Standardized Guidelines Are Needed to Collect Data and Counsel Patients Regarding CAR-T and Fertility

John Ligon, MD

Various types of treatments for cancers are known to have an impact on fertility. On the other hand, the impact of some treatment types, such as relatively new modalities like chimeric antigen receptor T-cell (CAR-T) therapy, are not well understood.

John Ligon, MD, an assistant professor in the department of pediatrics at the University of Florida College of Medicine, who is currently engaged in research on the topic of CAR-T and fertility, recently presented some of his and his colleagues findings at the 2024 Tandem Meetings |Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, held in San Antonio, Texas, February 21-24, 2024. In an interview with CGTLive®, Ligon discussed why evaluating the relationship between CAR-T therapy and fertility is important and the need for treatment centers to implement standard practices related to CAR-T and fertility.

CGTLive: Can you give some background information about your presentation at Tandem 2024?

John Ligon, MD: We've now been treating patients with cellular therapy and CAR T-cells for over 10 years. Up till now, these have largely been in patients with relapsed and refractory disease. Now, given the tremendous success, these treatments are coming to earlier and earlier in treatment paradigms. As such,it's becoming increasingly important for us to better understand the late effects of cellular therapy. One aspect of that that I'm particularly interested in is fertility because while immunotherapy has largely been considered to not impact fertility—because it's not alkylating treatment, it's not radiation, it's not really a transplant—it's largely unknown what the fertility outcomes are for these patients.

What were the key points you covered during your talk at the conference?

I think first of all, it's important to recognize that there are a number of reports that have come out about other kinds of immune therapies such as those with checkpoint inhibitors that show that several patients have had impaired sperm production after receiving just checkpoint inhibitors. So as we think about the mechanism of action of immune-based therapies, and how it really touches every part of our body and can lead to side effects diffusely throughout the body, it makes sense that you could also see immune-based therapies and CAR T-cells impacting fertility as well.

We reviewed one of our initial publications from about a year ago in Transplantation and Cellular Therapy where we asked several CIBMTR centers to tell us what outcomes they were aware of in terms of fertility and what their practices were about fertility counseling, fertility preservation, and pregnancy outcomes. What we found was that there were 7 pregnancies and 5 live births that were reported by various CIBMTR centers, which was very exciting. By and large, both male and female patients that they were able to tell us about had not needed to use assisted reproductive technologies. The 1 patient who did need to use assisted reproductive technologies was still able to use her own eggs so that was encouraging. Additionally, these patients were seeing fertility as early as 6 months after cell therapy so this was very interesting and encouraging.

The other piece that we uncovered, though, was that really there wasn't any kind of standardized guidance or practices about fertility across these centers. Most of these centers didn't have a particular guideline in place for how to counsel patients, how to monitor fertility with hormone levels after treatment, or when and how to refer patients for fertility preservation procedures. As an outcome from this study, especially now that cellular therapy is moving earlier in treatments, I think we do need to come together as a society and come up with some sort of standardized guidance that we can give patients and also prospectively try to collect data on patients who are receiving cellular therapy and their fertility outcomes. That way, we can come up with real evidence-based guidelines moving forward.

This transcript has been edited for clarity.

Click here for more coverage of Tandem 2024.

REFERENCES
1. Ligon JA. CAR T-cells and fertility. Presented at: 2024 Tandem Meetings, February 21-24, San Antonio, Texas.