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CAR T-cell Therapy

CIML NK Cells for Leukemia

Phase 1
Waitlist Available
Led By Rizwan Romee, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function within 2 weeks of NK cell infusion as defined below: Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then <3 x ULN) AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN Serum creatinine ≤2.0mg/dL O2 saturation: ≥90% on room air LVEF >40%. If there is no clinical evidence of a change in cardiovascular function from the time of pre-transplantation ECHO, then there is no need to repeat it. Otherwise, an ECHO will need to be repeated within 2 weeks of NK cell infusion.
No other systemic medications/treatments (e.g. ECP) for GVHD for at least 4 weeks prior to cell infusion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is studying CIML NK cells plus IL-2 in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or myeloproliferative neoplasms who have relapsed after stem cell transplantation.

Who is the study for?
Adults and children (12+) with certain relapsed myeloid diseases after stem cell transplant can join. They need a willing original donor for cell collection, no recent severe GVHD treatments, and must use birth control. Excluded are those with autoimmune disease, active infections like hepatitis or HIV, recent other cancer treatments outside of specific exceptions, or uncontrolled illnesses.Check my eligibility
What is being tested?
The trial is testing CIML NK cells combined with IL-2 in patients who have had a relapse of AML, MDS or MPN after stem cell transplantation. It will evaluate the safety and effectiveness of this treatment approach in both adult and pediatric patients.See study design
What are the potential side effects?
Potential side effects may include reactions to the infusion such as fever or chills, organ inflammation due to immune response from IL-2 therapy, increased risk of infection from Fludarabine/Cyclophosphamide chemotherapy regimen used before NK cell infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't taken any systemic treatments for GVHD in the last 4 weeks.
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I can take care of myself and do some daily activities.
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I haven't taken high-dose steroids or certain immune system drugs for 4 weeks.
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I am not pregnant or capable of becoming pregnant.
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I agree to use birth control during and up to 4 months after the study.
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My bone marrow is less than 80% involved and I may be taking specific medications to control my condition.
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My disease is still present after stem cell transplant and it's been over 2 months.
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My original stem cell donor is available and willing to donate again without mobilization.
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My AML, MDS, or MPN has returned or persisted after a transplant.
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I can understand and am willing to sign the consent form.
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I am 12 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety
Secondary outcome measures
Acute GVHD (Incidence, Severity)
Chronic GVHD (Incidence, Severity)
LFS and OS
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CIML NKExperimental Treatment3 Interventions
CIML NK cells will be administered intravenously on day 0. Fludarabine will be administered as IV infusion once daily for 3 doses beginning on day -5. Cyclophosphamide will be administered as IV infusion on days -5 and -4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1090
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,071 Previous Clinical Trials
340,314 Total Patients Enrolled
The Leukemia and Lymphoma SocietyOTHER
80 Previous Clinical Trials
16,924 Total Patients Enrolled
Rizwan RomeeLead Sponsor

Media Library

CIML NK (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04024761 — Phase 1
Acute Myeloid Leukemia Research Study Groups: CIML NK
Acute Myeloid Leukemia Clinical Trial 2023: CIML NK Highlights & Side Effects. Trial Name: NCT04024761 — Phase 1
CIML NK (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04024761 — 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 scope of patients participating in this clinical trial?

"Affirmative. Per the details published on clinicaltrials.gov, this research project is actively recruiting participants and was last updated on June 15th 2022. 50 individuals shall be sourced from two sites for inclusion in the study; it first opened to applicants back on August 31st 2019."

Answered by AI

What have been the major findings of research concerning CIML NK?

"At present, 889 live studies are being conducted on CIML NK. Out of these research operations, 161 have reached the advanced Phase 3 stage. While a majority of trials occur in Philadelphia, Pennsylvania - 28443 sites around the world are running experiments with this drug treatment."

Answered by AI

What evidence exists to demonstrate the safety of CIML NK for patients?

"There is only a small amount of evidence attesting to the safety and efficacy of CIML NK, thus it received an assessment of 1."

Answered by AI

What symptoms have been addressed most often with CIML NK therapy?

"CIML NK is a popular medication for the treatment of multiple sclerosis, but it may also be efficacious in treating conditions such as mixed-cell type lymphoma, leukemia, myelocytic acute and retinoblastoma."

Answered by AI

Are there any available openings for participants in this research?

"Affirmative. Clinicaltrials.gov suggests that this research study is still searching for participants, which was first made known on August 31st 2019 and has been revised as of June 15th 2022. The trial necessitates 50 people to be enrolled from two separate medical sites."

Answered by AI
~6 spots leftby Dec 2024