IVS-3001 / Invectys - LARVOL DELTA

Safety and efficacy of HLA-G–targeted CAR T cells (IVS-3001) in patients with advanced HLA-G–positive solid tumors: Clinical trial in progress. (J Clin Oncol) - "Study is currently accruing at Dose level 3. Active recruitment and enrollment are ongoing at The University of Texas MD Anderson Cancer Center, Houston, Texas."

Trial status • Solid Tumor

Safety and efficacy of HLA-G–targeted CAR T cells (IVS-3001) in patients with advanced HLA-G–positive solid tumors: Clinical trial in progress. (ASCO 2025) - P1/2 | "Subjects undergo lymphodepletion with fludarabine and cyclophosphamide on days -5 to -3, followed by CAR-T cell infusion on day 0 and a 28-day monitoring period for dose limiting toxicity...Study is currently accruing at Dose level 3. Active recruitment and enrollment are ongoing at The University of Texas MD Anderson Cancer Center, Houston, Texas."

CAR T-Cell Therapy • Clinical • IO biomarker • Metastases • Oncology • Solid Tumor • HLA-G

Safety and efficacy of HLA-G-targeted CAR T cells (IVS-3001) in patients with advanced HLA-G-positive solid tumors: Clinical trial in progress (AACR 2025) - P1/2 | "Subjects undergo lymphodepletion with fludarabine and cyclophosphamide on days -5 to -3, followed by CAR-T cell infusion on day 0 and a 28-day monitoring period for dose limiting toxicity...Study is currently accruing at Dose level 3. Active recruitment and enrollment are ongoing at The University of Texas MD Anderson Cancer Center, Houston, Texas.Not applicable."

CAR T-Cell Therapy • Clinical • IO biomarker • Metastases • Oncology • Solid Tumor • HLA-G

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) - P1/2 | N=117 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jun 2029 ➔ Dec 2029

CAR T-Cell Therapy • Metastases • Trial completion date • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • BRCA • BRCA1 • BRCA2 • HLA-G

FDA Grants Fast Track designation to IVS-3001, a CAR-T Cell Therapy in the Treatment of Renal Cell Carcinoma (GlobeNewswire) - "Invectys, Inc...is pleased to announce the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its revolutionary product, IVS-3001....The Fast Track designation to IVS-3001 was based on the compelling data from the Investigational New Drug Application (IND) submission, and the potential for addressing the unmet need in patients with HLA-G positive locally advanced or metastatic clear cell renal cell carcinoma (RCC) who have failed or are intolerant to standard RCC therapies."

Fast track designation • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Invectys Announces Initiation of Phase 1/2a Clinical Trial in Solid Tumors and Change in Leadership (GlobeNewswire) - "Invectys, Inc...today announces it has initiated the clinical trial of its lead CAR-T program, IVS-3001, in solid tumors...IVS-3001 is Invectys’ cutting-edge CAR-T cell therapy, targeting the rarely exploited immune checkpoint and tumor specific antigen known as HLA-G...A Phase I/2a clinical trial (NCT05672459) was initiated at The University of Texas MD Anderson Cancer Center on June 21, 2023, in HLA-G-positive solid tumor patients, particularly those with kidney and ovarian cancers."

Trial status • Genito-urinary Cancer • Gynecologic Cancers • Kidney Cancer • Oncology • Ovarian Cancer • Solid Tumor

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) - P1/2 | N=117 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2023 ➔ Jun 2023

CAR T-Cell Therapy • Enrollment open • Metastases • Trial initiation date • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • BRCA • BRCA1 • BRCA2 • HLA-G

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) - P1/2 | N=117 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2029 ➔ Jun 2029 | Initiation date: Jun 2023 ➔ Feb 2023

CAR T-Cell Therapy • Metastases • Trial completion date • Trial initiation date • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • BRCA • BRCA1 • BRCA2

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 (clinicaltrials.gov) - P1/2 | N=117 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

CAR T-Cell Therapy • Metastases • New P1/2 trial • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • BRCA • BRCA1 • BRCA2

Updated Invectys and CTMC announce FDA clearance of IND application for anti-HLA-G CAR-T cell therapy (GlobeNewswire) - "Invectys, Inc. and CTMC...announced Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for a Phase 1/2a clinical study of IVS-3001, Invectys’s lead engineered human leukocyte antigen A (HLA-G) targeting chimeric antigen receptor (CAR) T cell therapy for the treatment of solid tumors....The planned first-in-human, single-arm, open-label, Phase 1/2a study will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of IVS-3001 in patients with histologically or pathologically confirmed diagnosis of a locally advanced unresectable or metastatic HLA-G+ select solid tumor malignancy who failed or was intolerant to standard of care therapies known to confer clinical benefit per treating physician."

IND • New P1/2 trial • Oncology • Solid Tumor

Invectys and CTMC announce FDA clearance of IND application for anti-HLA-G CAR-T cell therapy (GlobeNewswire) - "Invectys, Inc. and CTMC...today announced Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for a Phase 1/2a clinical study of IVS-3001...for the treatment of solid tumors....The planned first-in-human, single-arm, open-label, Phase 1/2a study will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of IVS-3001 in patients with histologically or pathologically confirmed diagnosis of a locally advanced unresectable or metastatic HLA-G+ select solid tumor malignancy who failed or was intolerant to standard of care therapies known to confer clinical benefit per treating physician."

IND • New P1/2 trial • Oncology • Solid Tumor