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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
Satisfactory organ functions:
Subjects with active acute myeloid leukemia (AML) with no available curative treatment options using currently available therapies. Specifically:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My organs are functioning well.
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I have AML and there are no curative treatments left for me.
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I am able to get out of my bed or chair and move around.
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I had a bone marrow transplant, no signs of GVHD, and I'm not on immunosuppression.
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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.
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My bilirubin levels are below 2.0mg/dl, or below 3.0mg/dl if I have Gilbert's syndrome.
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My AML has returned after a stem cell transplant.
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I have a donor ready for a stem cell transplant if needed.
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I had a stem cell transplant over 3 months ago and my disease has returned.
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I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
CART123 cells; cyclophosphamide; fludarabine

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,992 Previous Clinical Trials
42,875,348 Total Patients Enrolled

Media Library

CART123 cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03766126 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Treatment Arm
Acute Myelogenous Leukemia Clinical Trial 2023: CART123 cells Highlights & Side Effects. Trial Name: NCT03766126 — Phase 1
CART123 cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03766126 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted approval to CART123 cells, cyclophosphamide, and fludarabine?

"The safety of CART123 cells; cyclophosphamide; fludarabine has been provisionally rated at a 1 by Power due to the fact that this is an early-stage clinical trial and there is limited data available on its efficacy or security."

Answered by AI

What medical conditions are CART123 cells; cyclophosphamide; fludarabine typically prescribed to treat?

"CART123 cells, cyclophosphamide, and fludarabine are all viable treatments for multiple sclerosis, mixed-cell type lymphoma, and acute myelocytic leukemia."

Answered by AI

Are there any available slots for participants in this clinical experiment?

"Unfortunately, this research program is no longer searching for participants. The trial was first published on December 6th 2018 and last updated June 29th 2022. If you are looking for other studies that might be relevant to your needs, there are 1,470 active trials recruiting patients with leukemia or myeloid cells as well as 889 involving CART123; cyclophosphamide; fludarabine combinations currently open."

Answered by AI

What is the participant capacity of this clinical study?

"The recruitment phase for this medical trial is now closed. It was initially published on December 6th 2018 and its last update was on June 29th 2022. If you are still looking, there currently 1470 trials searching for participants with leukemia or myeloid conditions; 889 studies seeking individuals to receive CART123 cells, cyclophosphamide and fludarabine treatments also exist."

Answered by AI

Have there been any other experiments focusing on the combination of CART123 cells, cyclophosphamide, and fludarabine?

"Presently, 889 clinical trials exploring the use of CART123 cells; cyclophosphamide; fludarabine are in progress. Of these studies, 161 hold a Phase 3 status and 28443 locations host them - with many based out of Philadelphia, Pennsylvania."

Answered by AI
~1 spots leftby Aug 2024