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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

A Phase 1/2a, 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•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Primary Objectives: IVS-3001 is an autologous CAR-T cell therapy targeting human leukocyte antigen (HLA-G) * Phase 1: To determine the safety, tolerability and the recommended phase 2 dose (RP2D) of IVS-3001 in subjects with refractory or relapsed HLA-G+ solid tumors. * Phase 2a: To evaluate the anti-tumor activity of IVS-3001 in selected HLA-G+ solid tumor types. Secondary Objectives: * To evaluate pharmacokinetic profile of IVS-3001: persistence, expansion. * To evaluate the clinical activity of IVS-3001 in selected HLA-G+ solid tumor types. * To assess the long-term safety of IVS-3001. Exploratory Objectives: • To explore functionality of IVS-3001 as well as immune biomarkers linked with IVS-3001 and their relationship with clinical response

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years old.
•2. Histologically or pathologically confirmed diagnosis of a locally advanced unresectable or metastatic HLA-G+ select solid tumor malignancy who failed or intolerant to standard of care therapies known to confer clinical benefit per treating physician.
•For Phase 2a, eligible subjects will be enrolled into indication-specific cohorts:
•1. Cohort 1: HLA-G+ clear cell renal cell carcinoma who failed or intolerant to checkpoint inhibitor (CPI) and tyrosine kinase inhibitor (TKI)
•2. Cohort 2: Epithelial ovarian carcinoma who failed or intolerant to platinum-based therapy, and should have failed or intolerant for PARP inhibitor if BRCA 1/2 mutated
•3. Cohort 3: Other HLA-G+ tumors (biomarker driven) who failed or intolerant to at least one prior line of therapy and for whom at discretion of treating physician there is no standard therapy to confer a clinical benefit
•3. HLA-G expression on tumor cells (any level of expression is acceptable) as determined by immunohistochemistry (IHC) analysis on tumor biopsies using the 4H84 antibody \[1, 2\]
•4. Measurable disease (at least one target lesion) per RECIST v1.1 \[3\]
•5. Life expectancy \>12 weeks.
•6. Availability of a pre-treatment tumor archived tissue specimen to test for HLA-G expression.
+22 more criteria

Exclusion Criteria

•1. 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.
•2. 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.
•3. Primary CNS tumors.
•4. 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.
•5. 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.
•6. Participation in any investigational drug study within 4 weeks prior to cell infusion.
•7. 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).
•8. Prior CAR T cell or other genetically modified T cell therapy.
•9. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
+23 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

June 21, 2023

Primary Completion Date

June 29, 2026

Completion Date

December 29, 2029

Last Updated

February 25, 2026

Enrollment

ACTUAL participants

Conditions

Solid Tumor

Interventions

Single Injection of IVS-3001- Anti - HLA-G CAR-T cells

DRUG

Fludarabine phosphate

DRUG

Cyclophosphamide

DRUG

leukapheresis

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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