Study on the Safety and Effectiveness of A2B395 CAR T-Cell Therapy for Solid Tumors with Specific Genetic Markers
Sponsor: A2 Biotherapeutics Inc.
ClinicalTrials ID:NCT06682793
This clinical trial is testing a new treatment called A2B395, a type of CAR T-cell therapy, to see if it is safe and effective for patients with certain solid tumors that have specific genetic characteristics. The study focuses on cancers like colorectal, lung, head and neck, breast, and kidney cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate a new treatment called A2B395, which is a type of CAR T-cell therapy designed to target and kill cancer cells in patients with specific solid tumors. These tumors must express a protein called EGFR and have lost a genetic marker known as HLA-A*02. The study is divided into two phases: Phase 1 aims to find a safe dose of A2B395, while Phase 2 will test if this dose effectively kills cancer cells without harming healthy cells.
Description
This study involves testing a new treatment called A2B395, which is a CAR T-cell therapy designed to target specific cancer cells in patients with certain solid tumors. These tumors include colorectal, non-small cell lung, head and neck, triple-negative breast, and renal cell cancers, among others. The treatment is intended for patients whose tumors express a protein called EGFR and have lost a genetic marker known as HLA-A*02.
The study is conducted in two phases. Phase 1 focuses on determining a safe dose of A2B395, while Phase 2 evaluates the treatment's effectiveness in killing cancer cells and protecting healthy cells. Participants will undergo a preconditioning treatment to prepare their bodies for the CAR T-cell therapy. The study aims to provide a safer and more effective treatment option for patients with these types of cancers.
Participants must first enroll in a pre-screening study called BASECAMP-1 to confirm the genetic characteristics of their tumors. If eligible, they can then participate in this study, known as DENALI-1, without any waiting period between the two studies.
Eligibility Criteria
Inclusion Criteria
- Must be enrolled in the BASECAMP-1 study and have tumors with specific genetic characteristics confirmed by tests.
- Have a confirmed diagnosis of certain types of advanced or metastatic solid tumors, such as colorectal, lung, head and neck, breast, or kidney cancer.
- Have received previous standard treatments for their cancer.
- Have good organ function and a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of at least 3 months.
- Be willing to follow the study schedule and attend all follow-up appointments.
Exclusion Criteria
- Have cancer that can be treated with local therapy or standard treatments that are not just for symptom relief.
- Have had a previous stem cell or solid organ transplant.
- Have received cancer therapy or radiation recently before the study treatment.
- Have significant heart disease or recent heart problems.
- Have had a recent blood clot in the lungs or deep veins.
- Have a history of lung disease requiring long-term treatment.
- Require supplemental oxygen at home.
- Be pregnant or breastfeeding, or not willing to use birth control during and after the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCSD Moores Cancer Center | 92093 | La Jolla | California |
| UCLA Medical Center | 90404 | Los Angeles | California |
| Moffitt Cancer Center | 33606 | Tampa | Florida |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Washington Unversity | 63110 | St. Louis | Missouri |
| NYU Langone Medical Center | 10016 | New York | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.