A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Refractory to at least two attempts at prior induction therapy. An attempt is defined as either a single cycle of combination chemotherapy such as daunorubicin/anthracycline OR a single monthly cycle of a hypomethylating agent with venetoclax.
Patients with FLT3-ITD or -TKD mutations must have received at least one commercially available inhibitor of FLT3.
Patients with NPM1 mutation or rearrangements of MLL must be refractory to revumenib.
Patients with mutations in IDH1 or IDH2 must be refractory to at least one commercially available inhibitor of IDH1 or IDH2, respectively.
Disqualifiers
Prior allogeneic hematopoietic cell transplantation.
Subjects with active/uncontrolled CNS leukemia. Subjects with prior CNS disease must have no detectable evidence of CSF disease for at least 4 weeks prior to enrollment.
Subjects requiring systemic immunosuppression for any indication are excluded.
New York Heart Association Class II or greater congestive heart failure.
Trial design
Design model
Single group
Treatments tested in this trial
Cytokine Induced Memory-Like Natural Killer Cells
Biological/VaccineSubjects will receive subcutaneous recombinant human IL-2 (rh-IL2) every other day x 6 doses beginning on day 0 via subcutaneous injection.
Atezolizumb
Biological/VaccineSingle dose of Atezolizumab IV over 60 minutes IV.
CIML-NK cell therapy
Biological/VaccineCIML-NK cell therapy as an intravenous (IV) infusion
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Cytokine Induced Memory-Like Natural Killer Cells Combined with AtezolizumbExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
The maximum tolerated dose (MTD)
of the combination of CIML-NK cells with atezolizumab in subjects with r/r-AML. The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.
Time frame
2 yearsSecondary outcomes
1
The response rate (CR/CRi)
Disease response assessments will be according to the ELN2022 criteria.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov