Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 1/2, Open-Label, Multicenter, Non-Randomized, Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) In Subjects With Previously Treated Advanced HER2-Positive Solid Tumors

Details

  • 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.

Keywords

HER-2 Gene Amplification HER2-positive Gastric Cancer HER2-positive Breast Cancer HER-2 Protein Overexpression Solid Tumor, Adult HER2 CAR-T breast cancer solid tumors gastric cancer Stomach Neoplasms chimeric antigen receptor (CAR) T cell therapy HER2-targeted dual-switch CAR-T cells

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego (UCSD) not yet accepting patients
    La Jolla California 92093 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bellicum Pharmaceuticals
ID
NCT04650451
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 220 study participants
Last Updated