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DRUG:
CHM 1101
i
Other names: CHM 1101, CLTX-CAR T cell therapy, Chlorotoxin-CD28-CD3z-CD19t-expressing CAR T-cells, Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes, CHM1101, CHM-1101
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P1, N=36, Recruiting, City of Hope Medical Center | Trial completion date: Aug 2026 --> Sep 2025 | Trial primary completion date: Aug 2026 --> Sep 2024
10 months ago
Trial completion date • Trial primary completion date
P1, N=36, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2024 --> Aug 2026 | Trial primary completion date: Jan 2024 --> Aug 2026
10 months ago
Trial completion date • Trial primary completion date
Results Here we report clinical outcomes and correlative observations for four lead-in research participants, all of whom had a histopathological diagnosis of glioblastoma, idh wild type, grade 4, and who had received prior temozolomide as well as radiation and other treatments. Conclusions Phase 1 clinical observations to date confirm the feasibility and safety of CLTX-CAR T cell immunotherapy for patients with GBM. These studies will lead to determination of a maximum tolerated dose/maximum feasible dose.
P1, N=36, Recruiting, City of Hope Medical Center | Trial completion date: Feb 2023 --> Dec 2023 | Trial primary completion date: Feb 2023 --> Dec 2023
almost 2 years ago
Trial completion date • Trial primary completion date
Diffuse distribution of CLTX.Cy5.5 was also seen in fixed xenograft sections of PBT003-4, PBT1206, PBT030-2, PBT051 and PBT138 tumor cells, and not obviously associated with more discrete staining for IL13Rα2 and EGFR. Ongoing experiments are further examining association of CLTX with other putative components of CLTX receptor complexes, and their redistribution during binding by CLTX and CLTX-CAR T cells.
Ongoing studies are evaluating biomarkers of response and resistance, including CAR T cell activation and inflammatory cytokines. This clinical study provides first-in-human evidence for the safety and feasibility of CLTX-CAR T cells as a new class of toxin-based CARs for treatment of GBM.
CLTX-CAR T cells specifically and broadly target GBM through recognition of a receptor complex including membrane-bound matrix metalloprotease 2 (MMP-2)...Time to progression, overall survival, and disease response by Response Assessment in Neuro-Oncology (RANO) criteria, will be evaluated and descriptively compared to historical data . The study is actively enrolling patients.