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

NCT04142359 | Terminated Results FDA Drug

• 1 other identifier: QUILT-3.032-2.005-PK
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Half-life (t½)

  Half-life (t½)

  Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

• Apparent (Extravascular) Volume of Distribution (Vz/F)

  Apparent (extravascular) volume of distribution (Vz/F)

  Study day 1 prior to dosing, and at post-bladder voiding (+15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

• Apparent (Extravascular) Clearance (CL/F)

  Apparent (extravascular) clearance (CL/F)

  Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

• Maximum Observed Concentration (Cmax)

  Maximum observed concentration (Cmax)

  Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

• Time of the Observed Maximum Concentration (Tmax)

  Time of the observed maximum concentration (Tmax)

  Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

• Area Under the Plasma Concentration Curve From Time 0 Through the Last Measurable Concentration (AUC0-t)

  Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t)

  Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

• Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinite Time (AUC0-inf)

  Area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)

  Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

Study Arms (3)

Cohort A: CIS (either study)

Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].

Biological: BCG in Combination with N-803

Cohort B: High-Grade Ta/T1 Papillary Disease (either study)

Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease

Biological: BCG in Combination with N-803

Cohort C: CIS (QUILT-3.032)

Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].

Drug: N-803 alone

Interventions

BCG in Combination with N-803 BIOLOGICAL

BCG in Combination with N-803

Also known as: N-803

Cohort A: CIS (either study); Cohort B: High-Grade Ta/T1 Papillary Disease (either study)

N-803 alone DRUG

N-803 alone

Cohort C: CIS (QUILT-3.032)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Six subjects from either Cohort A (either study) or Cohort C (QUILT-3.032) and six subjects from Cohort B (either study) will be sampled initially in this PK sub-study. Up to an additional 4 subjects from each cohort may also be sampled.

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.

Sponsors & Collaborators

• Altor BioScience: lead

Study Sites (6)

UCLA Department of Urology

Los Angeles, California, 90024, United States

Location

University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Adult & Pediatric Urology

Omaha, Nebraska, 68114, United States

Location

NYU Winthrop University Hospital Department of Urology

Garden City, New York, 11530, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

ALT-803

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Study Officials

• Chad Garner, PhD

  ImmunityBio, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 29, 2019
• Study Start: December 9, 2019
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)