designed?

Group I: Administration of RAPA-201 cells Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Rapa Therapeutics LLC

Lead Sponsor

Trials

6

Recruited

200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06708455?term=AREA%5BConditionSearch%5D(pd%201%20OR%20%22patent%20ductus%20arteriosus,%20susceptibility%20to%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=9

Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 ... A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/559100

Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L) In an intent-to-treat (ITT) manner, the efficacy of RAPA-201 cell therapy will be determined by overall response rate (ORR) in metastatic melanoma patients with ...

3. trials.braintumor.org trials.braintumor.org/trials/NCT06708455

Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L) Initial results on the first RAPA-201 clinical trial in solid tumors (NCT05144698) demonstrated that six out of 10 evaluable melanoma patients (60%) responded ...

4. withpower.com withpower.com/trial/phase-2-melanoma-2-2025-7cf5c

RAPA-201 Cell Therapy for Melanoma · Info for Participants What data supports the effectiveness of the RAPA-201 Cell Therapy treatment for melanoma? The research highlights the potential of using T-cell-based ...

5. jitc.bmj.com jitc.bmj.com/content/13/1/e010649

Rapamycin-resistant polyclonal Th1/Tc1 cell therapy ... Nine of 14 patients (64%) achieved disease remission, with eight partial responses and one stringent complete response. Median progression-free ...

6. cancer.gov cancer.gov/clinicaltrials/NCI-2022-01928

RAPA-201 Therapy of Solid Tumors - NCI RAPA-201 cells will be administered at a target flat dose of 400 X 10^6 cells per infusion on day 3 of cycles 2 through 6. In the original protocol design, a ...

7. nature.com nature.com/articles/d43747-023-00094-0

Rapa's epigenetic reprogramming creates T cell therapies ... RAPA-201 has safely achieved, exclusively through outpatient therapy, a 60% overall response rate (ORR) and 100% disease control rate in solid tumor patients ...

8. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A818

723 Metabolically reprogrammed autologous Th1/Tc1 cell ... RAPA-201 safely mediates disease remissions in multiple myeloma when administered after lymphodepleting conditioning.