Clinical trial NCT02678338: CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies
Official title: A Phase I Dose Escalation Trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Haematological Malignancies (CAMELLIA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: California Institute for Regenerative Medicine (CIRM)
First posted: 2016-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Leeds
country: United Kingdom
facility: St. James University Hospital
city: Liverpool
country: United Kingdom
facility: The Royal Liverpool University Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: University of Oxford
name: Paresh Vyas, FRCP FRCPath
role: PRINCIPAL_INVESTIGATOR
affiliation: Gilead Sciences
name: Mark Chao, MD PhD
role: STUDY_DIRECTOR
References:
citation: Brierley CK, Staves J, Roberts C, Johnson H, Vyas P, Goodnough LT, Murphy MF. The effects of monoclonal anti-CD47 on RBCs, compatibility testing, and transfusion requirements in refractory acute myeloid leukemia. Transfusion. 2019 Jul;59(7):2248-2254. doi: 10.1111/trf.15397. Epub 2019 Jun 10.