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CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies

This study is currently recruiting participants.
Verified August 2017 by Forty Seven, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02678338
First Posted: February 9, 2016
Last Update Posted: August 11, 2017
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.
Information provided by (Responsible Party):
Forty Seven, Inc.
  Purpose
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 Intervention Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Drug: Hu5F9-G4 Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Forty Seven, Inc.:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 40
Actual Study Start Date: November 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hu5F9-G4
Dose Escalation: CD47 blocking antibody Hu5F9-G4
Drug: Hu5F9-G4

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02678338


Contacts
Contact: Paresh Vyas, FRCP FRCPath earlyphasehub@oncology.ox.ac.uk

Locations
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.
Investigators
Principal Investigator: Paresh Vyas, FRCP FRCPath University of Oxford
Study Director: Mark Chao, MD PhD Forty Seven, Inc.
  More Information

Responsible Party: Forty Seven, Inc.
ClinicalTrials.gov Identifier: NCT02678338     History of Changes
Other Study ID Numbers: SCI-CD47-002
2015-000720-29 ( EudraCT Number )
First Submitted: January 27, 2016
First Posted: February 9, 2016
Last Update Posted: August 11, 2017
Last Verified: August 2017

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