A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)

NCT06063317 | Terminated Phase 1 FDA Drug

• 1 other identifier: CF33-CD19-101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Solid Tumor, Adult

Keywords

Immunotherapy; Oncolytic Virus; Bispecific T-Cell Engager; BiTE; Blincyto

Outcome Measures

Primary Outcomes (4)

• All Treatment Arms - Incidence and severity of Adverse Events

  Adverse events will be graded according to CTCAE v5.0.

  From first dose of study drug through 30 days following the last dose of study treatment

• 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

  Change in lymphocyte subset expression in tumor tissue and peripheral blood pre and post dose

  From first dose of study drug through treatment discontinuation, an average of 6 months

• Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by immune response as seen in cytokines

  Change in cytokine levels in peripheral blood pre and post dose

  From first dose of study drug through treatment discontinuation, an average of 6 months

• Monotherapy Treatment Arms - Determination of RP2D to apply to Dose Escalation Combination Phase as supported by anti-tumor activity

  Stable Disease and Response (PR and CR) based on RECIST v1.1 and iRECIST v1.0.

  From first dose of study drug through treatment discontinuation, an average of 6 months

Secondary Outcomes (7)

• Combination Treatment Arms - Determination of the Recommended Phase 2 Dose (RP2D) for CF33-CD19 + blinatumomab + hydroxyurea combination as supported by immune response as seen in lymphocyte subsets

  From first dose of study drug through treatment discontinuation, an average of 6 months

• Combination Treatment Arms - Determination of RP2D for CF33-CD19 + blinatumomab + hydroxyurea combination as supported by immune response as seen in cytokines

  From first dose of study drug through treatment discontinuation, an average of 6 months

• Combination Treatment Arms - Determination of RP2D for CF33-CD19 + blinatumomab + hydroxyurea combination as supported by anti-tumor activity

  From first dose of study drug through treatment discontinuation, an average of 6 months

• All Treatment Arms - Overall Response Rate

  From first dose of study drug through treatment discontinuation, an average of 6 months

• All Treatment Arms - Progression Free Survival

  From first dose of study drug through treatment discontinuation, an average of 6 months

Study Arms (6)

CF33-CD19 IT Administration Monotherapy

EXPERIMENTAL

Biological: CF33-CD19 IT Monotherapy

CF33-CD19 IV Administration Monotherapy

EXPERIMENTAL

Biological: CF33-CD19 IV Monotherapy

CF33-CD19 IT Administration in Combination with Blinatumomab

EXPERIMENTAL

Biological: CF33-CD19 IT Combination; Drug: Blinatumomab

CF33-CD19 IV Administration in Combination with Blinatumomab

EXPERIMENTAL

Biological: CF33-CD19 IV Combination; Drug: Blinatumomab

CF33-CD19 IT Administration in Combination with Blinatumomab and Hydroxyurea

EXPERIMENTAL

Biological: CF33-CD19 IT Combination; Drug: Blinatumomab; Drug: Hydroxyurea

CF33-CD19 IV Administration in Combination with Blinatumomab and Hydroxyurea

EXPERIMENTAL

Biological: CF33-CD19 IV Combination; Drug: Blinatumomab; Drug: Hydroxyurea

Interventions

CF33-CD19 IT Monotherapy BIOLOGICAL

Safety Run-In Phase: CF33-CD19 will be administered intratumorally on Days 1 and 8 of Cycle 1 and Day 1 of each subsequent 21-day cycle.

CF33-CD19 IT Administration Monotherapy

CF33-CD19 IV Combination BIOLOGICAL

Dose Escalation Combination Phase: CF33-CD19 will be administered intravenously on Days 1 and 15 of each 28 day cycle.

CF33-CD19 IV Administration in Combination with Blinatumomab; CF33-CD19 IV Administration in Combination with Blinatumomab and Hydroxyurea

Blinatumomab DRUG

Blinatumomab will be infused via a 7-day continuous infusion from Days 2-9 and Days 16-23 of each 28-day cycle.

CF33-CD19 IT Administration in Combination with Blinatumomab; CF33-CD19 IT Administration in Combination with Blinatumomab and Hydroxyurea; CF33-CD19 IV Administration in Combination with Blinatumomab; CF33-CD19 IV Administration in Combination with Blinatumomab and Hydroxyurea

Hydroxyurea DRUG

Hydroxyurea will be orally administered daily.

CF33-CD19 IT Administration in Combination with Blinatumomab and Hydroxyurea; CF33-CD19 IV Administration in Combination with Blinatumomab and Hydroxyurea

CF33-CD19 IV Monotherapy BIOLOGICAL

Safety Run-In Phase: CF33-CD19 will be administered intravenously on Days 1 and 8 of Cycle 1 and Day 1 of each subsequent 21-day cycle.

CF33-CD19 IV Administration Monotherapy

CF33-CD19 IT Combination BIOLOGICAL

Dose Escalation Combination Phase: CF33-CD19 will be administered intratumorally on Days 1 and 15 of each 28 day cycle.

CF33-CD19 IT Administration in Combination with Blinatumomab; CF33-CD19 IT Administration in Combination with Blinatumomab and Hydroxyurea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate hematologic function.
• Willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• 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.
• 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.
• Medical history of central nervous system (CNS) metastases unless the subject has completed definitive treatment for the CNS lesions with whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) and are neurologically stable, asymptomatic, and off corticosteroids for at least 2 months prior to first dose.
• History of documented congestive heart failure (New York Heart Association \[NYHA\] class II - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias.
• Bleeding diathesis due to underlying medical condition or ongoing anticoagulation medication.
• History or presence of clinically relevant CNS pathology, or any other CNS disability judged by the Investigator to be clinically significant and precluding informed consent or participation in the study.
• Active infection requiring systemic treatment.

Sponsors & Collaborators

• Imugene Limited: lead

Study Sites (8)

City of Hope

Duarte, California, 91010, United States

Location

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northwestern

Chicago, Illinois, 60208, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Imugene Limited (ASX: IMU) is a publicly-listed Australian biotechnology company developing cancer immunotherapies.

MeSH Terms

Conditions

Bites and Stings

Interventions

blinatumomab; Hydroxyurea

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 2, 2023
• Study Start: October 2, 2023
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)