Lead Sponsor

Pfizer

Collaborators

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Subjects with CD22-positive ALL with either refractory disease (i.e. disease progression or no response while receiving their most recent prior anti-cancer therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer therapy with subsequent relapse). Subjects enrolled in the Phase 2 portion of the study must be due to receive salvage 2 or later therapy.
•Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.
•Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.

•Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.
•Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.
•Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).

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