CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02678338
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):
Forty Seven, Inc.

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Drug: Hu5F9-G4 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Haematological Malignancies (CAMELLIA)
Actual Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: Hu5F9-G4
Dose Escalation: CD47 blocking antibody Hu5F9-G4
Drug: Hu5F9-G4

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02678338

Contact: Paresh Vyas, FRCP FRCPath

United Kingdom
University Hospital of Wales Recruiting
Cardiff, United Kingdom
St. James University Hospital Recruiting
Leeds, United Kingdom
The Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Churchill Hospital Recruiting
Oxford, United Kingdom
Sponsors and Collaborators
Forty Seven, Inc.
Principal Investigator: Paresh Vyas, FRCP FRCPath University of Oxford
Study Director: Mark Chao, MD PhD Forty Seven, Inc.

Responsible Party: Forty Seven, Inc. Identifier: NCT02678338     History of Changes
Other Study ID Numbers: SCI-CD47-002
2015-000720-29 ( EudraCT Number )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Hematologic Neoplasms
Leukemia, Myeloid
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs