Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
- 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.
- Symptomatic, untreated, or actively progressing central nervous system metastases.
- Prior CAR T cell or other genetically-modified T cell therapy.
- Impaired cardiac function or clinically significant cardiac disease.
- Symptomatic intrinsic lung disease or those with extensive tumor involvement of the lungs.
- Severe intercurrent infection.
- Pregnant or breastfeeding.
- Known HIV positivity.
- Phase 1: Cell dose escalation to identify the maximum dose of BPX-603 administered
without or with rimiducid (fixed dose at 0.4 mg/kg per infusion). 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.
Trial Phase Phase I
Trial Type Treatment
- Primary ID BPX603-201A
- Secondary IDs NCI-2021-00052
- Clinicaltrials.gov ID NCT04650451