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

Completed · Phase 2

Conditions studied: Myeloid Malignancies, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT05115630

Run by

M.D. Anderson Cancer Center

People needed

24

Starts

2022-04-08

Expected to finish

2025-05-15

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ages 18 to 70 years old at the time of enrollment.
• Patients weighing at least 42 kg
• Patient with the hematologic malignancies described below, as well as an HLA matched related donor, HLA matched unrelated donor, a haploidentical related donor, or a one antigen mismatched unrelated donor. HLA matching includes HLA A, B, C, and DR-B1.
• Patients must have one of the following diseases:
• Acute myeloid leukemia (AML):
• a. With one or more high-risk features defined as: (i) Greater than 1 cycle of induction therapy required to achieve remission; (ii) Preceding myelodysplastic syndrome (MDS);
• Presence of FLT3 mutations or internal tandem duplication or other mutations designated as adverse-risk by the ELN Leukemia Net AML Classification (see Appendix 2):
• Adverse:
• t(6;9)(p23;q34.1); DEK-NUP214
• t(v;11q23.3); KMT2A rearranged
• t(9;22)(q34.1;q11.2); BCR-ABL1
• inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2,MECOM(EVI1)
• -5 or del(5q); -7; -17/abn(17p)
• Complex karyotype, monosomal karyotype
• Wild-type NPM1 and FLT3-ITDhigh
• Mutated RUNX1
• Mutated ASXL1
• Mutated TP53 (iv) FAB M6 or M7 classification; (v) Adverse cytogenetics: -5, del 5q, -7, del7q, abnormalities involving 3q, 9q, 11q, 20q, 21q, 17, +8 or complex karyotype [> 3 abnormalities]; or other mutations designated as adverse-risk by the ELN criteria; (vi) Treatment-related AML (vii) Primary induction failure with partial response to therapy who achieve adequate cytoreduction (viii) Aplastic/hypoplastic marrow with or without detectable persistent disease after induction chemotherapy or after salvage chemotherapy.
• (ix) Have minimal residual disease by flow cytometry, FISH, detection of disease related mutations or cytogenetic abnormality after first course of induction chemotherapy (x) Have relapsed after prior allogeneic hematopoietic transplant
• AND
• b. Patients must be in one of the following (i) CR: complete remission, (ii) CRi: CR with incomplete hematologic recovery, or (iii) MLFS: morphological leukemia-free state with less than 5% bone marrow blasts.
• (iv) If not in either of the above i-iii, then may be in either of the following:
• Primary induction failure with partial response to therapy who achieve adequate cytoreduction
• Aplastic/hypoplastic marrow with or without detectable persistent disease after induction chemotherapy or after salvage chemotherapy
• Myelodysplastic syndromes (MDS):

You may not qualify if…

• HIV positive; active hepatitis B or C.
• Uncontrolled infections; PI is the final arbiter of this criterion.
• Liver cirrhosis.
• CNS involvement within 3 months prior to the transplant.
• Positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
• Inability to comply with medical therapy or follow-up.
• Patient with a known history of allergic reactions to any constituents of the product, including a known history of allergic reactions to cellular products or DMSO.
• Other malignancy/cancer diagnosis with active disease or in remission and <2 years ago, not including nonmelanoma skin cancer
• Requiring systemic corticosteroids with prednisone dose >10 mg or equivalent.
• KDS-1001 Donor specific antibodies (dsa) >3000 MFI units or C1q positive

Where it is running

• M D Anderson Caner Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.