A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Me… (NCT06063317) | Clinical Trial Compass
TerminatedPhase 1
A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)
Stopped: Portfolio prioritization
United States25 participantsStarted 2023-10-02
Plain-language summary
This is an open-label, dose escalation and dose expansion, multi-center phase I study evaluating the safety and tolerability of CF33-CD19 administered intravenously (IV) or intratumorally (IT) in combination with blinatumomab and with or without hydroxyurea in adults with advanced or metastatic solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent from subject or legally authorized representative.
✓. Age ≥ 18 years old on the date of consent.
✓. Life expectancy of at least 3 months.
✓. Any histologically or cytologically confirmed advanced or metastatic solid tumor with documented radiological progression per RECIST v1.1. Eligible subjects must have received at least two prior lines of approved therapies, including targeted therapies, for which they are eligible and failed or relapsed on or after that treatment.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
✓. At least one measurable lesion as defined by RECIST v1.1 criteria.
✓. Adequate renal function.
✓. Adequate hepatic function.
Exclusion criteria
✕. Prior treatment with a poxvirus based oncolytic virus or a bispecific CD19-directed CD3 T-cell engager.
✕. Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
✕. Any radiation within 2 weeks of start of study treatment.
✕. Active autoimmune disease.
What they're measuring
1
All Treatment Arms - Incidence and severity of Adverse Events
Timeframe: From first dose of study drug through 30 days following the last dose of study treatment
2
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
Timeframe: From first dose of study drug through treatment discontinuation, an average of 6 months
3
Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by immune response as seen in cytokines
Timeframe: From first dose of study drug through treatment discontinuation, an average of 6 months
4
Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by anti-tumor activity
Timeframe: From first dose of study drug through treatment discontinuation, an average of 6 months
. Current or history of severe skin disease with open wounds.
✕. History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
✕. History of pancreatitis.
✕. Prior allogeneic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state.