Nkarta Seeks Protocol Amendments for Clinical Trials of CAR NK Cell Therapy
1 report, 1 independent
Updated Sun 00:00
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What happened
Nkarta is seeking protocol amendments regarding its clinical trials for autoimmune disease programs. The company is developing an allogeneic, off-the-shelf CAR NK cell therapy. Under the amended protocol, patients can receive off-the-shelf cells after only a two-hour observation period and return home, moving away from previous requirements like patient-by-patient dosing staggers and 24-hour observation.
From dailypolitical.com
Why it matters
The company is evaluating a potentially more compressed dosing regimen with regulators. The amendments seek to allow for outpatient administration of the cell therapy, which was a key focus as Nkarta transitioned from oncology into autoimmune disease indications.
From dailypolitical.com
Who's involved
- FDARegulator overseeing the company's clinical trials
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The entities involved
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