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Phase I/II Study for Relapsed/Refractory Myeloid Malignancies

This study is testing a new treatment for people aged 18 to 80 with relapsed or refractory myeloid malignancies (cancers of the blood and bone marrow). The treatment involves a one-time infusion of special immune cells called TGFBR2 KO CAR27/IL-15 NK cells, which are designed to target cancer. Before receiving these cells, participants will get chemotherapy with Dexamethasone, Cyclophosphamide, Fludarabine, and Decitabine. The main goals are to find the safest dose of the new cell therapy and to see how well it works in shrinking the cancer. This is a targeted therapy, meaning it aims to specifically attack cancer cells.

Study design
This is a Phase I/II, open-label study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll up to 42 participants.
What's involved
The regimen involves lymphodepleting and priming chemotherapy, followed by a one-time infusion of the study cells.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored throughout the study, for an average of 1 year. Response rates will be measured at 30 days from the cell infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06930651

A Phase I/II Study of CAR.70-Engineered IL15-Transduced Cord Blood-Derived NK Cells With TGF-beta Receptor 2 (TGFBR2) Knock Out in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Myeloid Malignancies

Recruiting
PHASE1Ages 18–80InterventionalTreatment
M.D. Anderson Cancer Center
~42 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:DexamethasoneCyclophosphamideFludarabineDecitabineTGFBR2 KO CAR27/IL-15 NK cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
+2 more outcomes measured

Conditions

Myeloid Malignancies

Explore related trials

Acute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic SyndromeCD70 Antigen

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Nicholas Short, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Nicholas Short, MD
[email protected]
(713) 563-4485
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with a mutation that is targetable with an FDA-approved targeted therapy should have received at least one on these agents. . "Treated secondary AML "includes patients with prior diagnosis of a myeloid neoplasm (e.g. MDS) who received hypomethylating agents for this disease and subsequently progressed to AML. These patients must have received all of the following: a hypomethylating agent + venetoclax and intensive chemotherapy (if a suitable candidate for intensive therapy). These patients may be enrolled at the time of AML diagnosis if they have already received all of the treatments above for their antecedent myeloid neoplasm. 2. MDS that is intermediate, high-risk or very-high risk by the Revised International Prognostic Scoring System (R-IPSS)
Bone marrow blasts must be \>5%.
The disease must have either 1.) not have responded to at least 4 cycles of a hypomethylating agent or 2.) progressed or relapsed, regardless of the number of cycles received 3. CMML-1 or CMML-2
Bone marrow blasts must be \>5%.
The disease must have either 1.) not have responded to at least 4 cycles of a hypomethylating agent or 2.) progressed or relapsed, regardless of the number of cycles received 2. CD70 expression \>10% measured by immunohistochemistry or multiparameter flow cytometry 3. Performance status \</=2 (ECOG Scale) 4. Adequate liver, cardiac, renal and pulmonary function as defined by the following criteria:

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  • Response rates (AML cohort)30 days from CAR infusion

    Rate of complete remission (CR) + CR with incomplete hematologic recovery (CRi) + CR with CR with partial hematologic recovery (CRh)

  • Response rates (MDS/CMML) cohort30 days from CAR infusion

    Rate of CR + partial remission (PR) + CR with limited count recovery (CRL), CRh, hematologic improvement (HI) for MDS; rate of CR + PR + marrow CR (mCR) + clinical benefit (CB) for CMML