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CAR T-cell Therapy
CAR T-cell Therapy for Acute Lymphoblastic Leukemia (ACIT001/EXC002 Trial)
Phase 1 & 2
Recruiting
Led By Dr. Michael P Chu, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Age of 2 to 70 years at time of screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
ACIT001/EXC002 Trial Summary
This trial is testing a new way to treat cancer using the patient's own immune cells.
Who is the study for?
This trial is for people aged 2-70 with CD19+ non-Hodgkin's lymphoma or ALL who've had at least two prior treatments and aren't eligible for curative therapies. They must have a measurable lesion, adequate organ function, and agree to use effective contraception. Exclusions include unresolved toxicities from past treatments, uncontrolled illnesses, recent major surgery, certain infections like HIV or hepatitis B/C, recent vaccinations, pregnancy/breastfeeding, some prior immunotherapies or gene therapies.Check my eligibility
What is being tested?
The trial tests autologous CAR T-cells targeting CD19 on cancer cells in patients with aggressive lymphoma or ALL. These T-cells are modified outside the body using a lentiviral vector to recognize and attack cancer cells before being reintroduced into the patient.See study design
What are the potential side effects?
Potential side effects may include immune system reactions leading to symptoms such as fever and fatigue (cytokine release syndrome), neurological events like confusion or seizures (neurotoxicity), allergic reactions during infusion of the CAR T-cells, blood cell count changes increasing infection risk, and potential damage to organs.
ACIT001/EXC002 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a measurable tumor or signs of cancer in my blood or bone marrow.
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I am between 2 and 70 years old.
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My cancer is a type of lymphoma or ALL that tests positive for CD19.
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I agree not to donate sperm for up to 2 years after receiving CAR T-cell therapy.
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I have had at least 2 treatments and cannot have surgery or other cures.
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I am mostly active and can care for myself.
ACIT001/EXC002 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area-Under-the-Concentration-vs-time curve (AUC) in peripheral blood and/or bone marrow.
Maximum concentration (Cmax).
Number and type of treatment-related adverse events.
+3 moreACIT001/EXC002 Trial Design
1Treatment groups
Experimental Treatment
Group I: CAR T cellsExperimental Treatment1 Intervention
Patients with relapsed/refractory B-cell ALL or NHL.
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
67,390 Total Patients Enrolled
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,071 Total Patients Enrolled
Alberta Cancer FoundationOTHER
17 Previous Clinical Trials
5,570 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who can father a child and agree to use birth control during and for 3 months after the study.I have a measurable tumor or signs of cancer in my blood or bone marrow.I haven't taken high doses of steroids (more than 20 mg/day of prednisone or equivalent) in the last 7 days.I am between 2 and 70 years old.My cancer has spread to my brain or spinal cord.I have HIV, hepatitis B, or hepatitis C that needs treatment.I agree to use effective birth control or remain abstinent during and 90 days after treatment.My cancer is a type of lymphoma or ALL that tests positive for CD19.My kidney and liver are functioning well enough for the study.I agree not to donate sperm for up to 2 years after receiving CAR T-cell therapy.I have had at least 2 treatments and cannot have surgery or other cures.I had chemotherapy to reduce my tumor size within a week before giving blood for CAR T-cell therapy.I am committed to following the study's procedures for its entire duration.I have not had major surgery in the last 30 days.I don't have ongoing severe side effects from cancer treatment, except for hair loss.I have not had immunotherapy targeting T-cells, CD19 therapies (except blinatumomab), or gene therapy.I have not had any vaccines in the last 4 weeks.I am mostly active and can care for myself.I do not have any severe illnesses that could interfere with the study.I have signed a consent form (or my guardian has if I'm 17 or under).I received a donor lymphocyte infusion less than 4 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: CAR T cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly patients eligible for this trial?
"This trial is for patients aged 2 to 70. There are 517 other trials available for children under 18 and 1930 clinical trials targeting seniors above the age of 65."
Answered by AI
How many volunteers are participating in this experiment?
"The correct, the information available on clinicaltrials.gov reveals that this trial is actively recruiting patients. This study was first advertised on March 3rd 2021 and was updated July 18th 2022. They are looking for 63 people to participate at 6 different locations."
Answered by AI
Who meets the qualifications to enroll in this clinical trial?
"63 patients will receive this experimental therapy, provided they are between 2-70 years old and have been diagnosed with lymphoma. There are several additional requirements listed below: Patients must be aged 2 to 70 years at time of screening, have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; or Karnofsky > 50%, tumor tissue must be available for correlative laboratory studies, patient cannot be eligible for potentially curative standard-of-care therapy, women of childbearing potential agree to use contraceptive methods that result in a failure rate of < 1% per year during the treatment period etc."
Answered by AI
Are researchers looking for more participants in this clinical trial?
"Yes, the most recent update on clinicaltrials.gov shows that this study is still open for recruitment. The trial was posted on March 3rd, 2021 and updated July 18th, 2022. They are looking for 63 participants total, which will be recruited from 6 different locations."
Answered by AI
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