Actively Recruiting
Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)
Led by University of Alberta · Updated on 2026-02-09
63
Participants Needed
6
Research Sites
352 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
A
Alberta Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Autologous, unselected CD3+ lymphocytes collected from apheresis, transfected with a lentiviral vector containing a 2nd generation chimeric antigen receptor (CAR) consisting of a scFv recognizing CD19 and dual co-stimulatory intracellular signaling domains (4-1BB and CD3ζ).
CONDITIONS
Official Title
Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained; guardian consent for children 17 years or younger
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or Karnofsky score above 50%
- Age between 2 and 70 years at screening
- Histologically or cytologically confirmed CD19-positive non-Hodgkin lymphoma or acute lymphoblastic leukemia (ALL)
- At least one measurable lesion or FDG-avid disease by PET/CT for lymphoma, or quantifiable ALL in blood or bone marrow
- Available tumor tissue for laboratory studies
- At least two prior systemic therapies and not eligible for curative standard treatment
- Adequate kidney function (creatinine clearance over 50 mL/min) and liver function (bilirubin less than 1.5 times normal; AST/ALT less than 3 times normal) unless related to cancer
- Women of childbearing potential must agree to abstinence or effective contraception during treatment and for 90 days after
- Male participants must agree to avoid sperm donation during study and use approved contraception for 90 days after treatment
- Reliable and willing to comply with study procedures and availability for study duration
You will not qualify if you...
- Previous treatment with T-cell targeting immunotherapy (except ATG), CD19 antibody therapies (except blinatumomab), or gene therapy
- Any investigational or anti-cancer drug within 30 days
- Participation in another therapeutic clinical trial
- Use of high-dose corticosteroids (over 20 mg prednisone or equivalent) within 7 days before cell collection
- Donor lymphocyte infusion within 4 weeks before cell collection
- Salvage or debulking chemotherapy within 1 week before cell collection
- Prior involvement of the central nervous system
- Unresolved acute toxicity greater than Grade 1 from prior therapies, except alopecia and nonacute toxicities
- Uncontrolled illness including active infection, severe heart failure, unstable angina, significant arrhythmia, or psychiatric/social issues affecting compliance
- Major surgery within 30 days
- Known HIV infection or active hepatitis B or C infection
- Vaccination against infectious diseases within 4 weeks before treatment
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9
Not Yet Recruiting
2
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N4N2
Not Yet Recruiting
3
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B6A8
Not Yet Recruiting
4
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2
Actively Recruiting
5
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G2B7
Not Yet Recruiting
6
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7
Actively Recruiting
Research Team
Z
Zack Breckenridge
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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