Solid Tumor, Adult Clinical Trial
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
Verified date | April 2023 |
Source | Bellicum Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 220 |
Est. completion date | January 2, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Winship Cancer Institute at Emory University | Atlanta | Georgia |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Chicago | Chicago | Illinois |
United States | City of Hope National Medical Center | Duarte | California |
United States | John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | University of California San Diego (UCSD) | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
Bellicum Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Persistence of HER2-CAR T cells (cell counts) | The persistence over time of BPX-603 CAR T cells in the peripheral blood as determined by flow cytometry (% CAR+ cells). | measured over time from baseline through study completion, up to 5 years | |
Secondary | Expansion of HER2-CAR T cells (vector copy number) | The expansion over time of BPX-603 CAR T cells in the peripheral blood as determined by qPCR (copies/ug gDNA). | measured over time from baseline through study completion, up to 5 years | |
Secondary | Antitumor activity of BPX-603 | Overall response rate | through study completion, up to 5 years |
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---|---|---|---|
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