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CAR T-cell Therapy

CAR T Cell Therapy for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Mark Geyer, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Primary refractory AML: Patients are eligible from disease perspective in the event of failure to achieve a CR, CRh or CRi after one or more of the following regimens:

Age ≥ 16 years: ECOG ≤ 1 or Karnosfsky ≥ 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial studies a new cancer treatment to see how safe it is and what's the best dose to use.

Who is the study for?

This trial is for people with a type of blood cancer called Acute Myeloid Leukemia (AML) that has CD371+ expression. It's open to all ages, but kids must be over 1 year old and weigh at least 10kg. Adults need functioning liver and kidneys, no active graft-versus-host disease post-transplant, and can't have had certain treatments recently. Pregnant women or those who could become pregnant must use contraception.Check my eligibility

What is being tested?

Researchers are testing a new therapy using special immune cells called CD371-YSNVZ-IL18 CAR T cells to treat AML. They want to find the highest dose that's still safe with few or mild side effects by gradually increasing the amount given to participants.See study design

What are the potential side effects?

While specific side effects aren't listed here, CAR T cell therapies often include symptoms like fever, fatigue, headache, difficulty breathing, rapid heartbeat and low blood pressure which may occur shortly after treatment.

Eligibility Criteria

Inclusion Criteria

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

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My AML did not respond to initial treatment attempts.

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I am 16 or older and can care for myself with minimal assistance.

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I have undergone at least two cycles of treatment combining venetoclax with azacitidine, decitabine, or low-dose cytarabine.

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My AML has returned after treatment or a stem cell transplant.

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My AML has relapsed or is not responding to treatment, and I haven't used all FDA-approved options.

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My kidney function is within the required range for the trial.

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My kidney function is normal for my age.

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My heart's pumping ability is normal or above normal.

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I am under 16 and can do most activities.

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My AML did not fully respond to targeted therapy for its specific mutation.

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I cannot tolerate certain treatments for my advanced leukemia.

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My kidney function, measured by creatinine, is within the normal range.

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My oxygen levels are 92% or higher on room air.

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My AML has returned or is not responding to treatment and tests positive for CD371.

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I have been diagnosed with CD371+ acute myeloid leukemia.

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My AML cancer cells show CD371 presence.

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I have undergone at least two intensive chemotherapy treatments.

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I do not have any signs of ongoing graft-versus-host disease.

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I am receiving CD371-specific CAR T cell therapy.

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I am over 1 year old and weigh more than 10kg.

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I have completed at least 6 cycles of azacitidine or 4 cycles of decitabine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of CAR T cells

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Level 2Experimental Treatment1 Intervention

Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Group II: Dose Level 1Experimental Treatment1 Intervention

Participants with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,892 Total Patients Enrolled

Mark Geyer, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

34 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA greenlit Dose Level 1?

"Since this is a Phase 1 trial, and there are limited clinical data to support its safety and efficacy, Dose Level 1 was assigned the lowest score of one."

Answered by AI

Does this medical experiment have any remaining slots for participants?

"Data hosted on the clinicaltrials.gov website suggests that this trial, which was initially uploaded online on August 22nd 2023 and updated just last week (August 29th), is currently looking for potential participants."

Answered by AI

What is the current headcount for participants in this clinical trial?

"Affirmative. Per the data published on clinicaltrials.gov, this clinical trial is accepting applicants at present. The study was initially listed on August 22nd 2023 and updated most recently on August 29th 2023; it is looking to enlist 6 individuals across 7 sites."

Answered by AI

How many research institutions are currently conducting this investigation?

"This medical trial is enrolling patients from 7 different sites, including Memorial Sloan Kettering Monmouth (Limited protocol activities) in Middletown and the Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale. Also included are participants being recruited at theMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia

2023. "A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06017258.