Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction W… (NCT07137481) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Aggressive T Cell Hematological Malignancies
United States70 participantsStarted 2027-02-28
Plain-language summary
To determine the safety and efficacy (1-year PFS) of iC9/CD5CAR/IL-15 NK cells as consolidation in patients with aggressive T-cell malignances in first remission.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 18-80 years of age
✓. Patients with hematological malignancies with an expression of CD5 in the tumor sample of ≥ 30% measured by immunohistochemistry or flow cytometry.
✓. Patients must meet disease-specific eligibility criteria.
✓. Patients should be at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy.
✓. Localized radiotherapy to one or more disease sites is allowed.
✓. Karnofsky Performance Scale \> 50%.
✓. Adequate organ function:
✓. Renal: Serum creatinine ≤ 2.0 ULN or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) ≥ 30 ml/min/1.73 m2.
Exclusion criteria
✕2. Signed consent to long-term follow-up protocol PA17-0483.
✕. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
✕. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.
✕
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year