Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04650451|
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : April 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|HER-2 Gene Amplification HER2-positive Gastric Cancer HER2-positive Breast Cancer HER-2 Protein Overexpression Solid Tumor, Adult||Biological: chimeric antigen receptor (CAR) T cell therapy||Phase 1|
- Phase 1: Cell dose escalation to identify the maximum dose of BPX-603 administered without or with rimiducid (fixed dose at 0.4 mg/kg per infusion). 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 7, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||January 2, 2025|
Experimental: 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.
Biological: chimeric antigen receptor (CAR) T cell therapy
HER2-targeted dual-switch CAR-T cells
- Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of BPX-603 [ Time Frame: 35 days from time of BPX-603 infusion ]Dose limiting toxicities are defined as BPX-603-related adverse events.
- Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) [ Time Frame: through Phase 1 completion, up to 2 years ]Identify the optimal dose of BPX-603 for Phase 2.
- Persistence of HER2-CAR T cells (cell counts) [ Time Frame: measured over time from baseline through study completion, up to 5 years ]The persistence over time of BPX-603 CAR T cells in the peripheral blood as determined by flow cytometry (% CAR+ cells).
- Expansion of HER2-CAR T cells (vector copy number) [ Time Frame: measured over time from baseline through study completion, up to 5 years ]The expansion over time of BPX-603 CAR T cells in the peripheral blood as determined by qPCR (copies/ug gDNA).
- Antitumor activity of BPX-603 [ Time Frame: through study completion, up to 5 years ]Overall response rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04650451
|Contact: BPX-603 Study Teamfirstname.lastname@example.org|
|United States, California|
|City of Hope National Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Yuan Yuan, MD|
|Principal Investigator: Yuan Yuan, MD|
|United States, Georgia|
|Winship Cancer Institute at Emory University||Recruiting|
|Atlanta, Georgia, United States, 322972|
|Contact: Mehmet Akce, MD|
|Principal Investigator: Mehmet Akce, MD|
|United States, New Jersey|
|John Theurer Cancer Center, Hackensack University Medical Center||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: Martin Gutierrez, MD|
|Principal Investigator: Martin Gutierrez, MD|
|United States, New York|
|Roswell Park Cancer Institute||Not yet recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Ann Grand'Maison, MD|
|Principal Investigator: Ann Grand'Maison, MD|
|United States, Rhode Island|
|Roger Williams Medical Center||Not yet recruiting|
|Providence, Rhode Island, United States, 02908|
|Contact: Bharti Rathore, MD|
|Principal Investigator: Bharti Rathore, MD|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ecaterina I Dumbrava, MD|
|Principal Investigator: Ecaterina I Dumbrava, MD|