Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
18 Years and older, Male and Female
BPX603-201A (primary)
NCI-2021-00052
Summary
This is a Phase 1/2, open-label, multicenter, non-randomized study to investigate the
safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells,
BPX-603, administered with rimiducid to subjects with previously treated, locally
advanced or metastatic solid tumors which are HER2 amplified/overexpressed.
Objectives
- Phase 1: Cell dose escalation to identify the maximum dose of BPX-603 administered
without or with rimiducid. The first subject in each dose cohort will receive
BPX-603 alone (without rimiducid) in order to assess safety of the CAR-T
monotherapy.
- Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics
(including BPX-603 persistence and response to temsirolimus as applicable), and
clinical activity at the recommended dose for expansion (RDE) identified in Phase 1
in various HER2+ solid tumors.
- During Phase 1 or 2, temsirolimus (single IV dose at 25 mg) may be administered
following BPX-603 infusion in response to treatment-emergent toxicity in order to
activate the iRC9 safety switch.
Eligibility
- Documented evidence of HER2 amplification/overexpression by local testing.
- Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic HER2+ solid tumor malignancy for which standard treatment is no longer effective, does not exist, or subject is ineligible.
- Subjects with a solid tumor malignancy for which HER2-targeted therapy is approved as a standard treatment (e.g., breast, gastric cancers) must have received prior treatment with approved HER2-directed therapy.
- Measurable disease (at least one target lesion) per RECIST v1.1.
- Life expectancy > 12 weeks.
- ECOG 0-1.
- Adequate organ function.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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