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

Neuroinflammation in Central Nervous System Tumors. (PubMed, Cells) - "The inflammatory profiles of IDH-wildtype and IDH-mutant gliomas and of secondary brain metastases are contrasted. Finally, the correlates of functional neuroimaging, liquid biopsies, and resistance mechanisms to conventional therapies are analyzed, including the GIANT and SENIPERA clinical trials, CARv3-TEAM-E bivalent cellular immunotherapy preconditioned with the LDC + R regimen, and the accelerated approval of dordaviprone (Modeyso) in H3 K27M-mutant diffuse midline gliomas."

IO biomarker • Journal • Review • Brain Cancer • CNS Tumor • Diffuse Midline Glioma • Glioblastoma • Glioma • Oncology • Solid Tumor

Rituximab Pre-conditioning in a Phase I study of CARv3-TEAM-E for Recurrent Glioblastoma (GBM): the INCIPIENT Trial (SNO 2026) - No abstract available

P1 data • Brain Cancer • Glioblastoma • Solid Tumor

Longitudinal single cell transcriptomics of cerebrospinal fluid immune populations in CARv3-TEAM-E treated glioblastoma (SNO 2026) - No abstract available

Clinical • Brain Cancer • Glioblastoma • 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

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

Rituximab pre-conditioning in a phase I study of CARv3-TEAM-E for recurrent glioblastoma (GBM): The INCIPIENT trial. (ASCO 2026) - P1 | "Patients with recurrent GBM were treated with intraventricular CARv3-TEAM-E T cells (10E6 cells per infusion) and one of three pre-treatment regimens: no lymphodepletion (N=3), lymphodepleting chemotherapy with cyclophosphamide and fludarabine (LDC) (N=7), or cyclophosphamide, fludarabine, and rituximab (LDC+R) (N=3). Intraventricular CARv3-TEAM-E infusions were well-tolerated after LDC+R pre-conditioning and no DLTs were noted. The addition of Rituximab abrogated anti-therapy antibody formation and prolonged CAR T-cell persistence in 3/3 patients. Survival data reflect continued promise of CARv3-TEAM-E in patients with recurrent glioblastoma."

First-in-human • P1 data • Brain Cancer • Glioblastoma • Solid Tumor • EGFR

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 • First-in-human • Late-breaking abstract • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • 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 primary completion date: Jun 2026 ➔ Sep 2026 | Trial completion date: Jun 2027 ➔ Sep 2027

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

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

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

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

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