Phase
Condition
Lymphoma
Treatment
autologous CD19-directed chimeric antigen receptor (CAR) T-cells
Clinical Study ID
Ages 2-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have given written informed consent prior to any study-specific procedures; children (defined as 17 years of age or less) require guardian consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; or Karnofsky > 50%.
Age of 2 to 70 years at time of screening.
A histologically or cytologically documented, CD19+ non-hodgkin's lymphoma or ALL.
At least 1 measurable lesion or FDG-avid disease by positron-emissiontomography/computed tomography (PET/CT) for lymphoma patients; quantifiable evidenceof ALL in either peripheral blood or bone marrow aspirate.
Tumor tissue (archival or recent acquisition) must be available for correlativelaboratory studies (such as immunohistochemistry, and others).
At least 2 prior systemic therapies and patient must not be eligible for potentiallycurative standard-of-care therapy.
Adequate renal function (defined as Cockroft-Gault creatinine clearance > 50 mL/min)and hepatic function (total bilirubin < 1.5x ULN; and AST/ALT < 3x ULN) unlessdirectly related to malignant disease being treated for on study as demonstratedeither by PET/CT imaging or by biopsy and histopathologic confirmation.
For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive methods that result in a failure rateof < 1% per year during the treatment period and for at least 90 days after the lastdose of study treatment. A woman is considered to be of childbearing potential ifshe is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuousmonths of amenorrhea with no identified cause other than menopause), and has notundergone surgical sterilization (removal of ovaries and/or uterus). Examples ofcontraceptive methods with a failure rate of < 1% per year include bilateral tuballigation, male sterilization, established proper use of hormonal contraceptives thatinhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterinedevices. The reliability of sexual abstinence should be evaluated in relation to theduration of the clinical trial and the preferred and usual lifestyle of the patient.Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulationmethods) and withdrawal are not acceptable methods of contraception.
Male participants should agree to not donate sperm during study period (i.e. up to 2years following CAR T-cell administration).
Male participants with reproductive potential must agree to use medical approvedcontraceptives during the study and for 90 days following the last dose of studytreatment.
Are reliable and willing to make themselves available for the duration of the study,and are willing to follow study procedures.
Exclusion
Exclusion Criteria:
Prior treatment with immunotherapy directly targeting T-cells (except anti-thymocyteglobulin [ATG]), CD19-directed antibody-based therapies (except blinatumomab), orother gene therapy products.
Received any investigational drug/anti-cancer therapy within 30 days.
Concurrent participation in another therapeutic clinical trial.
Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone orequivalent) within 7 days prior to blood collection for CAR T-cell productmanufacture.
Donor lymphocyte infusion (DLI) within 4 weeks prior to leukapheresis.
Salvage or debulking chemotherapy within 1 week prior to blood collection for CART-cell product manufacture.
Prior central nervous system (CNS) involvement.
Unresolved acute toxicity of National Cancer Institute Common Terminology Criteriafor Adverse Events (NCI CTCAE) v4.03 Grade >1 (or baseline, whichever is greater)from prior anticancer therapy. Alopecia and other nonacute toxicities areacceptable.
An uncontrolled intercurrent illness including but not limited to ongoing or activeinfection (including fever within 48 hours of screening), symptomatic congestiveheart failure (i.e., New York Heart Association [NYHA] Class 3 or 4), unstableangina pectoris, clinically significant and uncontrolled cardiac arrhythmia, orpsychiatric illness/social situations that would limit compliance with studyrequirements.
Major surgical procedure within 30 days.
Known history of human immunodeficiency virus (HIV) or active infection requiringtherapy, or positive tests for hepatitis B surface antigen or hepatitis Cribonucleic acid (RNA).
Any vaccination against infectious diseases (e.g., influenza, varicella) within 4weeks (28 days) of initiation of study treatment.
A woman who is pregnant or breastfeeding.
Study Design
Study Description
Connect with a study center
Alberta Children's Hospital
Calgary, Alberta T3B6A8
CanadaSite Not Available
Foothills Medical Centre
Calgary, Alberta T2N2T9
CanadaSite Not Available
Tom Baker Cancer Centre
Calgary, Alberta T2N4N2
CanadaSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G1Z2
CanadaActive - Recruiting
Stollery Children's Hospital
Edmonton, Alberta T6G2B7
CanadaSite Not Available
University of Alberta Hospital
Edmonton, Alberta T6G2B7
CanadaActive - Recruiting
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