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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorM.D. Anderson Cancer Center

About this trial

The goal of this clinical research study is to find the recommended safe dose of TGFBR2 KO CAR27/IL-15 NK cells that can be given to patients with relapsed/refractory disease. The safety and effectiveness of this treatment will also be studied.

Eligibility criteria

Qualifiers

Relapsed or refractory AML or "treated secondary AML"

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.

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%.

Disqualifiers

Active grade III-V cardiac failure as defined by the New York Heart Association Criteria

Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment).

Active central nervous system leukemia

Known human immunodeficiency virus (HIV) seropositive, unless well-controlled on stable doses of anti-retroviral therapy.

Trial design

Treatments tested in this trial

  • Dexamethasone
  • Cyclophosphamide
  • Fludarabine
  • Decitabine
  • TGFBR2 KO CAR27/IL-15 NK cells

Treatment groups

42 Participants
are divided into 2 treatment groups

Sponsors and collaborators