Study on Adapt NK Cell Therapy for High-Risk Myeloid Diseases as a Bridge to Stem Cell Transplant
Sponsor: Masonic Cancer Center, University of Minnesota
ClinicalTrials ID:NCT07591649
This clinical trial is testing a new treatment using special NK cells, called AdaptNK, to help patients with high-risk myeloid diseases, like acute myelogenous leukemia (AML), prepare for a stem cell transplant. The study aims to see if this approach is safe and effective.
Patient Parameters
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Program Overview
This study is exploring a new treatment for patients with high-risk myeloid diseases, such as relapsed or hard-to-treat acute myelogenous leukemia (AML). The treatment involves using a special type of natural killer (NK) cells, known as AdaptNK, which are enriched to have an 'adaptive' response. These cells are given to patients after they receive chemotherapy to reduce their immune cells. The goal is to see if this treatment can safely help patients prepare for a stem cell transplant.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 to 74 with a good performance status (Karnofsky score of 70% or higher).
- Adults aged 75 and older with a good performance status, low health risk score, and not considered frail.
- Specific genetic markers (HLA type C1/C1 or C2/C2).
- Good liver, kidney, lung, and heart function.
- Able to stop taking steroids and other immune-suppressing drugs for at least 28 days before receiving AdaptNK cells.
- Enough time must have passed since the last cancer treatment, such as:
- 2 weeks after chemotherapy
- 3 half-lives after targeted therapy
- 1 week after radiotherapy
- 6 weeks after donor lymphocyte infusions
- 1 week after growth factors
- 2 weeks after biological therapy
- 4 weeks after immune cell therapy
- No active leukemia in the central nervous system, confirmed by two negative spinal fluid tests.
- White blood cell count must be below 25,000 before infusion.
- All previous treatment side effects should be mild or resolved.
- Agree to use effective birth control during the study and for 4 months after treatment.
- Willing to provide written consent to participate.
Exclusion Criteria
- Certain genetic myeloid diseases, except specific types like DDX41, TP53, or RUNX1.
- Acute promyelocytic leukemia (APL).
- Recent heart attack within the last 6 months.
- Pregnant or breastfeeding women.
- Active leukemia in the central nervous system.
- New or worsening lung issues.
- Active autoimmune diseases needing treatment.
- Severe asthma requiring ongoing medication.
- Positive for HIV or hepatitis B/C.
- Active infections needing treatment.
- Recent use of experimental drugs within 14 days before starting the study.
- Other cancers needing treatment within the last year, unless stable on hormonal therapy for breast or prostate cancer.
- Patients with treated skin cancer or early-stage prostate cancer are eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mark Juckett, MD | 55455 | Minneapolis | Minnesota |
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