What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia, including Anti-CD33 CAR T-Cell Therapy, often have significant side effects. These can include cytokine release syndrome (CRS), which can cause fever, low blood pressure, and difficulty breathing. Other potential side effects are neurotoxicity, leading to confusion, seizures, or encephalopathy, and myelosuppression, resulting in low blood cell counts and increased risk of infection, bleeding, and anemia. Additionally, patients may experience fatigue, nausea, and liver function abnormalities. It is crucial to monitor and manage these side effects closely during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML), including hypomethylating agents like azacitidine and decitabine, which are used for patients ineligible for intensive chemotherapy. Additionally, venetoclax in combination with azacitidine or decitabine has been approved for newly diagnosed AML in older adults or those unable to undergo intensive chemotherapy. While the context does not mention specific FDA approvals for CAR T-Cell therapies targeting CD33 in AML, it does highlight ongoing research and trials in this area, such as the Anti-CD33 CAR T-Cell Therapy, which aims to use genetically modified T cells to target the CD33 protein on AML cells.

What other types of research exist?

Promising novel alternatives to Anti-CD33 CAR T-Cell Therapy for AML patients include: 1) Pharmacologic inhibition of histone demethylation, which is being explored for its potential in targeting cancer cells. 2) Use of chimeric antigen receptor (CAR)-expressing T cells targeting GD2, a protein highly expressed on certain cancer cells. 3) Investigational oral compound ONC201, which is under active investigation for its potential in treating cancers with specific genetic mutations. These alternatives are in various stages of research and clinical trials, showing potential for future treatment options.

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CAR T-cell Therapy

CAR T-Cell Therapy for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Karamjeet S Sandhu

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years post study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment where immune cells are modified to better attack leukemia cells. It targets patients whose leukemia has returned or is resistant to other treatments. The modified immune cells are designed to specifically recognize and kill cancer cells.

Who is the study for?

Adults with acute myeloid leukemia (AML) that has returned or is unresponsive to treatment, who have a life expectancy of at least 16 weeks and are in relatively good health as indicated by certain organ function tests. Participants must not be pregnant, agree to use birth control, and have a potential stem cell donor. Those with active autoimmune diseases, other cancers, significant heart issues within the past 6 months, or infections like HIV or hepatitis are excluded.

What is being tested?

The trial is testing anti-CD33 CAR T-cell therapy for AML patients whose cancer has either come back after treatment or hasn't responded at all. The therapy involves modifying immune cells to target cancer cells more effectively. It's in phase I to determine safety and optimal dosing.

What are the potential side effects?

Potential side effects may include reactions related to the infusion of modified T-cells such as fever and chills, fatigue, risk of infection due to immune system suppression from lymphodepletion therapy prior to T-cell infusion, possible autoimmune responses against normal cells bearing CD33 protein.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years post study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years post study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years post study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose-limiting toxicities and full toxicity profile

Participants who achieve measurable residual disease (MRD)

Secondary study objectives

Duration of response

Expansion and persistence of the CAR T cell product

Overall survival

+2 more

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: Treatment (anti-CD33 CAR T-cells)Experimental Treatment2 Interventions

Patients undergo lymphodepletion therapy 3-5 days prior to CAR T cell infusion and receive anti-CD33 CAR T-cells IV on day 0. Patients with persistent CD33+ AML who are \> 28 days past the initial CAR T infusion, have additional product available and did not experience a dose-limiting toxicity, may optionally receive anti-CD33 CAR T-cells IV.

Do I qualify?Apply below to find out

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 Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as cytarabine and daunorubicin, works by killing rapidly dividing cancer cells but can also affect normal cells, leading to significant side effects. Targeted therapies, like gilteritinib, inhibit specific mutations (e.g., FLT3) in cancer cells, offering a more precise approach with potentially fewer side effects. Immunotherapy, including Anti-CD33 CAR T-Cell Therapy, involves modifying a patient's T cells to target and destroy AML cells expressing the CD33 protein. This approach harnesses the body's immune system to fight cancer more effectively and can be particularly beneficial for patients with refractory or relapsed AML. These treatments are crucial as they offer different mechanisms to combat AML, improving the chances of remission and survival for patients.

CD33-specific chimeric antigen receptor T cells exhibit potent preclinical activity against human acute myeloid leukemia.