CAMELLIA: Anti-CD47 Antibody Therapy in Relapsed/Refractory Acute Myeloid Leukaemia

Inclusion Criteria:

1. 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
within 3 weeks of registration.

2. Peripheral white blood cell (WBC) count ≤10x109/L within 1 week of registration (Day
‐7 to Day 1). Patients with WBC >10x109/L can be treated with hydroxycarbamide (up to
4 g/day) throughout the trial to reduce the WBC to ≤10x109/L prior to each dose of
Investigational Medical Product (IMP). The white count must also be measured on the
day of the first dose and be ≤10x109/L.

3. Male or female, Age ≥ 18 years.

4. Eastern Cooperative Oncology Group (ECOG) performance score of 0‐1

5. Willing and able to comply with the protocol for the duration of the study, and
scheduled follow‐up visits and examinations.

6. Willing to undergo blood transfusions as deemed clinically necessary.

7. Pre‐treatment blood cross match completed (as detailed in section 8.4.1.1)

8. Written (signed and dated) informed consent and be capable of co‐operating with
protocol.

9. Haematological and biochemical indices within the ranges shown below:

- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 3 x Upper
Limit of Normal (ULN)

- Alkaline phosphatase ≤ 2 x ULN

- Bilirubin ≤ 2x ULN except for patients with a known or suspected history of
Gilbert's Syndrome

- Epidermal growth factor receptor (eGFR) >35 mls/min (Cockcroft and Galton
method)

Exclusion Criteria:

1. 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.

2. Any prior exposure to Hu5F9‐G4 or other CD47 targeting agents.

3. Treatment with any other investigational agent within 28 days prior to enrolment.

4. Prior cytotoxic chemotherapy (with the exception of hydroxycarbamide), immunotherapy,
or radiotherapy within 4 weeks prior to Day 1.