CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies
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ClinicalTrials.gov Identifier: NCT02678338 |
Recruitment Status :
Completed
First Posted : February 9, 2016
Last Update Posted : February 21, 2019
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Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia Myelodysplastic Syndrome | Drug: Hu5F9-G4 | Phase 1 |
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
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Drug: Hu5F9-G4 |
- 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).

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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

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
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 |
Principal Investigator: | Paresh Vyas, FRCP FRCPath | University of Oxford | |
Study Director: | Mark Chao, MD PhD | Gilead Sciences |
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 |
Hematologic Neoplasms Myelodysplastic Syndromes Neoplasms Bone Marrow Diseases Hematologic Diseases |
Neoplasms by Site Hu5F9-G4 Antineoplastic Agents, Immunological Antineoplastic Agents |