PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)

Stopped early

Conditions studied: Pharmacokinetics

In brief

Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)

Key facts

Study ID

NCT04142359

Run by

Altor BioScience

People needed

1

Starts

2019-12-09

Expected to finish

2020-04-06

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Only subjects who are eligible for and have entered into protocol QUILT-3.032 or QUILT-2.005 may participate in this sub-study.
• Patients enrolled in QUILT-2.005 must have been randomized to receive ALT-803 plus BCG to participate in this sub-study.

You may not qualify if…

• Refusal to provide voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations.
• Loss of ≥ 475 mL blood volume or blood transfusion of any blood product within 3 months prior to screening.

Where it is running

• UCLA Department of Urology — Los Angeles, California, United States
• University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Adult & Pediatric Urology — Omaha, Nebraska, United States
• NYU Winthrop University Hospital Department of Urology — Garden City, New York, United States
• Manhattan Medical Research — New York, New York, United States
• Virginia Urology — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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