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New treatment option for Relapsed Non Hodgkin Lymphoma
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)
ClinicalTrials.gov ID: NCT03938987
What this study is testing
What is autologous CD19-directed chimeric antigen receptor (CAR) T-cells?
autologous CD19-directed chimeric antigen receptor (CAR) T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed non hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 70
You may be able to join if
- 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-emission tomography/computed tomography (PET/CT) for lymphoma patients; quantifiable...
You likely can't join if
- Prior treatment with immunotherapy directly targeting T-cells (except anti-thymocyte globulin [ATG]), CD19-directed antibody-based therapies (except...
- 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 or equivalent) within 7 days prior to blood collection for CAR T-cell...
- Donor lymphocyte infusion (DLI) within 4 weeks prior to leukapheresis.
- Salvage or debulking chemotherapy within 1 week prior to blood collection for CAR T-cell product manufacture.
See the full eligibility 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-emission tomography/computed tomography (PET/CT) for lymphoma patients; quantifiable evidence of ALL in either peripheral blood or bone marrow aspirate.
- Tumor tissue (archival or recent acquisition) must be available for correlative laboratory studies (such as immunohistochemistry, and others).
- At least 2 prior systemic therapies and patient must not be eligible for potentially curative 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) unless directly related to malignant disease being treated...
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for...
- Male participants should agree to not donate sperm during study period (i.e. up to 2 years following CAR T-cell administration).
- Male participants with reproductive potential must agree to use medical approved contraceptives during the study and for 90 days following the last dose of study treatment.
- Are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.
- Prior treatment with immunotherapy directly targeting T-cells (except anti-thymocyte globulin [ATG]), CD19-directed antibody-based therapies (except blinatumomab), or other 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 or equivalent) within 7 days prior to blood collection for CAR T-cell product manufacture.
- Donor lymphocyte infusion (DLI) within 4 weeks prior to leukapheresis.
- Salvage or debulking chemotherapy within 1 week prior to blood collection for CAR T-cell product manufacture.
- Prior central nervous system (CNS) involvement.
- Unresolved acute toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 Grade \>1 (or baseline, whichever is greater) from prior anticancer therapy. Alopecia and other...
- An uncontrolled intercurrent illness including but not limited to ongoing or active infection (including fever within 48 hours of screening), symptomatic congestive heart failure (i.e., New York Heart Association [NYHA]...
- Major surgical procedure within 30 days.
- Known history of human immunodeficiency virus (HIV) or active infection requiring therapy, or positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA).
- Any vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks (28 days) of initiation of study treatment.
- A woman who is pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.