Study on RAPA-201 Therapy for Solid Tumors

Sponsor: Rapa Therapeutics LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05144698

Provider View

This clinical trial is testing a new treatment called RAPA-201, which uses a type of immune cell therapy to help fight solid tumors that have not responded to previous treatments. The study aims to see if this approach can improve outcomes for patients with advanced cancers.

Patient Parameters

Program Overview

This study is exploring a new treatment for solid tumors using RAPA-201, a type of immune cell therapy. RAPA-201 involves using a patient's own immune cells, which are modified to better fight cancer. The study will test if this treatment, combined with standard chemotherapy drugs carboplatin and paclitaxel, can help control tumors that have not responded to other therapies. The trial will include up to 22 patients with advanced cancers that have returned or not responded to previous treatments, including those that have not worked with anti-PD-1 therapies.

Description

This clinical trial is testing a new immune therapy called RAPA-201 for treating solid tumors. RAPA-201 uses a patient's own immune cells, which are modified to better attack cancer cells. These cells are designed to be more effective in the challenging environment of a tumor. The study will combine RAPA-201 with standard chemotherapy drugs, carboplatin and paclitaxel, which are known to help the immune system fight cancer. The trial will include patients with various types of advanced cancers, such as lung, breast, gastric, head and neck, bladder cancer, and melanoma, that have not responded to previous treatments. The treatment involves six cycles of chemotherapy, with RAPA-201 cells given during cycles 2 to 6. The study aims to see if this combination can improve outcomes for patients whose cancers have not responded to other therapies.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Good overall health with a performance status of 2 or less.
  • Have advanced solid tumors that have returned after at least one previous treatment.
  • Have tried standard treatments that are known to help their type of cancer, or have refused such treatments.
  • Have received a previous treatment with an anti-PD-1 therapy.
  • Have a tumor type suitable for chemotherapy with carboplatin and paclitaxel.
  • Have measurable disease that can be monitored.
  • Have enough immune cells in the blood to create RAPA-201 cells.
  • Have recovered from any side effects of previous treatments.
  • Have normal heart, kidney, and liver function as shown by specific tests.
  • Agree to use contraception if of childbearing potential.
  • Provide written consent to participate in the study.

Exclusion Criteria

  • Have another active cancer, except for non-melanoma skin cancer.
  • Have a life expectancy of less than 4 months.
  • Have uncontrolled infections like HIV, hepatitis B, or hepatitis C.
  • Have uncontrolled high blood pressure.
  • Have had a stroke or heart attack in the last 6 months.
  • Have severe heart failure or unstable heart disease.
  • Have cancer that has spread to the brain, unless treated.
  • Are pregnant or breastfeeding.
  • Are unwilling to use contraception if of childbearing potential.
  • May be excluded for medical or psychiatric reasons at the discretion of the study doctor.

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