CARv3-TEAM-E T cells / Massachusetts General Hospital - LARVOL DELTA

Single-cell RNA sequencing of cerebrospinal fluid in CARv3-TEAM-E treated glioblastoma (SNO 2025) - "We further compare expression signatures in the CSF-sampled T cells to those present in the CARv3-TEAM-E infusion products. In summary, our results elucidate the longitudinal dynamics of T cell gene expression programs in the setting of this first-in-human trial of CARv3-TEAM-E T cells in GBM patients."

Brain Cancer • Glioblastoma • Solid Tumor • EGFR

INCIPIENT: CARv3-TEAM-E T Cells in Glioblastoma (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Marcela V. Maus, M.D.,Ph.D. | Trial completion date: Jan 2027 ➔ Jun 2027 | Trial primary completion date: Jan 2026 ➔ Jun 2026

Trial completion date • Trial primary completion date • Brain Cancer • Breast Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor • MGMT

Single-cell RNA sequencing of cerebrospinal fluid in CARv3-TEAM-E treated glioblastoma (WFNOS 2025) - "We further compare expression signatures in the CSF-sampled T cells to those present in the CARv3-TEAM-E infusion products. In summary, our results elucidate the longitudinal dynamics of T cell gene expression programs in the setting of this first-in-human trial of CARv3-TEAM-E T cells in GBM patients."

Brain Cancer • Glioblastoma • Glioma • Solid Tumor • EGFR

Advances in the Optimization of CAR-T-Cell-Based Therapeutic Approaches to Enhance Antitumor Efficacy in Glioblastoma Treatment. (PubMed, Oncol Ther) - "Three recent studies have demonstrated the safety and feasibility of intracranial CAR-T cell administration in patients with glioblastoma (GBM), along with preliminary evidence of rapid but transient objective responses. These findings provide a rationale for further clinical investigation of this approach."

Journal • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Safety and tolerability of intraventricular CARv3-TEAM-E T cells following lymphodepleting chemotherapy in recurrent glioblastoma: INCIPIENT trial. (ASCO 2025) - P1 | " In a phase 1, first-in-human study (INCIPIENT, NCT05660369), patients with recurrent GBM with EGFRvIII mutation and/or EGFR amplification were eligible to receive up to 6 intraventricular doses of 10x106 CAR T cells via Ommaya catheter after lymphodepleting chemotherapy (LDC) with fludarabine and cyclophosphamide. Intraventricular CARv3-TEAM-E infusions were well tolerated, even with multiple doses, and no DLTs were noted. Toxicity was manageable in all patients with supportive care and anakinra was administered to 3 patients. Steroids were not required to manage toxicity."

Clinical • Brain Cancer • CNS Tumor • Febrile Neutropenia • Glioblastoma • Neutropenia • Oncology • Solid Tumor • EGFR

Immunological correlates from phase I study of CARv3-TEAM-E in patients with recurrent glioblastoma (GBM): INCIPIENT trial. (ASCO 2025) - P1 | "A subset of patients were conditioned with lymphodepleting chemotherapy (LDC) consisting of cyclophosphamide and fludarabine. Following initial infusion, intraventricularly delivered CARv3-TEAM-E T cells were detected in the CSF and peripheral blood in patients with recurrent GBM. Reduced persistence was observed with subsequent infusions. This corresponded with the emergence of anti-CARv3-TEAM-E antibodies in treated patients."

Clinical • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • EGFR

INCIPIENT: CARv3-TEAM-E T Cells in Glioblastoma (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Marcela V. Maus, M.D.,Ph.D. | Trial completion date: Jun 2026 ➔ Jan 2027 | Trial primary completion date: Jun 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Brain Cancer • Breast Cancer • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor • MGMT

Feasibility of Manufacturing CARv3-TEAM-E T Cells for Intraventricular Injection in Recurrent Glioblastoma (ASGCT 2025) - P1 | "All intended autologous CARv3-TEAM-E T-cell products were successfully manufactured, yielding multiple doses. The manufacturing process of CAR transduction and expansion was consistent and reliable as reflected by low (two-fold) variability in T-cell expansion and transduction levels. Intraventricular delivery requires validation not just of manufacturing a CAR product but also of optimal cell concentration, freezing media and controlled rate freezing curves, and thawing conditions and diluent to ensure safe and effective delivery."

Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • AVEN • EGFR • IL2

Single cell RNA sequencing of cerebrospinal fluid lymphocytes in CARv3 TEAM E treated glioblastoma patients (AACR 2025) - "Additionally, we compare expression signatures in the CSF-sampled T cells to those present in the CARv3-TEAM-E infusion products. Taken together, our findings offer insight into the longitudinal dynamics of T cell gene expression programs in the setting of this first-in-human trial of CARv3-TEAM-E T cells in GBM patients."

Clinical • Late-breaking abstract • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • EGFR

Infusion of CARv3-TEAM-E T Cells in Glioblastoma. Reply. (PubMed, N Engl J Med) - No abstract available

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Infusion of CARv3-TEAM-E T Cells in Glioblastoma. (PubMed, N Engl J Med) - No abstract available

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Novel CAR T-Cell Therapy Displays Activity in Glioblastoma (OncLive) - P1 | N=21 | INCIPIENT (NCT05660369) | "Additional findings from the study showed that participant 1 experienced rapid tumor regression per MRI on day 1 after infusion of 10 x 106 CAR-positive CARv3-TEAM-E T cells; the radiographic improvement was confirmed on subsequent scans over the next 2 weeks but was ultimately transient....The percentage of CAR-positive T cells that had surface-bound TEAM in the blood of participants 1, 2, and 3 at this time was 2.0%, 0.64%, and 0.0%, respectively. The percentages of CAR-positive T cells that had surface-bound TEAM in the cerebrospinal fluid samples were 70.3%, 17.6%, and 56.2%, respectively."

P1 data • Glioblastoma

Intraventricular CARv3-TEAM-E T Cells in Recurrent Glioblastoma. (PubMed, N Engl J Med) - P1 | "Radiographic tumor regression was dramatic and rapid, occurring within days after receipt of a single intraventricular infusion, but the responses were transient in two of the three participants. (Funded by Gateway for Cancer Research and others; INCIPIENT ClinicalTrials.gov number, NCT05660369.)."

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • EGFR

CARv3-TEAM-E T Cells in Glioblastoma (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Marcela V. Maus, M.D.,Ph.D. | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jan 2024 ➔ Jun 2025

Enrollment open • Trial completion date • Trial primary completion date • Brain Cancer • Breast Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MGMT

CARv3-TEAM-E T Cells in Glioblastoma (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Marcela V. Maus, M.D.,Ph.D.

New P1 trial • Brain Cancer • Breast Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MGMT