FDA Grants Fast Track Designation to IVS-3001 for Renal Cell Carcinoma


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The FDA has granted fast track designation IVS-3001 for use as a potential therapeutic option in patients with renal cell carcinoma.

Jake Kushner, MD

Jake Kushner, MD

The FDA has granted fast track designation IVS-3001 for use as a potential therapeutic option in patients with renal cell carcinoma (RCC), according to an announcement from Invectys, Inc.1

The decision is supported by findings from the investigational new drug application that had been submitted in December 2022 and was seeking the approval of a first-in-human, single-arm, open-label, phase 1/2 trial (NCT05672459) of the product.2,3

The key objectives of the research are to examine the safety, tolerability, pharmacokinetics, and early activity of the CAR T-cell therapy in patients with locally advanced unresectable or metastatic human leukocyte antigen A (HLA-G)–positive solid tumors who experienced failure with or who had been intolerant to standard treatment.

The effort, which is sponsored by The University of Texas MD Anderson Cancer Center, is being led by principal investigators Aung Naing, MD, professor of Investigational Cancer Therapeutics and Samer Srour, MD, assistant professor of Stem Cell Transplantation and Cellular Therapy, both of MD Anderson.2

“We are thrilled to receive the FDA’s fast track designation for IVS-3001,” Jake Kushner, MD, chief executive officer of Invectys, Inc., stated in a press release.1 “This recognition further validates the potential of our CAR T-cell therapy in revolutionizing cancer treatment for patients with solid tumors. The dedicated team at Invectys, as well as our partners, are committed to bringing this innovative therapy to the clinic and making a meaningful difference in the lives of [patients with] cancer.”

IVS-3001 is a third-generation CAR construct that permits anti–HLA-G CAR T cells to target and eliminate cells that express HLA-G.4 Preclinical data showed that the product can migrate to tumor sites and kill HLA-G–bearing cells in vivo. Specifically, mice who were treated with the CAR T-cell therapy exhibited almost total absence of tumor growth.

Notably, the product is not encumbered by immunosuppressive effects associated with the interaction of HLA-G and the ILT2 receptor. Moreover, because the CAR T cells target HLA-G, they disrupt the related immunosuppressive microenvironment created by the disease which allows for restored immune response. Because HLA-G is not expressed on healthy tissues, the incidence of on-target/off-tumor toxicities are hypothesized to be absent or limited.

The early-phase trial is recruiting patients with histologically or pathologically confirmed, locally advanced unresectable or metastatic solid tumors that are HLA-G positive. Patients need to be at least 18 years of age and must have experienced failure with or intolerance to standard treatments known to induce clinical benefit.3 Patients also needed to have measurable disease by RECIST v1.1 criteria, a life expectancy of longer than 12 weeks, and acceptable organ function.

The phase 2a portion of the trial is comprised of 3 cohorts: those with clear cell RCC, HLA-G positivity, who experienced failure with or intolerance to checkpoint inhibition and a TKI (cohort 1); those with epithelial ovarian carcinoma who experienced failure with or intolerance to platinum-based chemotherapy, or if they have BRCA1/2-mutated disease, PARP inhibitor failure or intolerance (cohort 2); and those with other HLA-G–positive cancers who experienced failure with or intolerance to at least 1 previous line of therapy and for whom no standard therapy is available per the judgment of the treating physician.

Patients with symptomatic, untreated or progressing central nervous system (CNS) metastases were excluded, as were those with primary CNS tumors. Other exclusion criteria included having a history of or presence of clinically relevant CNS pathology, if they were still experiencing adverse effects from a previous therapy that had not resolved to grade 1 or less, or if they had autoimmune disease, chronic infection, or another disease in need of immunosuppressive treatment.

Patients underwent leukapheresis where they received cyclophosphamide and fludarabine. They also received a single injection of IVS-3001 at the recommended phase 2 dose that will be established in the dose-escalation portion of the research.

For the first portion of the research, the key objective is to identify the safety, tolerability, and RP2D of the CAR T-cell therapy in those with relapsed or refractory solid tumors and HLA-G positivity. For the second portion, investigators will examine the antitumor activity of the project in these patients.

Important secondary objectives include assessing the pharmacokinetic profile of IVS-3001 in the form of persistence and expansion, the clinical activity of the product in select cohorts, and evaluating long-term safety. Investigators will also evaluate the functionality and immune biomarkers associated with response to the agent.


  1. FDA grants fast track designation to IVS-3001, a CAR T-cell therapy in the treatment of renal cell carcinoma. News release. Invectys, Inc. July 31, 2023. Accessed July 31, 2023. https://www.invectys.com/news/fda-grants-fast-track-designation-to-ivs-3001-invectys-car-t-cell-therapy-in-the-treatment-of-renal-cell-carcinoma/
  2. Invectys and CTMC announce FDA clearance of IND application for anti-HLA-G CAR T-cell therapy. News release. Invectys, Inc. December 20, 2022. Accessed July 31, 2023. https://www.invectys.com/news/invectys-and-ctmc-announce-fda-clearance-of-ind-application-for-anti-hla-g-car-t-cell-therapy/
  3. A safety and efficacy study of HLA-G- targeted CAR-T cells IVS-3001 in subjects with previously treated advanced HLA-G-positive solid tumors. ClinicalTrials.gov. Updated June 23, 2023. Accessed July 31, 2023. https://clinicaltrials.gov/study/NCT05672459
  4. IVS-3001: anti-HLA-G CAR T cells. Invectys, Inc. website. Accessed July 31, 2023. https://www.invectys.com/products-pipeline/ivs-3001-anti-hla-g-car-t-cells/
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