What side effects are associated with this type of intervention?

CAR-T cell therapy targeting CD19, such as the one being studied in the trial, is associated with several significant side effects. The most common and serious side effects include cytokine release syndrome (CRS), which can cause fever, low blood pressure, and difficulty breathing, and immune effector cell-associated neurotoxicity syndrome (ICANS), which can lead to confusion, seizures, and brain swelling. Other side effects may include cytopenias (low blood cell counts), infections, and organ toxicities. Traditional chemotherapy for ALL can also cause side effects such as nausea, vomiting, hair loss, and increased risk of infections due to bone marrow suppression.

What prior FDA approvals exist?

The FDA has approved several CAR-T cell therapies for the treatment of Acute Lymphoblastic Leukemia (ALL), particularly targeting CD19. Notable approvals include tisagenlecleucel (Kymriah) for pediatric and young adult patients with relapsed or refractory B-cell ALL, and brexucabtagene autoleucel (Tecartus) for adult patients with relapsed or refractory mantle cell lymphoma, which is also relevant for ALL due to its CD19 targeting mechanism. These therapies involve genetically modifying a patient's T cells to express a chimeric antigen receptor (CAR) that specifically targets the CD19 antigen on leukemia cells, enhancing the T cells' ability to recognize and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to CAR-T cell therapy for Acute Lymphoblastic Leukemia (ALL) patients include: 1) Venetoclax combined with low-dose cytarabine, which has shown efficacy in clinical trials for AML and may be applicable to ALL. 2) Gamma-secretase inhibitors targeting NOTCH1 mutations, which are being explored for refractory T cell ALL/LBL. 3) ONC201, an investigational oral compound under active investigation for H3 K27-altered midline gliomas, which may have potential applications in ALL. 4) Bispecific T cell engagers (BiTEs) such as teclistamab, which target multiple antigens and have shown promise in other hematologic malignancies.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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.

0 / 12Eligibility criteria met

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.