RecruitingPhase 1Phase 2NCT03938987

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)

A Phase 1b/2 Multi-center, De-centralized, Dose Selection Study of Autologous CD19-directed Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)


Sponsor

University of Alberta

Enrollment

63 participants

Start Date

Mar 3, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 2 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy — a type of immune cell treatment — for people with aggressive lymphoma or acute lymphoblastic leukemia (ALL) that has relapsed (come back) or is not responding to standard treatments. The therapy uses genetically modified versions of your own immune cells that are trained to seek out and destroy cancer cells. **You may be eligible if...** - You have relapsed or treatment-resistant aggressive B-cell lymphoma or acute lymphoblastic leukemia (ALL) - You are between 2 and 70 years old (children require guardian consent) - You are in reasonably good physical condition (able to care for yourself) - Your organs (heart, lungs, liver, kidneys) are functioning adequately **You may NOT be eligible if...** - You have active untreated brain involvement by cancer - You have a serious autoimmune disease - You have had prior CAR-T cell therapy - You are pregnant or breastfeeding - You have severe uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALautologous CD19-directed chimeric antigen receptor (CAR) T-cells

Anti-CD19/4-1BB/CD3ζ CAR T-cell: autologous, unselected CD3+ lymphocytes collected from whole blood or 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). All patients will receive lymphodepleting, conditioning chemotherapy in the form of cyclophosphamide (500 mg/m2/day) and fludarabine (30 mg/m2/day) on Days -5, -4, and -3 prior to a CAR T-cell intravenous, single dose administration on Day 0.


Locations(6)

Foothills Medical Centre

Calgary, Alberta, Canada

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Alberta Children's Hospital

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Stollery Children's Hospital

Edmonton, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

View Full Details on ClinicalTrials.gov

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NCT03938987


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