Study on Zevor-cel (CT053) for Patients with Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: CARsgen Therapeutics Co., Ltd.
ClinicalTrials ID:NCT03915184
This clinical trial is testing a new treatment called Zevor-cel (CT053) for patients with multiple myeloma that has returned or is not responding to other treatments. The study aims to evaluate the safety and effectiveness of this therapy.
Patient Parameters
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Program Overview
This study is exploring a new treatment for multiple myeloma, a type of blood cancer, using a therapy called Zevor-cel (CT053). This treatment involves modifying a patient's own immune cells to better target and fight the cancer. The trial is divided into two phases: Phase 1b will determine the best dose, and Phase 2 will test its effectiveness. Participants will undergo a procedure to collect their immune cells, which will be modified in a lab and then returned to their body. After receiving the treatment, participants will be monitored for a long-term follow-up period of 15 years to assess the treatment's impact and safety.
Description
This clinical trial is testing a new treatment called Zevor-cel (CT053) for patients with multiple myeloma that has returned or is not responding to other treatments. The study aims to evaluate the safety and effectiveness of this therapy. Participants will have their immune cells collected and modified in a lab to better target the cancer. These modified cells will then be infused back into the patient after a preparatory treatment. The trial is divided into two phases: Phase 1b will determine the best dose, and Phase 2 will test its effectiveness. Participants will be monitored for a long-term follow-up period of 15 years to assess the treatment's impact and safety.
Eligibility Criteria
Inclusion Criteria
- Must voluntarily agree to participate and sign a consent form.
- Aged between 18 and 79 years.
- Have received enough previous treatments for multiple myeloma.
- Have been treated with at least one proteasome inhibitor, one IMiD, and a CD38 antibody.
- The cancer must not have responded to the last treatment.
- Must have measurable disease according to specific medical guidelines.
- Expected to live for more than 12 weeks.
- Must be in good general health with a performance score of 0 or 1.
- Must have adequate blood counts and kidney and liver function.
- Must have suitable veins for the cell collection procedure and no issues that would prevent this procedure.
- Women of childbearing age must test negative for pregnancy and agree to use effective birth control for at least 12 months after treatment.
- Men must agree to use effective birth control for at least 12 months after treatment.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Have active infections like HIV, hepatitis C, or hepatitis B.
- Have any uncontrolled active infection.
- Have not recovered from side effects of previous treatments.
- Have had previous anti-BCMA therapy.
- Have graft versus host disease (GvHD).
- Have had a stem cell transplant within a year before cell collection.
- Have received any cancer treatment before cell collection.
- Have taken steroids before cell collection or preparatory treatment.
- Have certain other blood disorders or conditions like plasma cell leukemia or Waldenström macroglobulinemia.
- Have received a live vaccine before cell collection or preparatory treatment.
- Are allergic to certain medications used in the study.
- Have significant heart or lung conditions.
- Have active autoimmune diseases requiring long-term immunosuppressive therapy.
- Have another type of cancer besides multiple myeloma.
- Have cancer that has spread to the brain or nervous system.
- Have significant neurological disorders.
- Are unable or unwilling to follow the study requirements.
- Have had major surgery before cell collection or preparatory treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital | 85054 | Phoenix | Arizona |
| UCSF | 94143 | San Francisco | California |
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Dana Farber Cancer Center | 02215 | Boston | Massachusetts |
| Mayo | 55905 | Rochester | Minnesota |
| TriStar CMC | 37203 | Nashville | Tennessee |
| UT Southwestern Medical Center | 76021 | Dallas | Texas |
| MD Anderson | 77030 | Houston | Texas |
| Methodist Hosptial | 77030 | Houston | Texas |
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