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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678338
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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
Actual Primary Completion Date : November 2018
Actual Study Completion Date : February 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
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

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


Locations
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United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
St. James University Hospital
Leeds, United Kingdom
The Royal Liverpool University Hospital
Liverpool, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Gilead Sciences
California Institute for Regenerative Medicine (CIRM)
Investigators
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Principal Investigator: Paresh Vyas, FRCP FRCPath University of Oxford
Study Director: Mark Chao, MD PhD Gilead Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02678338    
Other Study ID Numbers: SCI-CD47-002
2015-000720-29 ( EudraCT Number )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Hematologic Neoplasms
Myelodysplastic Syndromes
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Site
Hu5F9-G4
Antineoplastic Agents, Immunological
Antineoplastic Agents