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ASCO 2025 | Phase I/IIa trial of IVS-3001, a HLA-G-targeting CAR T-cell therapy, in solid tumors

Samer Srour, MB ChB, MS, The University of Texas MD Anderson Cancer Center, Houston, TX, comments on an ongoing Phase I/IIa trial (NCT05672459) investigating IVS-3001, a novel autologous CAR T-cell therapy targeting HLA-G, an immune checkpoint molecule overexpressed in various solid tumors. The study assesses safety, pharmacokinetics, and early efficacy in patients with previously treated, advanced HLA-G–positive solid tumors. IVS-3001 is designed to enhance T-cell activation and persistence in the immunosuppressive tumor microenvironment. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

This year at ASCO 2025, we are presenting our trial in progress for IVS-3001. This is a very interesting CAR product targeting HLA-G. HLA-G is really a unique target. It’s normally expressed or physiologically expressed during pregnancy around the placenta, and its role is indeed to protect the baby from the immune system of the mother. So the mother can feed the baby without, you know, attacking the baby and the baby would grow...

This year at ASCO 2025, we are presenting our trial in progress for IVS-3001. This is a very interesting CAR product targeting HLA-G. HLA-G is really a unique target. It’s normally expressed or physiologically expressed during pregnancy around the placenta, and its role is indeed to protect the baby from the immune system of the mother. So the mother can feed the baby without, you know, attacking the baby and the baby would grow. So over years we found that the HLA-G can be expressed over certain tumors or many tumors indeed. One of them, one of the most common tumors we see it in is RCC, renal cell carcinoma. Also choriocarcinomas, these are, this is a type of germ cell tumors highly expressed in those tumors, in addition to ovarian and some GI cancers and many other cancers. So the idea here is HLA-G, when it’s aberrantly expressed over the tumor cells, it can protect the tumor like it protects the baby in the normal physiologic pregnancy from the immune system of the patient. And it can really help the progression of the tumor. So, to that point, we have developed this IVS-3001, and this is the first in human phase one clinical trial for CAR-T Cell targeting HLA-G-positive solid tumors. We have already launched the study in the clinic, and as we speak today, we treated our first patient on dose level four. We’re very excited, hopefully next year, to see some promising results from this clinical trial, ongoing clinical trial.

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