BridgeMD
New treatment option for Relapsed Adult AML
Official title Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT
ClinicalTrials.gov ID: NCT07591649
What this study is testing
What is AdaptNK?
AdaptNK is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for relapsed adult aml.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-institutional Phase I/II study of an allogeneic KIR-HLA mismatched NK cell infusion (AdaptNK) and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy [cyclophosphamide (CY)/fludarabine (FLU)] in patients with relapsed or refractory acute myelogenous leukemia (AML). AdaptNK is a natural killer (NK) cell product that is enriched for NK cells with an "adaptive", or human cytomegalovirus (CMV)-induced, phenotype.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18-74 years with Karnofsky score ≥ 70%
- 75 years and older: KPS ≥ 70%, HCT-CI \< 5 (excluding history of solid tumor), AND not frail by Fried frailty criteria (see Appendix III)
- HLA type C1/C1 or C2/C2 Note: For easy determination, the definition of HLA-C ligand group assigments is included below: HLA-C1 group alleles are...
- adequate liver, renal, pulmonary and cardiac function
- ability to be off glucocorticoids and other immunosuppressive medications indicated for acute or chronic GVHD for at least 28 days prior to the...
You likely can't join if
- Myeloid neoplasms with known or strongly suspected germline background, except DDX41, TP53, or RUNX1.
- Acute promyelocytic leukemia (APL)
- myocardial infarction (MI) within previous 6 months of study enrollment
- pregnant or breastfeeding
- Active CNS involvement with AML
- new or progressive pulmonary infiltrates
See the full eligibility criteria
- 18-74 years with Karnofsky score ≥ 70%
- 75 years and older: KPS ≥ 70%, HCT-CI \< 5 (excluding history of solid tumor), AND not frail by Fried frailty criteria (see Appendix III)
- HLA type C1/C1 or C2/C2 Note: For easy determination, the definition of HLA-C ligand group assigments is included below: HLA-C1 group alleles are defined as HLA-C01, C03, C07, C08, C12, C14, C16 HLA-C2 group alleles are...
- adequate liver, renal, pulmonary and cardiac function
- ability to be off glucocorticoids and other immunosuppressive medications indicated for acute or chronic GVHD for at least 28 days prior to the AdaptNK cell infusion
- There must be sufficient time between the most recent therapy and the screening bone marrow as delineated below:
- anti-leukemic systemic cytotoxic chemotherapy - 2 weeks
- Targeted anti-leukemic agents (FLT-3, IDH, menin inhibitors) - 3 half-lives of the medication
- Radiotherapy - 1 week
- donor lymphocyte infusions - 6 weeks
- hematopoietic growth factors (filgrastim, TPO agonists, EPO) - 1 week
- biologic therapy (monoclonal antibodies, T-cell engagers) - 2 weeks
- Immune effector cellular therapy - 4 weeks
- Intrathecal chemotherapy for treatment of active CNS leukemia - there must be at least two CSF samples negative for leukemia separated by one week before enrollment.
- WBC shall be \< 25,000 before infusion. Hydroxyurea is permitted until day -3 to control excess blast proliferation. No other systemic treatment is allowed after the screening bone marrow is performed for inclusion in...
- All prior treatment related toxicities should have resolved to ≤ grade 1 prior to study enrollment
- agrees to use of adequate contraception from study enrollment to 4 months after cell infusion
- voluntary written consent
- Myeloid neoplasms with known or strongly suspected germline background, except DDX41, TP53, or RUNX1.
- Acute promyelocytic leukemia (APL)
- myocardial infarction (MI) within previous 6 months of study enrollment
- pregnant or breastfeeding
- Active CNS involvement with AML
- new or progressive pulmonary infiltrates
- active autoimmune disease requiring immunosuppressive therapy
- Preexisting inflammatory disease requiring immunosuppressive therapy
- history of severe asthma and currently on chronic systemic medications
- HIV-1/2 positivity or hepatitis C/B
- active systemic infections requiring anti-infective treatment
- received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine)
- Patients with second malignancies are excluded if they have required systemic cytotoxic chemotherapy within 1 year or if they are not in remission
- Exception: patients that are on stable dosing of hormonal therapy (e.g. aromatase inhibitor or antiandrogen therapy) for active breast or prostate cancer for 1 year are eligible.
- Patients with excised basal cell or squamous cell carcinoma of the skin are eligible.
- Patients with excised carcinoma in situ of the cervix or breast are eligible.
- Patients with untreated T1a or T1b prostate cancer are eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.