Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT04650451
Trial Phases:	Phase I	Protocol IDs:	BPX603-201A (primary) NCI-2021-00052
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Bellicum Pharmaceuticals
NCI Full Details:	http://clinicaltrials.gov/show/NCT04650451

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.

**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... Click here to learn more about clinical trials.