About this trial
This is a phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-75 years of age.
B-NHL: Failure of >/= 1 salvage line and failure of or ineligibility for CAR-T.
HL and T-NHL: Failure of >/= 1 salvage line or prior SCT.
ALL: Active disease (>5% of blasts or positive MRD at a level of >0.1% measured by multiparameter flow cytometry) after ≥ 2 two lines of therapy. Patients with B-ALL must have either failed of or be ineligible for CAR-T cell therapy. Patients who have mutations for which there are FDA approved targeted therapies (i.e., BCR-ABL) must also have received at least one of such agents.
Disqualifiers
Lymphoma or ALL in CR with no measurable sites of disease.
Major surgery <4 weeks prior to first dose of study drug.
Any other severe or uncontrolled disease or condition which mightincrease the risk associated with study participation.
Any other malignancy known to be active, with the exception of treated cervical intraepithelial neoplasia and non-melanoma skincancer.
Trial design
Single group
Treatments tested in this trial
Fludarabine
DrugGiven by IV
TGFBR2 KO CAR27/IL-15 NK cells
DrugGiven by IV
Cyclophosphamide
DrugGiven by IV
Treatment groups
Trial outcomes
Primary outcomes
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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