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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.
Must not have
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.
Prior central nervous system (CNS) involvement.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial involves using a patient's own immune cells, which are modified in a lab to better recognize and attack cancer cells. The target group is patients with certain types of cancers. The modified cells are reintroduced into the patient to help their immune system fight the cancer more effectively. This approach has shown promising results in treating these cancers.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken high doses of steroids (more than 20 mg/day of prednisone or equivalent) in the last 7 days.
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My cancer has spread to my brain or spinal cord.
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I have HIV, hepatitis B, or hepatitis C that needs treatment.
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I have not had major surgery in the last 30 days.
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I have not had immunotherapy targeting T-cells, CD19 therapies (except blinatumomab), or gene therapy.
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I do not have any severe illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CAR T cellsExperimental Treatment1 Intervention
Patients with relapsed/refractory B-cell ALL or NHL.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Lymphoblastic Leukemia (ALL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, which is effective but can also harm healthy cells. Targeted therapy, such as tyrosine kinase inhibitors, specifically targets genetic mutations in cancer cells, reducing damage to normal cells. Immunotherapy, particularly CAR-T cell therapy, involves modifying a patient's T cells to express a chimeric antigen receptor (CAR) that targets CD19 on leukemia cells, enhancing the immune system's ability to recognize and destroy cancer cells. This approach is significant for ALL patients as it offers a personalized treatment option with the potential for long-term remission, especially in relapsed or refractory cases.

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupNETWORK
131 Previous Clinical Trials
69,484 Total Patients Enrolled
University of AlbertaLead Sponsor
937 Previous Clinical Trials
433,761 Total Patients Enrolled
Alberta Cancer FoundationOTHER
17 Previous Clinical Trials
5,556 Total Patients Enrolled

Media Library

autologous CD19-directed chimeric antigen receptor (CAR) T-cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03938987 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: CAR T cells
Non-Hodgkin's Lymphoma Clinical Trial 2023: autologous CD19-directed chimeric antigen receptor (CAR) T-cells Highlights & Side Effects. Trial Name: NCT03938987 — Phase 1 & 2
autologous CD19-directed chimeric antigen receptor (CAR) T-cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03938987 — Phase 1 & 2
~13 spots leftby Dec 2025