Trials / Active Not Recruiting
Active Not RecruitingNCT04137536
A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find the safest dose and identify any bad side effects of EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic cancer who have already received first-line standard chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | anti-EGFR-bispecific antibody armed activated T-cells | Phase I: * First 3 participants, twice weekly infusions of 10\^10 EGFR BATs infusions * If there is toxicity in 0 or 1 of 3 participants, 3 additional participants will be added to the dose level of up to 10\^10. * If \>/= 2 of 6 participants experience DLTs, then the dose will be reduced to 7.5 x 10\^9 per infusion * If only 0 or 1 participants has toxicity in the first 6, then the study will proceed to enroll in the expansion cohort Expansion cohort: \- 8 infusions of 7.5 x 10\^9 or 10\^10 EGFR BATs in 22 evaluable participants (including the 6 participants treated at the maximum tolerated dose in Phase I) |
Timeline
- Start date
- 2019-10-17
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2019-10-24
- Last updated
- 2025-05-15
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04137536. Inclusion in this directory is not an endorsement.