CAR-T Meeting 2026 | Fertility management and outcomes in patients undergoing CAR T-cell therapy

I really would like to thank you for giving me the possibility to share the results that I’m presenting on behalf of all the authors that are indeed involved in this study. So we conducted a survey on behalf of the cellular therapy and the immunobiology working part of the EBMT in order to study and analyze the current outcomes of fertility in all the patients that received CAR T-cell therapies. We were very surprised that we indeed saw that more patients than we expected had some pregnancies after CAR T-cells. Particularly, we report here 23 pregnancies after CAR T-cells, and this is the largest report of pregnancies that have been reported. Moreover, we analyzed all the current practices and noticed that they are very different among the different centers, since there is still a lack of formal guidelines. So the survey characterized indeed in detail the clinical characteristics of the patients that had successful pregnancies, but also highlighted the need for standardized guidelines in this evolving field. 

So at the moment, there are a few studies that are indeed analyzing the long-term outcomes, in particular in gonadal function for patients that underwent CAR T-cells. In particular, there is a similar study dated 2022 involving American patients from the CIBMTR registry, and similarly, they report a few pregnancies after CAR T-cells, but there are no other large data. So indeed, our analysis is the first one reporting patients from the European centers. Compared to… there are indeed no trials comparing the efficacy, the effects on outcomes of conventional chemotherapy or the transplant field compared to CAR T-cell therapies. What we are indeed observing in our analysis is that the gonadal function seems to be preserved particularly in female patients. Indeed, the majority of the patients, the female patients that reported pregnancies have a spontaneous, so without the need of any assisted reproductive technologies, so it seems that at least in the cohort of patients that we reported, indeed, there is a preserved gonadal function. This is not the case in particular in the field of transplantation, in which we know that heavy chemotherapy cycles or a lot of previous numbers of chemotherapy do impact on the fertility outcome of patients. Moreover, we are moving in the CAR T-cell field also towards autoimmune diseases. So we have a completely new population of patients in which an early chemotherapy has not been administered to them. So we really would like to see what’s the impact in the future of also in the fertility field, which is very relevant in this very young cohort of patients. Moreover, a lot of patients have been treated in the pediatric age, so they are now aging. And we think that in the next future we will see a number of pregnancies in the patients treated when they were kids, and since CAR T-cells have a good efficacy in disease control, in particular in lymphoblastic leukemia, we think that in the next future some of those patients could indeed achieve pregnancies. 

Okay, so this was the last part of our survey, and we observed that there is a very different approach regarding these fields. The first difference is that a number of centers are administering only CAR-T therapy, while others are administering therapy from the beginning, from the diagnosis to the CAR T-cell field. And of course, the procedures of fertility are very different among these two different systems – of course, in Europe, we have some differences across the different countries. What we notice is that there’s still a lack of guidelines. So this work is highlighting this need – we really need a consensus of experts that could indeed determine which are the best technologies at the moment available. As I was mentioning before, a number of patients, in particular in the female population, did achieve pregnancies with no assistive procedures, but we do recommend, as always, to our patients to perform, cryopreservation, both in the male and female population, in order to have better fertility outcomes. But at the moment, we are unable to provide formal guidelines, and we really need to move this field on.

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