Actively Recruiting
A Phase 1b/2 Study of Autologous CD19-directed CAR T-cells in Patients With Relapsed or Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia
Led by University of Alberta · Updated on 2026-02-09
63
Participants Needed
6
Research Sites
52 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
This research investigates the use of autologous CD19-directed chimeric antigen receptor (CAR) T-cells in patients with relapsed or refractory aggressive lymphoma or acute lymphoblastic leukemia (ALL). The study evaluates the safety and dosing of these CAR T-cells, which are engineered immune cells targeting CD19 on cancer cells. The trial is conducted in two phases: Phase 1b for dose finding and Phase 2 for dose expansion, involving patients aged 2 to 70 years who meet specific disease and health criteria. Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine on three days before the CAR T-cell infusion. On day 0, a single intravenous dose of the CAR T-cells is administered. During Phase 1b, three dose levels are tested to find the recommended dose for Phase 2. All patients receive the same conditioning chemotherapy before CAR T-cell treatment to prepare their bodies for this therapy. Throughout the study, patients undergo monitoring for treatment-related side effects, dosing toxicities, and CAR T-cell levels in blood or bone marrow for up to three years. Researchers assess response rates by measuring complete or partial remission of disease. Participants will have various evaluations including imaging, laboratory tests, and clinical assessments to track safety, treatment effects, and overall health during and after the therapy.
CONDITIONS
Brief 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...
- Have given written informed consent; children require guardian consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or Karnofsky > 50%
- Age between 2 and 70 years at screening
- Confirmed CD19-positive non-Hodgkin's lymphoma or acute lymphoblastic leukemia
- At least 1 measurable lesion or PET/CT evidence for lymphoma; quantifiable ALL in blood or bone marrow
- Availability of tumor tissue for laboratory studies
- At least 2 prior systemic therapies and not eligible for curative standard therapy
- Adequate kidney function (creatinine clearance > 50 mL/min) and liver function (bilirubin < 1.5x ULN; AST/ALT < 3x ULN) unless related to the cancer
- Women of childbearing potential must agree to abstain or use effective contraception during treatment and for 90 days after
- Male participants must agree not to donate sperm during the study and use approved contraception during treatment and for 90 days after
- Willing to comply with study procedures and available for study duration
You will not qualify if you...
- Prior immunotherapy targeting T-cells, CD19 antibodies (except blinatumomab), or gene therapy
- Investigational drug or anti-cancer therapy within 30 days
- Participation in another therapeutic clinical trial
- High-dose corticosteroids (> 20 mg/day prednisone equivalent) within 7 days before blood collection
- Donor lymphocyte infusion within 4 weeks before leukapheresis
- Salvage or debulking chemotherapy within 1 week before blood collection
- Prior central nervous system involvement
- Unresolved acute toxicity greater than Grade 1 from prior therapy
- Uncontrolled illness including active infection, severe heart failure, unstable angina, significant arrhythmia, or psychiatric/social issues
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days prior to CAR T-cell administration.
3 visits (in-person)
Duration - Single day
Participants receive a single intravenous dose of autologous CD19-directed CAR T-cells on Day 0.
1 visit (in-person)
Duration - Up to 3 years
Participants are monitored for safety and response for up to 3 years following treatment.
Regular visits scheduled throughout follow-up period
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
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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