P1, N=9, Terminated, Rubius Therapeutics | RTX-321 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared from circulation rapidly (w/in 10 min).

over 1 year ago

Trial completion date • Trial termination • Trial primary completion date • Metastases

CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)

HLA-A*02:01 • HLA-A*02

RTX-321

almost2years

RTX-321 Monotherapy in Patients With HPV 16+ Tumors (clinicaltrials.gov)

P1, N=9, Active, not recruiting, Rubius Therapeutics | Recruiting --> Active, not recruiting | N=63 --> 9

almost 2 years ago

Enrollment closed • Enrollment change

CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)

HLA-A*02:01 • HLA-A*02

RTX-321

3years

[VIRTUAL] A phase 1 study of RTX-321, an engineered red blood cell as an artificial antigen-presenting cell expressing HLA-A*02 with the HPV-16 E7 peptide and 4-1BB ligand with membrane-bound IL-12 for the treatment of HPV 16-positive cancers. (ASCO 2021)

Translational studies will investigate the activation and expansion of HPV16 E7 antigen-specific responses as well as broad innate and adaptive responses in multiple peripheral blood samples over the first 3 cycles of therapy as well as in optional paired tumor biopsies . At this time, the study is open and enrolling patients in the first dose escalation cohort (NCT04672980).

3 years ago

P1 data

HLA-A (Major Histocompatibility Complex, Class I, A)

RTX-321

almost4years

[VIRTUAL] In vivo efficacy and pharmacodynamic analysis of RTX-321, an engineered allogeneic artificial antigen presenting red cell therapeutic (AACR-II 2020)

Together, these data confirm that RCT-aAPC can induce activation of antigen-specific CD8 T cells which can translate to tumor regression. Rubius plans to file an Investigational New Drug application for RTX-321 in HPV16+ advanced solid tumors in 2020.

almost 4 years ago

PK/PD data • Preclinical • Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker

CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • IL2RA (Interleukin 2 receptor, alpha)

RTX-321

4years

An Engineered Allogeneic Artificial Antigen Presenting Red Cell Therapeutic, Rtx321, for Hpv16+ Associated Cancers Promotes Antigen-Specific T Cell Activation & Expansion (ASGCT 2020)

These results support the potential of RTX-321 as an effective aAPC. We plan to file an Investigational New Drug application for RTX-321 for the treatment of patients with HPV 16 positive solid tumors by the end of 2020.

4 years ago

PD(L)-1 Biomarker • IO biomarker

CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • IL2RA (Interleukin 2 receptor, alpha) • CD34 (CD34 molecule)

RTX-321