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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

Must not have

Ongoing or active infections

Live vaccines within the last 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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

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

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

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

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

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I have been diagnosed with acute myeloid leukemia.

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

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

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

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I am not pregnant.

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

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I am 18 years old or older.

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My condition is at risk of worsening despite current treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any ongoing or active infections.

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I have not received any live vaccines in the past 6 months.

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I am taking more than 10mg of prednisone or an equivalent steroid on the day of my NK cell treatment.

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I currently have an infection that isn't under control.

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I have severe side effects from my cancer treatment drugs.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicity (DLT)

Maximum Tolerated Dose (MTD)

Secondary study objectives

1-year Chronic GVHD Rate

1-year Leukemia-Free Survival (LFS)

1-year Overall Survival (OS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Venetoclax

2019

Completed Phase 3

~2240

Interleukin-2

1994

Completed Phase 3

~840