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NCT05115630

Off-the-shelf NK Cells + SCT for Myeloid Malignancies

Completed Phase 2 Results posted Last updated 19 December 2025
What this trial tests

Phase 2 trial testing Cyclophosphamide in Myeloid Malignancies in 24 participants. Completed in 15 May 2025.

Timeline
8 April 2022
Primary endpoint
15 May 2025
15 May 2025

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment24
Start date8 April 2022
Primary completion15 May 2025
Estimated completion15 May 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 18 to 70, any sex, with Myeloid Malignancies or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced Graft Failure Primary · 28 days post-transplant

Primary Graft failure is defined as failure to achieve an ANC \> 0.5 x 109/L for 3 consecutive days by day 28 post SC infusion, with no evidence of donor derived cells by bone marrow chimerism studies and no evidence of persistent or relapsing disease.

GroupValue95% CI
NK Cell Infusion in Combination With Fludarabine Melphalan and TBI for Participants Undergoing SCT0
Number of Participants Experienced Non-relapsed Mortality at 100 Day Post Transplant Secondary · 100 days post-transplant

Number of participants died from any cause other than relapse disease.

GroupValue95% CI
NK Cell Infusion in Combination With Fludarabine Melphalan and TBI for Participants Undergoing SCT4
Number of Participants in Subsequent Transplant Prior to NK Cell Infusions/Stem Cell Transplant Secondary · On the day of study consent

Number participants had prior allogeneic transplants before study enrollment

GroupValue95% CI
NK Cell Infusion in Combination With Fludarabine Melphalan and TBI for Participants Undergoing SCT10

Adverse events — posted to ClinicalTrials.gov

Time frame: 100 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NK Cell Infusion in Combination With Fludarabine Melphalan and TBI for Participants Undergoing SCT
Serious: 5/21 (24%)
Deaths: 12/21

Serious adverse events (15 terms)

ReactionSystemNK Cell Infusion in Combin…
BacterialInfections and infestations
Secondary graft failureBlood and lymphatic system disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
ViralInfections and infestations
ARDSRespiratory, thoracic and mediastinal disorders
DiarrheaGastrointestinal disorders
EncephalopathyNervous system disorders
FungalInfections and infestations
Gastrointestinal bleedingGastrointestinal disorders
Guillain-Barre SyndromeNervous system disorders
HSCT related microangiopathy (TA-TMA)Blood and lymphatic system disorders
Low granulocyteBlood and lymphatic system disorders
Pericardial effusionCardiac disorders
PericarditisCardiac disorders
Platelet count decreasedInvestigations
Other adverse events (43 terms — click to expand)

ReactionSystemNK Cell Infusion in Combin…
NauseaGastrointestinal disorders
Fluid overloadGeneral disorders
BacterialInfections and infestations
DiarrheaGastrointestinal disorders
RashSkin and subcutaneous tissue disorders
Creatinine increasedInvestigations
Hemorrhagic CystitisRenal and urinary disorders
Febrile neutropeniaBlood and lymphatic system disorders
HypertensionVascular disorders
Oral mucositisGastrointestinal disorders
ViralInfections and infestations
ALT increasedInvestigations
HemorrhoidsGastrointestinal disorders
AST increasedInvestigations
HypotensionVascular disorders
HeadacheNervous system disorders
HiccupsRespiratory, thoracic and mediastinal disorders
Thromboembolic eventVascular disorders
ConstipationGastrointestinal disorders
T bilirubin increasedInvestigations
TremorNervous system disorders
Cystitis noninfectiveRenal and urinary disorders
Ejection fraction decreasedCardiac disorders
EncephalopathyNervous system disorders
HypokalemiaMetabolism and nutrition disorders
Pericardial effusionCardiac disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
TachycardiaCardiac disorders
VODHepatobiliary disorders
Respiratory, thoracic and mediastinal disorders
Abdominal painGastrointestinal disorders
Allergic reactionImmune system disorders
AnorexiaMetabolism and nutrition disorders
Bone painMusculoskeletal and connective tissue disorders
Chest painCardiac disorders
DyspepsiaGastrointestinal disorders
FungalInfections and infestations
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
HSCT related microangiopathy (TA-TMA)Blood and lymphatic system disorders
Infusion related reactionInjury, poisoning and procedural complications

Most-reported serious reactions: Bacterial, Secondary graft failure, Pneumonitis, Viral, ARDS, Diarrhea, Encephalopathy, Fungal.

Data from ClinicalTrials.gov NCT05115630 adverse events section.

Sponsor's own description

The goal of this clinical research study is to learn about the safety and effectiveness of giving KDS-1001 in combination with a standard stem cell transplant to patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML). KDS-1001 is a study product created using certain immune cells called natural killer (NK) cells collected from a third-party donor.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
    Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5
  2. TIGIT Expression on Activated NK Cells Correlates with Greater Anti-Tumor Activity but Promotes Functional Decline upon Lung Cancer Exposure: Implications for Adoptive Cell Therapy and TIGIT-Targeted Therapies.
    Hasan MF, Croom-Perez TJ, Oyer JL, Dieffenthaller TA, et al · · 2023 · cited 25× · PMID 37345049 · DOI 10.3390/cancers15102712
  3. Beyond αβ T cells: NK, iNKT, and γδT cell biology in leukemic patients and potential for off-the-shelf adoptive cell therapies for AML.
    Kent A, Crump LS, Davila E. · · 2023 · cited 21× · PMID 37654497 · DOI 10.3389/fimmu.2023.1202950
  4. Maintenance strategies for relapse prevention and treatment.
    Geramita E, Hou JZ, Shlomchik WD, Ito S. · · 2024 · cited 2× · PMID 39644024 · DOI 10.1182/hematology.2024000589
  5. Parainfluenza Virus 5 V Protein Blocks Interferon Gamma-Mediated Upregulation of NK Cell Inhibitory Ligands and Improves NK Cell Killing of Neuroblastoma Cells.
    Shiffer EM, Oyer JL, Copik AJ, Parks GD. · · 2024 · cited 2× · PMID 39205244 · DOI 10.3390/v16081270
  6. PM21-particle stimulation augmented with cytokines enhances NK cell expansion and confers memory-like characteristics with enhanced survival.
    Oyer JL, Croom-Perez TJ, Hasan MF, Rivera-Huertas JA, et al · · 2024 · cited 2× · PMID 38711506 · DOI 10.3389/fimmu.2024.1383281

Verify or expand the search:

Other trials of Cyclophosphamide

Trials testing the same drug.

Other recruiting trials for Myeloid Malignancies

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing