Phase 2b Study of RAPA-201 Cell Therapy for Melanoma After PD-(L)1 Treatment

Sponsor: Rapa Therapeutics LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06708455

Provider View

This clinical trial is testing a new cell therapy called RAPA-201 for patients with advanced melanoma that has not responded to previous PD-(L)1 treatments. The study aims to see if this therapy can help control the cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment called RAPA-201 for patients with advanced melanoma that has come back or not responded after previous treatments with PD-(L)1 inhibitors. RAPA-201 is a type of immunotherapy that uses specially modified T cells from the patient's own blood to target and attack cancer cells. The trial will evaluate how well this treatment works and its safety in patients whose melanoma has not responded to other therapies.

Description

RAPA-201 is a new type of immunotherapy that uses the patient's own T cells, which are a part of the immune system, to fight cancer. These T cells are collected from the patient, modified in a lab to enhance their ability to attack cancer cells, and then returned to the patient. This therapy is being tested in patients with melanoma that has not responded to previous treatments with PD-(L)1 inhibitors.

The RAPA-201 cells are designed to be more effective in the tumor environment by having several key features:

  1. They are programmed to attack cancer cells more effectively.
  2. They have a memory feature that helps them stay active in the body longer.
  3. They are resistant to certain drugs, allowing them to survive better in the body.
  4. They are less likely to cause severe side effects related to immune system overactivity.
  5. They have fewer inhibitory receptors, which helps them work better in the cancer environment.

The study will focus on patients with melanoma that has not responded to PD-(L)1 treatments, aiming to see if RAPA-201 can help control the cancer. The trial will also assess the safety of this treatment and its potential to be combined with other cancer therapies.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Good overall health with a life expectancy of at least 3 months.
  • Have advanced melanoma that cannot be removed by surgery or has spread.
  • Have not responded to previous PD-(L)1 treatments or relapsed within 12 months of starting such treatment.
  • If the tumor has a BRAF V600 mutation, must have tried BRAF inhibitors.
  • Have measurable cancer that can be tracked during the study.
  • Have enough T cells in the blood to create the RAPA-201 therapy.
  • At least two weeks since last cancer treatment or surgery.
  • Recovered from any side effects of previous immunotherapy.
  • Meet specific blood and organ function criteria.
  • Agree to provide written consent to participate in the study.

Exclusion Criteria

  • Have another active cancer, except for non-melanoma skin cancer.
  • Life expectancy less than 3 months.
  • Have HIV, hepatitis B, or hepatitis C unless well-controlled.
  • Have uncontrolled high blood pressure.
  • Have had a stroke or heart attack in the last 6 months.
  • Have severe heart disease.
  • Have cancer that has spread to the brain unless treated.
  • Are pregnant or breastfeeding.
  • Are not willing to use contraception if of childbearing potential.
  • May be excluded for other medical or psychiatric reasons at the discretion of the study doctor.

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