Clinical trial · Observational
PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was closed due to the recent pandemic and enrollment challenges.
Summary
Brief summary (as posted)
Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pharmacokinetics | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG in Combination with N-803 | Biological | — | UNRESOLVED |
| N-803 alone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cohort A: CIS (either study)
- description
- Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
- interventionNames
- Biological: BCG in Combination with N-803
- label
- Cohort B: High-Grade Ta/T1 Papillary Disease (either study)
- description
- Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease
- interventionNames
- Biological: BCG in Combination with N-803
- label
- Cohort C: CIS (QUILT-3.032)
- description
- Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
- interventionNames
- Drug: N-803 alone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available