A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC), GI (ONC), GU (ONC), Gyn/Onc (OB/GYNONC), Head & Neck (ONC), Melanoma (ONC), Sarcoma (ONC), Thoracic (ONC)
Current Status: Not open
Phase: I (Cancer Control)
Principal Investigator: Ganti, Apar
Contact Information:
Michaela Savine
misavine@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06063317?term=%09NCT06063317%20&rank=1#participation-criteria
Summary
Primary Objectives:
Safety Run-In Phase
To evaluate safety and tolerability of IV and IT CF33-CD19 as monotherapy and in combination with blinatumomab
To determine the monotherapy recommended Phase II dose (RP2D) dose to apply to Dose Escalation Combination Phase
Dose Escalation Combination Phase
-To evaluate safety and tolerability of IV and IT CF33-CD19 in combination with blinatumomab with and without hydroxyurea
Both Phases
To evaluate the preliminary anti-tumor activity of IV and IT CF33-CD19 monotherapy using RECIST v1.1 (Eisenhauer et al., 2009) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST; Seymour et al., 2017)
To evaluate the preliminary anti-tumor activity of IV and IT CF33-CD19 combination therapy with blinatumomab with and without hydroxyurea using RECIST v1.1 (Eisenhauer et al., 2009) and iRECIST (Seymour et al., 2017)
Dose Escalation Combination Phase
To determine the RP2D for CF33-CD19 (IV and IT) in combination with blinatumomab with and without hydroxyurea