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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-07

Study Completion Date

2027-01-02

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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HER-2 Gene Amplification HER2-positive Gastric Cancer HER2-positive Breast Cancer HER-2 Protein Overexpression Solid Tumor, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HER2-targeted dual-switch CAR-T cells

Subjects will receive one dose of BPX-603 on Day 1, followed by rimiducid IV infusion weekly (as tolerated) starting on Day 8 and continued until treatment discontinuation criteria are met.

Group Type EXPERIMENTAL

chimeric antigen receptor (CAR) T cell therapy

Intervention Type BIOLOGICAL

HER2-targeted dual-switch CAR-T cells

Interventions

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chimeric antigen receptor (CAR) T cell therapy

HER2-targeted dual-switch CAR-T cells

Intervention Type BIOLOGICAL

Other Intervention Names

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CAR-T BPX-603 autologous CAR-T

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No