CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies

February 19, 2019 updated by: Gilead Sciences

A Phase I Dose Escalation Trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Haematological Malignancies (CAMELLIA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • Leeds, United Kingdom
        • St. James University Hospital
      • Liverpool, United Kingdom
        • The Royal Liverpool University Hospital
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Oxford, United Kingdom
        • Churchill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hu5F9-G4
Dose Escalation: CD47 blocking antibody Hu5F9-G4
Drug: Hu5F9-G4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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).
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Collaborators

California Institute for Regenerative Medicine (CIRM)

Investigators

  • Principal Investigator: Paresh Vyas, FRCP FRCPath, University of Oxford
  • Study Director: Mark Chao, MD PhD, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-CD47-002
  • 2015-000720-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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