CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome
• Interventions: Drug: Hu5F9-G4

• Registration Number: NCT02678338
• Lead Sponsor: Gilead Sciences

Brief Summary

This phase I trial studies the side effects and best dose of anti-cluster of differentiation (CD)47 monoclonal antibody Hu5F9-G4 in treating patients with haematological malignancies including acute myeloid leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory), or high risk myelodysplastic syndrome. Monoclonal antibodies, such as anti-CD47 monoclonal antibody Hu5F9-G4, block cancer growth in different ways by targeting certain cells.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-09
• Primary Completion: 2018-11
• Status Verified: 2019-02
• Study Completion: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) Acute Myeloid Leukemia (AML) (defined by World Health Organization (WHO) criteria) for which no further conventional therapy is suitable for the patient, or confirmed myelodysplastic syndrome defined according to WHO classification, with an International Prognostic Scoring System (IPSS) risk category of intermediate-2 or high risk, that is relapsed, refractory or intolerant to conventional therapy within 3 weeks of registration.
• Male or female, Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
• Willing to undergo blood transfusions as deemed clinically necessary.
• Adequate hematological, liver, and kidney function

Key

Exclusion Criteria

• Females: Pregnant or breast-feeding women, or women of childbearing potential unless effective method of contraception is used during and for 3 months after the trial. Males: unless an effective method of contraception is used during and for 3 months after the trial.
• Any prior exposure to Hu5F9-G4 or other CD47 targeting agents.
• Treatment with any other investigational agent within 28 days prior to enrolment.
• Previous allogeneic stem cell transplant within 6 months prior to enrolment, active graft vs host disease (GVHD), or requiring transplant-related immunosuppression
• Evidence for active CNS involvement by leukaemia
• Clinical evidence or known history of cardiopulmonary disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hu5F9-G4	Hu5F9-G4	Dose Escalation: CD47 blocking antibody Hu5F9-G4

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of Hu5F9-G4, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Part A)	Up to 28 days	MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).

Trial Locations

Locations (5)

St. James University Hospital; 🇬🇧 Leeds, United Kingdom

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom

The Royal Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Churchill Hospital; 🇬🇧 Oxford, United Kingdom