A Phase I/II Study of CAR.70-Engineered IL15-Transduced Cord Blood-Derived NK Cells With TGF-beta… (NCT06930651) | Clinical Trial Compass
RecruitingPhase 1/2
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
United States42 participantsStarted 2025-09-03
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Diagnosis: Age 18-80 years with diagnosis of:
✓. Relapsed or refractory AML or "treated secondary AML"
✓. MDS that is intermediate, high-risk or very-high risk by the Revised International Prognostic Scoring System (R-IPSS)
✓. CMML-1 or CMML-2
✓. CD70 expression \>10% measured by immunohistochemistry or multiparameter flow cytometry
✓. Performance status \</=2 (ECOG Scale)
✓. Adequate liver, cardiac, renal and pulmonary function as defined by the following criteria:
✓. Total serum bilirubin \</=2 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
. Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection Note: Patients who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load.
✕. Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI
✕. Use of calcineurin inhibitors (e.g. tacrolimus) within the past 2 weeks
✕. Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before lymphodepletion, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator.