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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04650451
Other study ID # BPX603-201A
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
Start date December 7, 2020
Est. completion date January 2, 2027

Study information

Verified date April 2023
Source Bellicum Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

- 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Biological:
chimeric antigen receptor (CAR) T cell therapy
HER2-targeted dual-switch CAR-T cells

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Bellicum Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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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