← Back to Search

CAR T-cell Therapy

CIML NK Cells + Venetoclax for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Maximilian Stahl, 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

No history or current symptoms of cardiac disease or treatment with cardiotoxic agents that would limit compliance with study requirements

No prior allogeneic stem cell transplant, organ transplant, donor lymphocyte infusion, CAR-T cell or NK cell therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial tests a combination of cellular and drug therapies to treat AML.

Who is the study for?

Adults with Acute Myeloid Leukemia (AML) who have had at least one cycle of HMA + venetoclax therapy, are not candidates for stem cell transplant, and have a suitable donor for NK cells. Participants must be in good health otherwise, with proper organ function and no severe allergies or autoimmune diseases.Check my eligibility

What is being tested?

The trial is testing the safety and potential effectiveness of CIML NK cells combined with IL-2 and venetoclax as consolidation therapy in AML patients. It includes lymphodepleting therapy before infusing the NK cells to see if this can help treat AML more effectively.See study design

What are the potential side effects?

Possible side effects include reactions from the infusion of NK cells, effects on organ functions due to IL-2 or venetoclax such as liver issues or kidney problems, fatigue, nausea, risk of infection due to immune system suppression by chemotherapy drugs like fludarabine and cyclophosphamide.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have no heart disease history or symptoms, nor have I taken heart-damaging drugs.

Select...

I have not had any organ transplants or specific cell therapies.

Select...

I don't have lasting side effects from previous treatments.

Select...

I don't have autoimmune diseases, am not on steroids, and don't have active hepatitis B or C.

Select...

I have not had cancer before, except for certain types that are now cured.

Select...

I have never had severe anemia caused by red blood cell destruction.

Select...

I have been diagnosed with acute myeloid leukemia.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I have a family donor who matches me and can donate without special preparation.

Select...

My liver, kidneys, heart, and lungs meet the required health standards.

Select...

I am not pregnant.

Select...

I am currently on a treatment combining HMA and venetoclax, and have completed at least one cycle.

Select...

I am 18 years old or older.

Select...

My condition is at risk of worsening despite current treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Dose Limiting Toxicity (DLT)

Maximum Tolerated Dose (MTD)

Secondary outcome measures

1-year Chronic GVHD Rate

1-year Leukemia-Free Survival (LFS)

1-year Overall Survival (OS)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 1: Dose Level 0Experimental Treatment3 Interventions

A maximum tolerated dose (MTD) will be established, and dosage will start at dose level 0. 5-10 participants at dose level 0 will complete: Baseline visit. Bone marrow biopsies: at screening visit #2, end of treatment, and at discretion of PI. Days -6 through -2: predetermined doses of standard-of-care lymphodepleting chemotherapy. Day 0: Predetermined dose of CIML NK cells 1x daily. Hospitalization for up to 3 to 4 weeks for CIML NK infusion. Days 0 through 12: Predetermined dose of IL-2 1x daily every other day for up to 7 doses. Day 7 through Day 21: Predetermined dose of Venetoclax 1 x daily. If ≤1 dose-limiting toxicities (DLTs) are observed, this dose will be the MTD, and 5 additional participants will be enrolled. Follow-up visits: Days 42, 60, 100 and months 6, 9, and 12.

Group II: Cohort 1: Dose Level -1Experimental Treatment3 Interventions

De-escalation to dose level -1 will be conducted per protocol if DLTs occur in Cohort 1 dose Level 0. Participants will complete: Baseline visit. Bone marrow biopsies: at screening visit #2, end of treatment, and at discretion of PI. Days -6 through -2: predetermined doses of standard-of-care lymphodepleting chemotherapy. Day 0: Predetermined dose of CIML NK cells 1x daily. Hospitalization for up to 3 to 4 weeks for CIML NK infusion. Days 0 through 12: Predetermined dose of IL-2 1x daily every other day for up to 7 doses. Day 7 through Day 21: Predetermined dose of Venetoclax 1 x daily. Follow-up visits: Days 42, 60, 100 and months 6, 9, and 12.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Interleukin-2

1994

Completed Phase 3

~700

Venetoclax

2019

Completed Phase 3

~1990

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Leukemia and Lymphoma SocietyOTHER

82 Previous Clinical Trials

17,121 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,862 Total Patients Enrolled

Maximilian Stahl, MDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

22 Total Patients Enrolled

Frequently Asked Questions

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

Are there any potential hazards associated with Cohort 1: Dose Level 0?

"As this is an early-stage trial with only limited data on efficacy and safety, Cohort 1: Dose Level 0 received a score of 1."

Answered by AI

What is the primary goal of this medical research endeavor?

"The primary outcome of the trial, observed between Day 0 to +28 is determining Maximum Tolerated Dose. Secondary outcomes include 1-year Leukemia-Free Survival (measured with Kaplan Meier method), Acute GVHD Rate and 100 day Overall Survival rate."

Answered by AI

Are there currently any openings for volunteers in this experiment?

"clinicaltrials.gov reports that this medical investigation is no longer actively recruiting patients. Initially posted on January 1st 2024 and last updated November 22nd 2023, it has been superseded by 1556 other trials currently open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CIML NK Cells With Venetoclax for AML

Maximilian Stahl, MD 2024. "CIML NK Cells With Venetoclax for AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06152809.

All > Leukemia