^
Contact us  to learn more about
our Premium Content:  News alerts, weekly reports and conference planners
DRUG:

ONCT-808

i
Other names: ONCT-808, ROR1 CAR T-cell therapy, ONCT 808, ONCT808
Company:
Oncternal Therap
Drug class:
ROR1-targeted CAR-T immunotherapy
3ms
ONCT-808-101: A Clinical Study of ONCT-808 in Subjects with Relapsed or Refractory B-Cell Malignancies (clinicaltrials.gov)
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.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
|
CCND1 (Cyclin D1)
|
CCND1 overexpression
|
cyclophosphamide • ONCT-808
1year
Trial-in-Progress: A Phase 1/2 Multi-Center Study of Onct-808, a ROR1-Specific CAR T, in Adult Patients with Relapsed/Refractory Aggressive B Cell Lymphoma (ASH 2023)
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
Clinical • P1/2 data • IO biomarker
|
ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
|
ROR1 expression • ROR1 positive
|
cyclophosphamide • fludarabine IV • zilovertamab vedotin (MK-2140) • ONCT-808
1year
ONCT-808 ROR1 CAR T cells induce significant cancer cell death in mantle cell lymphoma cell line-derived CDX models and in vitro killing assays (SITC 2023)
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.
Preclinical • CAR T-Cell Therapy • IO biomarker
|
IFNG (Interferon, gamma) • ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1) • TNFA (Tumor Necrosis Factor-Alpha)
|
ROR1 expression • ROR1 positive
|
zilovertamab (UC-961) • ONCT-808
over1year
A Clinical Study of ONCT-808 in Subjects With Relapsed or Refractory B-Cell Malignancies (clinicaltrials.gov)
P1/2, N=57, Recruiting, Oncternal Therapeutics, Inc | Not yet recruiting --> Recruiting | Initiation date: Feb 2023 --> May 2023
Enrollment open • Trial initiation date
|
CCND1 (Cyclin D1) • ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
|
CCND1 overexpression • ROR1 positive
|
cyclophosphamide • ONCT-808
5years
Preclinical evaluation of anti-ROR1 CAR T cells employing a ROR1 binding SCFV derived from the clinical stage mab cirmtuzumab. (ASCO-SITC 2020)
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.
CAR T-Cell Therapy • IO biomarker
|
ATR (Ataxia telangiectasia and Rad3-related protein)
|
zilovertamab (UC-961) • ONCT-808
5years
Preclinical evaluation of anti-ROR1 CAR T cells employing a ROR1 binding SCFV derived from the clinical stage mab cirmtuzumab. (ASCO-SITC 2020)
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.
CAR T-Cell Therapy • IO biomarker
|
ATR (Ataxia telangiectasia and Rad3-related protein)
|
zilovertamab (UC-961) • ONCT-808