CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase I Dose Escalation Trial of the Humanized Anti-CD47 Monoclonal Antibody Hu5F9-G4 in Haematological Malignancies (CAMELLIA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678338
• Other study ID #: SCI-CD47-002
• Secondary ID: 2015-000720-29
• Status: Completed
• Phase: Phase 1
• Start date: November 2015
• Est. completion date: February 2019

Study information

• Verified date: February 2019
• Source: Forty Seven, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Hematologic Neoplasms
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• Hu5F9-G4

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Forty Seven, Inc.	California Institute for Regenerative Medicine (CIRM)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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).	Up to 28 days