← Back to all trials
Recruiting
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
Conditions: Myeloid Malignancies
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 42
Sponsor: M.D. Anderson Cancer Center
Location: The University of Texas M. D. Anderson Cancer Center Houston Texas
Summary
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
Inclusion Criteria:
1. Diagnosis: Age 18-80 years with diagnosis of:
1. 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.
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 \
Source: ClinicalTrials.gov (NCT06930651). StuddyBuddy aggregates publicly available trial information.