Gene Therapy Clinical Trials
CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Hu5F9-G4
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Contact
650-498-4331
Not Recruiting