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

NCT04650451 | Suspended Phase 1 FDA Drug

• 1 other identifier: BPX603-201A
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

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

Keywords

HER2; CAR-T; breast cancer; solid tumors; gastric cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of BPX-603

  Dose limiting toxicities are defined as BPX-603-related adverse events.

  35 days from time of BPX-603 infusion

• Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)

  Identify the optimal dose of BPX-603 for Phase 2.

  through Phase 1 completion, up to 2 years

Secondary Outcomes (3)

• Persistence of HER2-CAR T cells (cell counts)

  measured over time from baseline through study completion, up to 5 years

• Expansion of HER2-CAR T cells (vector copy number)

  measured over time from baseline through study completion, up to 5 years

• Antitumor activity of BPX-603

  through study completion, up to 5 years

Study Arms (1)

HER2-targeted dual-switch CAR-T cells

EXPERIMENTAL

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.

Biological: chimeric antigen receptor (CAR) T cell therapy

Interventions

chimeric antigen receptor (CAR) T cell therapy BIOLOGICAL

HER2-targeted dual-switch CAR-T cells

Also known as: CAR-T, BPX-603, autologous CAR-T

HER2-targeted dual-switch CAR-T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• Bellicum Pharmaceuticals: lead

Study Sites (7)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California San Diego (UCSD)

La Jolla, California, 92093, United States

Location

Winship Cancer Institute at Emory University

Atlanta, Georgia, 322972, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Stomach Neoplasms

Interventions

Receptors, Chimeric Antigen; Automobiles

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Receptors, Artificial; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Antigen, T-Cell; Receptors, Antigen; Receptors, Immunologic; Receptors, Cytoplasmic and Nuclear; Motor Vehicles; Transportation; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 2, 2020
• Study Start: December 7, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): January 2, 2027
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

US (7)