PharmacokineticsNCT04142359
PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)
An observational study of Pharmacokinetics, run by Altor BioScience at 6 sites in United States.
Trial summary
Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- BCG in Combination with N-803 and N-803 alone
- How many people
- 1 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Dec 2019to 6 Apr 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
NYU Winthrop University Hospital Department of Urology
Garden City, New York, 11530
UCLA Department of Urology
Los Angeles, California, 90024
University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Manhattan Medical Research
New York, New York, 10016
Adult & Pediatric Urology
Omaha, Nebraska, 68114
Virginia Urology
Richmond, Virginia, 23235
About this study
Official title: A Pharmacokinetic Sub-Study of QUILT-3.032 (CA ALT-803-01-16): A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer and QUILT-2.005: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)
Read the detailed description
QUILT-3.032 is a Phase 2, open-label, single-arm, three-cohort, multicenter study of intravesical BCG plus ALT-803 in patients with BCG unresponsive high grade NMIBC. Patients will be enrolled into one of three study cohorts. Cohort A will enroll 80 patients who have histologically confirmed presence of BCG-unresponsive carcinoma in situ (CIS) [with or without Ta or T1 disease]. Cohort B will enroll 80 patients who have histologically confirmed BCG-unresponsive high-grade Ta or T1 disease. Cohort C will enroll up to 23 patients who also have histologically confirmed presence of BCG-unresponsive CIS [with or without Ta/T1 papillary disease]. Patients in Cohorts A and B will receive ALT-803 plus BCG combination treatment. Patients in Cohort C will receive ALT-803 alone. Enrollment of Cohort C will start once the enrollment of Cohort A is complete. Cohorts A, B, and C are independent study cohorts and will be separately evaluated for efficacy. All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus ALT-803 or ALT-803 alone weekly for 6 consecutive weeks during the induction treatment period.
QUILT-2.005 is a phase 2b, randomized, two-cohort, open-label, multicenter study of intravesical ALT-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC. Patients will be enrolled into one of two study cohorts and randomized into two arms to be treated with either ALT-803 plus BCG or BCG alone. Cohort A will initially enroll 366 patients who have histologically confirmed CIS (with or without Ta/T1 papillary disease). Cohort B will initially enroll 230 patients who have histologically confirmed high-grade papillary Ta/T1 disease only. Cohorts A and B are two independent study cohorts and will be evaluated separately for efficacy.
PK sub-study: Blood samples to determine serum levels of ALT-803 will be collected on 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. 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. Up to an additional 4 subjects for each cohort may also be sampled. Patients enrolled in QUILT 2.005 must have been randomized to receive ALT-803 plus BCG to be eligible for the PK sub-study.
- Conditions
- Pharmacokinetics
- Being tested
- BCG in Combination with N-803, N-803 alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG in Combination with N-803Biological
Also called N-803
BCG in Combination with N-803
N-803 aloneDrug
N-803 alone
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: CIS (either study) | Patients with histologically confirmed presence of BCG-unresponsive CIS, [with or without Ta/T1 papillary disease]. Receives: 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 Receives: 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]. Receives: Drug: N-803 alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Half-life (t½)
Half-life (t½)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start9 Dec 2019
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Why it stopped: Study was closed due to the recent pandemic and enrollment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altor BioScience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chad Garner, PhD, Study director, ImmunityBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142359
- Sponsor's protocol ID
- QUILT-3.032-2.005-PK
- Status last verified
- Jan 2021
- First submitted
- 23 Oct 2019
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Sub-Study of QUILT-3.032 (CA ALT-803-01-16): A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer and QUILT-2.005: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04142359
- Acronym / sponsor ID
- QUILT-3.032-2.005-PK
- Conditions
- Pharmacokinetics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was closed due to the recent pandemic and enrollment challenges.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Altor BioScienceIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)
Detailed description
QUILT-3.032 is a Phase 2, open-label, single-arm, three-cohort, multicenter study of intravesical BCG plus ALT-803 in patients with BCG unresponsive high grade NMIBC. Patients will be enrolled into one of three study cohorts. Cohort A will enroll 80 patients who have histologically confirmed presence of BCG-unresponsive carcinoma in situ (CIS) [with or without Ta or T1 disease]. Cohort B will enroll 80 patients who have histologically confirmed BCG-unresponsive high-grade Ta or T1 disease. Cohort C will enroll up to 23 patients who also have histologically confirmed presence of BCG-unresponsive CIS [with or without Ta/T1 papillary disease]. Patients in Cohorts A and B will receive ALT-803 plus BCG combination treatment. Patients in Cohort C will receive ALT-803 alone. Enrollment of Cohort C will start once the enrollment of Cohort A is complete. Cohorts A, B, and C are independent study cohorts and will be separately evaluated for efficacy. All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus ALT-803 or ALT-803 alone weekly for 6 consecutive weeks during the induction treatment period.
QUILT-2.005 is a phase 2b, randomized, two-cohort, open-label, multicenter study of intravesical ALT-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC. Patients will be enrolled into one of two study cohorts and randomized into two arms to be treated with either ALT-803 plus BCG or BCG alone. Cohort A will initially enroll 366 patients who have histologically confirmed CIS (with or without Ta/T1 papillary disease). Cohort B will initially enroll 230 patients who have histologically confirmed high-grade papillary Ta/T1 disease only. Cohorts A and B are two independent study cohorts and will be evaluated separately for efficacy.
PK sub-study: Blood samples to determine serum levels of ALT-803 will be collected on 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. 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. Up to an additional 4 subjects for each cohort may also be sampled. Patients enrolled in QUILT 2.005 must have been randomized to receive ALT-803 plus BCG to be eligible for the PK sub-study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: CIS (either study) | – | Biological: BCG in Combination with N-803Patients with histologically confirmed presence of BCG-unresponsive CIS, [with or without Ta/T1 papillary disease]. |
| Cohort B: High-Grade Ta/T1 Papillary Disease (either study) | – | Biological: BCG in Combination with N-803Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease |
| Cohort C: CIS (QUILT-3.032) | – | Drug: N-803 alonePatients with histologically confirmed presence of BCG-unresponsive CIS, [with or without Ta/T1 papillary disease]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG in Combination with N-803Also: N-803BCG in Combination with N-803 | Biological | Cohort A: CIS (either study), Cohort B: High-Grade Ta/T1 Papillary Disease (either study) |
| N-803 aloneN-803 alone | Drug | Cohort C: CIS (QUILT-3.032) |
Primary outcome
Half-life (t½)
Time frame: 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.
Half-life (t½)
Apparent (Extravascular) Volume of Distribution (Vz/F)
Time frame: 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) Clearance (CL/F)
Time frame: 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)
Maximum Observed Concentration (Cmax)
Time frame: 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)
Time of the Observed Maximum Concentration (Tmax)
Time frame: 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)
Area Under the Plasma Concentration Curve From Time 0 Through the Last Measurable Concentration (AUC0-t)
Time frame: 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 Extrapolated to Infinite Time (AUC0-inf)
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Garner, PhD study director
ImmunityBio, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics, run by Altor BioScience at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Half-life (t½) (time frame: 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.