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CAR T-cell Therapy

CD123 Redirected T Cells for 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
AML in second or greater relapse, post-transplant relapse, or chemotherapy-refractory disease. Specifically: Second or greater relapse defined as flow cytometric confirmation of myeloid leukemia of at least 0.1% after second documented complete remission; OR Any detectable disease post-allogeneic transplant with flow cytometric confirmation (MRD) of myeloid leukemia of at least 0.1%; OR Refractory disease, defined as persistent bone marrow involvement with >5% blasts after two courses of induction chemotherapy for patients at initial presentation or >5% bone marrow blasts after one course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR.
Male and female patients ≥ 1 and ≤ 29 years of age at time of consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study Summary

This trial is looking at the safety and effectiveness of a new treatment for leukemia in children. The treatment involves genetically modified cells that are given intravenously.

Who is the study for?
This trial is for children and young adults aged 1 to 29 with Acute Myeloid Leukemia (AML) that has come back after treatment or hasn't responded to chemotherapy. They must have a stem cell donor ready, good heart and lung function, no serious infections like HIV, and not be pregnant.Check my eligibility
What is being tested?
The study tests CART123 cells combined with cyclophosphamide and fludarabine in patients. It's an early-phase trial assessing the safety of this gene therapy where T cells are modified to target leukemia cells in those who've had AML return or resist other treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to immune response such as fever, fatigue, drop in blood pressure; organ inflammation; risk of infection due to weakened immune system; allergic reactions to infusion components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My AML has returned after treatment or is not responding to chemotherapy.
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I am between 1 and 29 years old.
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My leukemia didn't respond to initial or re-induction chemotherapy.
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I can safely undergo leukapheresis.
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My AML has relapsed twice or more, after a transplant, or hasn't responded to chemotherapy.
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I have a donor ready for a stem cell transplant if needed.
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I have a trace of leukemia in my blood after a bone marrow transplant.
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I can do most activities but may need help.
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I am between 1 and 29 years old.
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I can undergo leukapheresis unless I already have the apheresis product.

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
Manufacturing feasibility
Leukemia, Myelocytic, Acute
Secondary outcome measures
Duration of response (DOR)
Leukemia, Myelocytic, Acute
Efficacy of CART123 cells in AML subjects evaluated by reduction of blast count in the peripheral blood and marrow using standard clinical criteria and flow cytometry
+3 more
Other outcome measures
Determine persistence and trafficking of CART123 cells

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
2,000 Previous Clinical Trials
42,880,076 Total Patients Enrolled

Media Library

CART123 cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04678336 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Treatment Arm
Acute Myeloid Leukemia Clinical Trial 2023: CART123 cells Highlights & Side Effects. Trial Name: NCT04678336 — Phase 1
CART123 cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04678336 — Phase 1

Frequently Asked Questions

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

What is the approximate size of this clinical trial's cohort?

"Affirmative. According to the information on clinicaltrials.gov, this investigation is currently enrolling participants and was initially announced on February 15th 2021. As of now, 12 individuals are needed from one medical facility for this trial with a last update occurring at the end of February 2022."

Answered by AI

To what extent are CART123 cells; cyclophosphamide; fludarabine safe for patients to use therapeutically?

"CART123 cells; cyclophosphamide; fludarabine is judged to be at a level 1 safety rating, as there exists only scant evidence in regards to its efficacy and safety profiles."

Answered by AI

Is there any precedent of research involving CART123 cells, cyclophosphamide and fludarabine?

"Presently, 889 separate medical trials for CART123 cells; cyclophosphamide; fludarabine are underway. Of these, 161 have reached the third stage of clinical testing. Philadelphia is hosting most of these studies, though there exists 28443 sites that offer this particular treatment option to patients in need."

Answered by AI

Does this trial offer eligibility to individuals over 30 years of age?

"The requirements for participation in this trial stipulates that the participants must be between one year and twenty-nine years old. There are 753 studies available to those under eighteen, with 1835 opportunities listed on clinicaltrials.gov for individuals aged sixty-five or over."

Answered by AI

Who is able to meet the criteria necessary for participation in this experiment?

"This study is accomodating 12 participants suffering with acute myeloid leukaemia in the pediatrics age range of 1 to 29. The criteria for entry are notably stringent, necessitating a suitable stem cell donor that has been cleared by medical staff and pulmonary reserve graded as Grade 1 dyspnea/Grade 3 hypoxia or above; Left Ventricular Shortening Fraction (LVSF) must be 28%+ or Ejection Fraction 45%+, along with an adequate performance status according to Lansky score or Karnofsky rating of 50+. Moreover, candidates may not have any contraindications for leuk"

Answered by AI

What are CART123 cells; cyclophosphamide; fludarabine typically utilized to treat?

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

Answered by AI

What overarching goals does this medical experiment aim to accomplish?

"This lengthy medical trial will span a period of approximately 5 years and the primary outcome is to determine production feasibility. Additionally, secondary objectives include evaluating CART123 cell efficacy in AML patients by measuring their overall response rate (ORR) at 28 +/- days post-treatment, determining duration of response (DOR), and ascertaining changes in blast count through standard clinical criteria such as CBC with differential counts alongside flow cytometry results."

Answered by AI

Are enrollment opportunities open for this clinical research?

"As evidenced by the clinicaltrials.gov page, this experiment is still recruiting participants since its initial post date of February 15th 2021 with a most recent edit on February 28th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CD123 Redirected T Cells for AML in Pediatric Subjects
2021. "CD123 Redirected T Cells for AML in Pediatric Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678336.
~8 spots leftby Jan 2036
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