P1/2, N=9, Terminated, Oncternal Therapeutics, Inc | N=57 --> 9 | Trial completion date: Dec 2037 --> Sep 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2026 --> Sep 2024; Based on the available clinical data and capital requirements for continued development, the Company has decided to terminate this study.
3 months ago
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
Zilovertamab vedotin showed preliminary evidence of efficacy and no evidence of on-target off-tumor toxicity in patients with advanced B cell malignancies (Wang 2022)...Subjects will receive a conditioning regimen of intravenous (IV) cyclophosphamide and fludarabine, followed by ONCT-808 IV infusion...The trial is currently active and patients have been treated in the phase 1 dose escalation. Clinical Trial Identifier: NCT05588440
1 year ago
Clinical • P1/2 data • IO biomarker
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ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
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ROR1 expression • ROR1 positive
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cyclophosphamide • fludarabine IV • zilovertamab vedotin (MK-2140) • ONCT-808
Oncternal’s ONCT-808 autologous CAR T cells are genetically modified via ex vivo transduction with a self-inactivating lentivirus vector to express a ROR1-directed CAR containing single chain variable fragment derived from Oncternal’s clinical stage anti-ROR1 zilovertamab. In cancer therapy efficacy studies using CDX models, treatment with ONCT-808 cells resulted in complete tumor remission in ROR1 Jeko-1 cell-derived CDX mice, and controlled tumor growth in Raji cell-derived CDX mice, reflecting the specificity of the ONCT-808 cells to the ROR1 target. Conclusions ONCT-808 demonstrated high efficacy in inducing ROR1 specific cancer cell death in both in vivo and in vitro studies, suggesting its potential in treating human cancer patients.
The generated CAR-T cells utilizing constructs with the Fv of cirmtuzumab, a humanized mAb highly specific for ROR1, onco-embryonic surface antigen, effectively and selectively killed neoplastic cells bearing ROR1 both in vitro and in vivo. As ROR1 expression and signaling has been associated with cancer stemness and chemo-resistance utilizing ROR1 CAR-T therapy to target cancer cells might mitigate tumor escape. These data strongly support the rationale for continued development of our ROR1 CAR-T.
5 years ago
CAR T-Cell Therapy • IO biomarker
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ATR (Ataxia telangiectasia and Rad3-related protein)
The generated CAR-T cells utilizing constructs with the Fv of cirmtuzumab, a humanized mAb highly specific for ROR1, onco-embryonic surface antigen, effectively and selectively killed neoplastic cells bearing ROR1 both in vitro and in vivo. As ROR1 expression and signaling has been associated with cancer stemness and chemo-resistance utilizing ROR1 CAR-T therapy to target cancer cells might mitigate tumor escape. These data strongly support the rationale for continued development of our ROR1 CAR-T.
5 years ago
CAR T-Cell Therapy • IO biomarker
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ATR (Ataxia telangiectasia and Rad3-related protein)