A New BCMA CAR T for Relapsed/Refractory Myeloma in Phase I Clinical Trial

While we have two autologous BCMA-targeting CAR T cell therapies already FDA approved (Abecma and Carvykti), work continues by other comapnies to develop additional CAR T therapies going after the same target. 

About the Zevor-Cel Study

 In a recent HealthTree Pocast with Jesus Berdeja, MD, a clinical trial from CARgen Therapeutics was mentioned. The product is called zevor-cel and it is now in a Phase 1b/2 study. In the Phase 1b portion of the study, the safety and efficacy of zevor-cel will be evaluated in patients with relapsed or refractory myeloma. After the ideal dose is identified in the Phase 1b portion, the Phase 2 portion will open. 

In the study, accepted patients will have their T cells collected using a process called leukapheresis. After the CAR T product is manufactured based on each patient's individual T cells, the cells will be returned to the facility. Before receiving the customized CAR T cell therapy, patients will receive a pre-conditioning chemotherapy (called lymphodepletion). After the study, patients will participate in a 15-year follow-up. 

This study is looking for three primary outcomes: 

1. Incidence of treatment-related adverse events or side effects and serious adverse events
2. Identification of maximum tolerated dose and Incidence of dose-limiting toxicities
3. Objective response rate

Secondary outsomes will also be reviewed that include: 

• Time to response, time to progression, progression-free survival, best response, and overall survival
• The efficacy of treatment, time to response, progression, and best tumor response
• The percentage of patients with anti-zevor-cel drug antibodies
• The use of hospital resources and duration of hospitalization and ICU.

The study is currently open and recruiting at least 105 patients that fit the following criteria:

• Man or Woman with age between 18 and 80 years
• Received sufficient prior lines of myeloma therapy and refractory to the last line of therapy
• Received treatment with at least one proteasome inhibitor, one IMiD and CD38 antibody
• Measurable disease per IMWG definition
• ECOG performance score 0-1
• Reasonable CBC counts, renal and hepatic functions
• Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis
• Estimated life expectancy > 12 weeks

Study Sites

The study is open at Mayo Clinic in Scottsdale, UCSF, Colorado Blood Cancer Institute, Moffitt Cancer Center, Dana Farber, University of Michigan, Mayo Clinic Rochester, TriStar CMC, UT Southwestern, MD Anderson Cancer Center, Methodist Hospital (Houston), Huntsman Cancer Institute, Medical College of Wisconsin and Princess Margaret Hospital (Canada). 

How CAR T Therapy Works

How does CAR T cell therapy work? In this HealthTree University class, Djordje Atanackovic, MD of the University of Maryland explains that, unlike some other myeloma treatments, CAR-T is a specific therapy with a local approach: “just like the process your body would normally do to kill a virus, but in this case, it intends to kill the Myeloma cell itself.” 

Current CAR T cell therapy clinical trials are for patients in later lines of therapy - those who have relapsed after treatment or become refractory to treatment (learn more about refractory myeloma in this HealthTree University class).

We look forward to their use in earlier lines of treatment and eventually believe they will be tested and used in newly diagnosed patients.

How We Can Help

Did you know you can use our Clinical Trial Finder to explore trials you may qualify for based on your specific criteria? If you need assistance navigating the tool, our Patient Navigator support team is here to help. You can reach us at 800-709-1113 or email support@healthtree.org.