A Phase I Study of Alpha-1,3-Galactosyltransferase-Expressing Allogeneic Renal Cell Carcinoma Immunotherapy in Patients with Refractory Metastatic Renal Cell Carcinoma
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Le résumé fourni par la source
LESSONS LEARNED: HyperAcute Renal immunotherapy was well tolerated and demonstrated antitumor activity in patients requiring salvage-line treatment for metastatic renal cell carcinoma (mRCC). HyperAcute Renal immunotherapy was safely administered with concomitant salvage-line treatments for mRCC, and it may be a candidate for inclusion in novel combinations for salvage treatment of mRCC because of its unique mechanism of action. BACKGROUND: HyperAcute Renal (HAR) immunotherapy exploits a naturally occurring barrier to xenotransplantation and zoonotic infections in humans to immunize patients against metastatic renal cell carcinoma (mRCC) cells. HAR consists of two allogeneic renal cancer cell lines genetically modified to express α(1,3)Gal, to which humans have an inherent pre-existing immunity. METHODS: Patients with refractory mRCC were eligible for this phase I dose-escalation trial. Concomitant treatment was permitted after the initial 2 months of HAR monotherapy. HAR was injected intradermally weekly for 4 weeks then biweekly for 20 weeks, totaling 14 immunizations. The primary endpoint was safety and determination of a maximum tolerated dose (MTD). RESULTS: Among 18 patients enrolled, two grade 3 adverse events (AEs) were attributed to HAR, lymphopenia and injection site reaction, and no grade 4/5 AEs occurred. The recommended phase II dose (RP2D) was 300 million cells. One patient had a partial response and eight patients had stable disease, for a disease control rate of 50% (9/18). Median overall survival with low-dose HAR was 14.2 months and was 25.3 months with high-dose HAR. CONCLUSION: In pretreated mRCC, HAR immunotherapy was well tolerated and demonstrated antitumor activity. HAR immunotherapy may be a candidate for inclusion in novel combinations for salvage treatment of mRCC.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- A Phase I Study of Alpha-1,3-Galactosyltransferase-Expressing Allogeneic Renal Cell Carcinoma Immunotherapy in Patients with Refractory Metastatic Renal Cell Carcinoma
- Date Crossref
- 06/09/2019
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Utah Department of Internal Medicine pays non établi dans la noticeUniversité ou école supérieure
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Huntsman Cancer Institute pays non établi dans la noticeÉtablissement de santé
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Columbia University Irving Medical Center pays non établi dans la noticeÉtablissement de santé
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Texas Health Dallas pays non établi dans la noticeÉtablissement de santé
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Sidney Kimmel Comprehensive Cancer Center pays non établi dans la noticeStructure de recherche
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University of Iowa Holden Comprehensive Cancer Center pays non établi dans la noticeUniversité ou école supérieure
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NewLink Genetics (United States) pays non établi dans la noticeEntreprise
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Southwestern Medical Center Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
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The University of Texas Southwestern Medical Center pays non établi dans la noticeÉtablissement de santé
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Columbia University Medical Center Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Department of Oncology pays non établi dans la noticeInstitution
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NewLink Genetics Corporation pays non établi dans la noticeInstitution
Department of Internal Medicine — University of Utah, Huntsman Cancer Institute et Columbia University Irving Medical Center, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.