CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Children, Adolescents and Young
Adults with Refractory CD22+ Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkin Lymphoma (NHL)
to estimate the maximum tolerated cummulative dose (MTCD), defined as the highest dose and
number of doses that can be safely administered to a participant, and to establish a safe
dose, based on the MTCD, for subsequent clinical testing.

Inclusion Criteria:

- Histologically confirmed diagnosis of acute lymphoblastic leukemia (ALL) or non-Hodgkin's
lymphoma (NHL) including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell
lymphoma; - Measurable or evaluable disease. - Evidence of CD22-positive malignancy by one
of the following criteria: - greater than or equal to (>=) 30 % of malignant cells from a
disease site cluster of differentiation 22+ (CD22+) by fluorescence-activated cell sorter
(FACS) analysis or; ≥ 15 % of malignant cells from a disease site CD22+ by
immunohistochemistry (IHC). Stage of disease: - Participants must have relapsed or
refractory disease and have received at least one standard chemotherapy and one salvage
regimen or allogeneic stem cell transplant; - Relapse after prior autologous or allogeneic
HSCT is allowed. In the event of relapse after prior allogeneic HSCT, the participant must
be at least 100 days post-transplant and have no evidence of ongoing active graft-vs-host
disease; - Recovered from the acute toxic effects of all prior therapy before entry.
Performance status: - Participants greater than or equal to (>=) 12 years of age: Eastern
Cooperative Oncology Group (ECOG) score of 0, 1, 2, or 3; - Participants < 12 years of age:
Lansky scale >= 50%; - Participants who are unable to walk because of paralysis, but who
are up in a wheel chair will be considered ambulatory for the purpose of calculating the
performance score. Participants with the following central nervous system (CNS) status, are
eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as
cranial nerve palsy. - Female and male participants with childbearing potential and their
sexual partners must agree to use an approved method of contraception during the study.

Exclusion Criteria:

- Participants meeting any of the following criteria are not eligible for participation in
the study: - Isolated testicular or CNS ALL; Hepatic function: - Inadequate liver function
defined as total bilirubin > 2 × upper limit of normal (ULN) (except in the case of
participants with documented Gilbert's disease > 5 × ULN) or transaminases (ALT and
aspartate aminotransferase [AST]) > 5 × ULN based on age- and laboratory-specific normal
ranges; Renal function: - With greater than age-adjusted normal serum creatinine (see Table
below) and a creatinine clearance > 60 millilitre per minute mL/min/1.73 m2. - Age(Years)-
Maximum Serum Creatinine (mg/dl)[≤5,0.8] [5 < age less than or equal to 10,1.0] [10 < age
less than or equal to 15,1.2 [> 15, 1.5] Hematologic function: - For non-leukemic subjects
only, absolute neutrophil count (ANC) < 1000/cmm, or platelet count < 50,000/cmm, if these
cytopenias are not judged by the investigator to be due to underlying disease (ie
potentially reversible with anti-neoplastic therapy); - Participants with CNS 3 disease; -
Hyperleukocytosis (≥ 50,000 blasts/µL) or rapidly progressive disease (PD) that in the
estimation of the investigator and sponsor would compromise ability to complete study
therapy; - Prior treatment with CAT-3888 (BL22) or any pseudomonas-exotoxin-containing
compound; - HIV positive serology (due to increased risk of severe infection and unknown
interaction of CAT-8015 with antiretroviral drugs); - Active hepatitis B or C infection.