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

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04650451
Protocol IDs
BPX603-201A (primary)
NCI-2021-00052
Study Sponsor
Bellicum Pharmaceuticals

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 (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.

Eligibility

  1. Documented evidence of HER2 amplification/overexpression by local testing.
  2. 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.
  3. 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.
  4. Measurable disease (at least one target lesion) per RECIST v1.1.
  5. Life expectancy > 12 weeks.
  6. ECOG 0-1.
  7. 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... Click here to learn more about clinical trials.
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