RAPA-201 Cell Therapy for Melanoma

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

65 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the RAPA-201 Cell Therapy treatment for melanoma?

The research highlights the potential of using T-cell-based immunotherapy, which involves using the body's immune cells to target melanoma cells, as a promising approach for treating melanoma. This includes the use of genetically modified T-cells to enhance their ability to recognize and attack melanoma cells, which is similar to the approach used in RAPA-201 Cell Therapy. ^{1 2 3 4 5}

How is the RAPA-201 treatment different from other melanoma treatments?

RAPA-201 is a cell therapy that uses genetically modified T cells to target melanoma cells by recognizing a specific antigen (a protein that triggers an immune response) called HMW-MAA, which is present on most melanomas. This approach is unique because it does not rely on the patient's specific genetic markers, making it potentially accessible to more patients compared to other therapies that require specific genetic matches. ^{2 6 7 8 9}

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.

Research Team

Daniel Fowler, M.D.

Principal Investigator

Rapa Therapeutics

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

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Generation of induced pluripotent stem cell (iPSC) from NY-ESO-I-specific cytotoxic T cells isolated from the melanoma patient with minor HLAs: The practical pilot study for the adoptive immunotherapy for melanoma using iPSC technology. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A high molecular weight melanoma-associated antigen-specific chimeric antigen receptor redirects lymphocytes to target human melanomas. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Increased frequency of suppressive regulatory T cells and T cell-mediated antigen loss results in murine melanoma recurrence. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Possibilities of immunotherapy and gene therapy for malignant melanoma. [2012]

5. England pubmed.ncbi.nlm.nih.gov

T-cell-based immunotherapy of melanoma: what have we learned and how can we improve? [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Adoptive T cell therapy using antigen-specific CD8+ T cell clones for the treatment of patients with metastatic melanoma: in vivo persistence, migration, and antitumor effect of transferred T cells. [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

mRNA expression of tumor-associated antigens in melanoma tissues and cell lines. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Generation of Induced Pluripotent Stem Cells from Human Melanoma Tumor-infiltrating Lymphocytes. [2018]

9. Slovakia pubmed.ncbi.nlm.nih.gov

The immunogenic properties of human melanomas and melanoma-associated antigens recognized by cytotoxic T lymphocytes. [2016]