A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07011004
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cytokine Induced Memory-Like Natural Killer Cells — BIOLOGICAL
    Subjects will receive subcutaneous recombinant human IL-2 (rh-IL2) every other day x 6 doses beginning on day 0 via subcutaneous injection.
  • Atezolizumb — BIOLOGICAL
    Single dose of Atezolizumab IV over 60 minutes IV.
  • CIML-NK cell therapy — BIOLOGICAL
    CIML-NK cell therapy as an intravenous (IV) infusion

Study Details

The researchers are doing this study is to find the highest dose of cytokine-induced memory-like (CIML) natural killer (NK) cells in combination with the drug atezolizumab that causes few or mild side effects in people with relapsed/refractory acute myelogenous leukemia (AML). The researchers will also look at whether the treatment combination works against participants' cancer.

Key Dates

Start date
May 30, 2025
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cytokine Induced Memory-Like Natural Killer Cells Combined with Atezolizumb
    Pre-conditioning chemotherapy will consist of a standard lymphodepleting regimen including fludarabine 25 mg/m2 IV daily x 5 on days -6 to - 2 and cyclophosphamide 50 mg/kg IV x 2 on days -5 and -4 prior to the infusion of the CIML-NK cells. Standard MSKCC supportive care guidelines for infusion of chemotherapy including cyclophosphamide will be employed. On the day of infusion subjects will receive a single dose of atezolizumab IV over 60 minutes IV. Subjects will receive subcutaneous recombinant human IL-2 (rh-IL2) every other day x 6 doses beginning on day 0 via subcutaneous injection.

Primary Outcome Measure

The maximum tolerated dose (MTD) [ Time Frame: 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Brian Shaffer, MD
646-608-2091
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
Brian Shaffer, MD
646-608-2091
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Brian Shaffer, MD
646-608-2091
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)CommackNew York11725
Brian Shaffer, MD
646-608-2091
Memorial Sloan Kettering West Harrison (Limited Protocol Activities)HarrisonNew York10604
Brian Shaffer, MD
646-608-2091
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Brian Shaffer, MD
[email protected]
646-608-2091
Mark Geyer, MD
646-608-3745
Brian Shaffer, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville CentreNew York11553
Brian Shaffer, MD
646-608-2091

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited protocol activities)· Commack, NYMemorial Sloan Kettering West Harrison (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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