Cytokine-induced memory-like NK cell therapy for relapsed acute myeloid leukemia after transplant
Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant in Children and Adults
This study is testing a new treatment using special immune cells to see if it can help people with relapsed acute myeloid leukemia feel better after a stem cell transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT03068819 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of cytokine-induced memory-like (CIML) natural killer (NK) cells combined with donor lymphocyte infusion (DLI) in patients who have relapsed acute myeloid leukemia (AML) following allogeneic hematopoietic cell transplant. The approach aims to enhance the graft versus leukemia effect, potentially leading to improved remission rates and long-term survival for these patients. The trial includes both pediatric and adult cohorts, focusing on those with a history of relapsed AML and adequate organ function. The study seeks to determine if this combination therapy can provide a more effective treatment option for patients with poor prognoses.
Who should consider this trial
Good fit: Ideal candidates include patients with relapsed AML who have undergone an allogeneic hematopoietic cell transplant and have a willing donor for cell collection.
Not a fit: Patients with active central nervous system involvement from AML or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve remission rates and survival outcomes for patients with relapsed AML after transplant.
How similar studies have performed: Other studies have shown promising results with similar approaches using NK cell therapies, indicating potential for success in this novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
Recipient Inclusion Criteria: * Relapsed AML after HLA-matched related or unrelated allogeneic hematopoietic cell transplant * For pilot pediatric/young adult patient cohort ≥1 and \<18 years of age * For phase 2 adult patient cohort ≥18 years of age * Available original donor (same donor as used for the initial stem cell transplant) that is willing and eligible for non-mobilized collection * Patients with known central nervous system (CNS) involvement with AML are eligible provided that they have been treated and cerebrospinal fluid (CSF) is clear for at least 2 weeks prior to enrollment into the study. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment. * Karnofsky performance status \> 60 % * Adequate organ function as defined below: * Total bilirubin \< 2 mg/dL * AST(SGOT)/ALT(SGPT) \< 3.0 x IULN * Creatinine within normal institutional limits OR creatinine clearance \> 60 mL/min/1.73 m2 by Cockcroft-Gault Formula * Oxygen saturation ≥90% on room air * Not currently requiring systemic corticosteroid therapy (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) or any other immune suppressive medications * Women of childbearing potential must have a negative pregnancy test within 28 days prior to study registration. Female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study including throughout the initial evaluation period (100 days after CIML NK cell infusion). * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Recipient Exclusion Criteria: * Acute or chronic GvHD with ongoing active systemic treatment. * Circulating blast count \>10,000/uL by morphology or flow cytometry (cyto-reductive therapies, including salvage chemotherapy, is encouraged prior to study enrollment) * Uncontrolled bacterial or viral infections, or known HIV, Hepatitis B, or Hepatitis C infection. * Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities. * New or progressive pulmonary infiltrates concerning for new or uncontrolled infectious process. * Known hypersensitivity to one or more of the study agents * Received any investigational drugs within the 14 days prior to CIML NK cell infusion date * Pregnant and/or breastfeeding Donor Inclusion Criteria: * At least 18 years of age * Same donor as used for the allo-HCT * In general good health, and medically able to tolerate leukapheresis * Ability to understand and willingness to sign an IRB approved written informed consent document Donor Exclusion Criteria: * Active hepatitis, positive for HTLV, or HIV on donor viral screen * Pregnant
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Amanda Cashen, M.D. — Washington University School of Medicine
- Study coordinator: Amanda Cashen, M.D.
- Email: acashen@wustl.edu
- Phone: 314-454-8323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.