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 (NCT05672459)
🩺 Plain-English Summary (8th-Grade Level)
The proposed clinical study is a Phase 1/2a trial to investigate the safety, tolerability, pharmacokinetics and clinical activity of anti-HLA-G CAR-T cells IVS-3001 administered to subjects with previously treated, locally advanced, or metastatic solid tumors which are HLA-G positive (HLA-G+) - as determined by immunohistochemistry (IHC) analysis on tumor biopsies using the 4H84 antibody.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (30 items) and avoid the listed exclusions (32 items).
Location: M D Anderson Cancer Center — Houston, Texas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Subjects who meet any of the following criteria are NOT eligible for the study.
- Immunotherapy at enrollment and after. Note: Bridging therapies (including herbal therapies) other than immunotherapies are allowed from cell harvest to 2 weeks before lymphodepletion (5 weeks for nitrosoureas or mitomycin) or 5 half-lives, whichever is shorter and must be reported in the CRF. Palliative radiotherapy is permitted but treatment must be completed at least 2 weeks prior to the start of lymphodepletion.
- Symptomatic, untreated, or actively progressing central nervous system metastases (subjects with prior brain metastases treated at least 2 weeks prior to the planned IVS-3001 infusion who are clinically stable and do not require chronic corticosteroid treatment are allowed.
- Primary CNS tumors.
- History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or leptomeningeal disease.
- Ongoing toxicities related to prior anticancer therapy that have not resolved to Grade ≤ 1 (other than alopecia). Note: Current unresolved Grade ≥ 2 non-hematologic toxicity may be allowed after discussing with the study Chair/Co-Chair.
- Participation in any investigational drug study within 4 weeks prior to cell infusion.
- Autoimmune disease, chronic infection or any disease requiring systemic immunosuppressive therapy (e.g., calcineurin inhibitors, methotrexate, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6-receptor).
- Prior CAR T cell or other genetically modified T cell therapy.
- Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- Symptomatic congestive heart failure requiring treatment.
- Clinically significant cardiac arrhythmia.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- M D Anderson Cancer Center — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.