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CAR T-cell Therapy

Genetically Modified T Cells for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Subjects with active acute myeloid leukemia (AML) with no available curative treatment options using currently available therapies. Specifically:

- ECOG Performance status 0-2

Must not have

HIV infection

Patients with relapsed AML with t(15:17)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment involving genetically modified T cells. The goal is to see if it is safe and effective against AML.

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia (AML) who haven't achieved remission or have relapsed, including after stem cell transplants. They must be over 18, have good organ function and performance status, not pregnant or breastfeeding, without severe active infections like HIV or hepatitis B/C, no history of certain heart conditions or other specific diseases.

What is being tested?

The study tests a new therapy where patients' T cells are modified to target AML cells and then put back into the body. It's combined with two chemotherapy drugs: cyclophosphamide and fludarabine. The goal is to see if this approach is safe and effective against AML.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fever and fatigue, complications from chemotherapy like nausea and low blood counts leading to infection risk, plus possible allergic reactions to the treatment components.

Eligibility Criteria

Inclusion Criteria

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

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I have AML and there are no curative treatments left for me.

Select...

I am able to get out of my bed or chair and move around.

Select...

I have no medical reasons preventing me from undergoing leukapheresis.

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My AML is not in complete remission and may be partially responsive or unresponsive to treatment.

Select...

I have a donor ready for a stem cell transplant if needed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am HIV positive.

Select...

My AML has returned and has a specific genetic feature (t(15:17)).

Select...

I have severe heart condition limitations.

Select...

I have a history of optic neuritis or an immune-related brain disease not caused by leukemia or its treatment.

Select...

My tests show I have the JAK2 V617F mutation.

Select...

I have an active hepatitis B or C infection.

Select...

I am allergic to some ingredients in the study medication.

Select...

I have a history of blood cell disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Evaluate the percentage of manufacturing products that do not meet release criteria for vector transduction efficiency, T cell product purity, viability, sterility.

Safety profile of CART123 cells by monitoring the frequency and severity of adverse events assessed by the National Cancer Institute (NCI) - Common Toxicity Criteria (v5.0)

Secondary study objectives

Duration of response (DOR)

Estimation of CART123 efficacy by evaluation of OS and PFS of subjects at protocol defined intervals which receive at least one infusion of CART123 cells

Necessity of rescue bone marrow transplant

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