Hi Zior, IMU has many remarkable posters who I follow, you are one of them, thank you.
IMO, the first OASIS patient would be in the later stage of her IT monotherapy treatment arm, for her ovarian cancer.
She was dosed 26 October 2023.
Four months tomorrow.
No safety issues reported to date.
Primary Completion (Estimated) September 2024
spicyspu 15/02/24 A response from Nick Ede this afternoon:
The OASIS trial design is different to MAST. The current monotherapy dosing of CF33-CD19 onCARlytics is starting at a high dose, essentially 1 x E8 PFU per dose (9.54E7 PFU to be accurate). There is no dose escalation planned, although when we soon move to the combination phase of the trial, we will deescalate to 3 x E7 PFU before returning to 9.54E7 once safety at the one dose level down is confirmed. Hence the OASIS trial will deliver results much faster than MAST. We are very excited about 2024 and what it will deliver!.
Outcome Measures
Primary (Current)
All Treatment Arms - Incidence and severity of Adverse Events [Time Frame: From first dose of study drug through 30 days following the last dose of study treatment]Adverse events will be graded according to CTCAE v5.0.
Monotherapy Treatment Arms - Determination of the Recommended Phase 2 Dose (RP2D) to apply to Dose Escalation Combination Phase as supported by immune response as seen in lymphocyte subsets [Time Frame: From first dose of study drug through treatment discontinuation, an average of 6 months]Change in lymphocyte subset expression in tumor tissue and peripheral blood pre and post dose
Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by immune response as seen in cytokines [Time Frame: From first dose of study drug through treatment discontinuation, an average of 6 months]Change in cytokine levels in peripheral blood pre and post dose
Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by anti-tumor activity [Time Frame: From first dose of study drug through treatment discontinuation, an average of 6 months]Stable Disease and Response (PR and CR) based on RECIST v1.1 and iRECIST v1.0.
https://clinicaltrials.gov/study/NCT06063317?tab=table
Regards.
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