Who is sponsoring NCT04650451?

NCT04650451 is sponsored by Bellicum Pharmaceuticals.

What drugs are being tested in NCT04650451?

Interventions in NCT04650451: chimeric antigen receptor (CAR) T cell therapy.

What condition does NCT04650451 study?

NCT04650451 studies HER-2 Gene Amplification, HER2-positive Gastric Cancer, HER2-positive Breast Cancer, HER-2 Protein Overexpression, Solid Tumor, Adult.

Is NCT04650451 still recruiting?

NCT04650451 is currently suspended. Last updated 20 April 2023.

Last reviewed 2023-04-20 · How we verify

NCT04650451

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Suspended Phase 1 Last updated 20 April 2023

What this trial tests

Phase 1 trial testing chimeric antigen receptor (CAR) T cell therapy in HER-2 Gene Amplification in 220 participants. Suspended.

Timeline

7 December 2020

Primary endpoint
31 December 2025

2 January 2027

Quick facts

Lead sponsor	Bellicum Pharmaceuticals
Phase	Phase 1
Status	Suspended
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	220
Start date	7 December 2020
Primary completion	31 December 2025
Estimated completion	2 January 2027
Sites	7 locations across United States

Drugs / interventions tested

chimeric antigen receptor (CAR) T cell therapy

Conditions studied

HER-2 Gene Amplification — all drugs for HER-2 Gene Amplification →
HER2-positive Gastric Cancer — all drugs for HER2-positive Gastric Cancer →
HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →
HER-2 Protein Overexpression — all drugs for HER-2 Protein Overexpression →

Sponsor

Bellicum Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with HER-2 Gene Amplification or HER2-positive Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting HER2-positive breast cancer: advances and future directions.
Swain SM, Shastry M, Hamilton E. · · 2023 · cited 703× · PMID 36344672 · DOI 10.1038/s41573-022-00579-0
Gastric cancer treatment: recent progress and future perspectives.
Guan WL, He Y, Xu RH. · · 2023 · cited 639× · PMID 37245017 · DOI 10.1186/s13045-023-01451-3
CAR-cell therapy in the era of solid tumor treatment: current challenges and emerging therapeutic advances.
Maalej KM, Merhi M, Inchakalody VP, Mestiri S, et al · · 2023 · cited 421× · PMID 36717905 · DOI 10.1186/s12943-023-01723-z
Current advances and challenges in CAR T-Cell therapy for solid tumors: tumor-associated antigens and the tumor microenvironment.
Yan T, Zhu L, Chen J. · · 2023 · cited 132× · PMID 36707873 · DOI 10.1186/s40164-023-00373-7
Harnessing the potential of CAR-T cell therapy: progress, challenges, and future directions in hematological and solid tumor treatments.
Dagar G, Gupta A, Masoodi T, Nisar S, et al · · 2023 · cited 130× · PMID 37420216 · DOI 10.1186/s12967-023-04292-3
Proximity-Based Modalities for Biology and Medicine.
Liu X, Ciulli A. · · 2023 · cited 113× · PMID 37521793 · DOI 10.1021/acscentsci.3c00395
Emerging Targeted Therapies for HER2-Positive Breast Cancer.
Mercogliano MF, Bruni S, Mauro FL, Schillaci R. · · 2023 · cited 95× · PMID 37046648 · DOI 10.3390/cancers15071987
Assessing the Future of Solid Tumor Immunotherapy.
Guha P, Heatherton KR, O'Connell KP, Alexander IS, et al · · 2022 · cited 85× · PMID 35327456 · DOI 10.3390/biomedicines10030655

Verify or expand the search:

Other recruiting trials for HER-2 Gene Amplification

Currently open trials in the same condition.

NCT04660929 — CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors · Phase 1 · active not recruiting

Other Bellicum Pharmaceuticals trials

Trials by the same sponsor.

NCT03699475 — Study of Haplo-HSCT + Rivogenlecleucel vs Haplo-HSCT + Post Transplant Cyclophosphamide in Patients With AML or MDS · Phase 2, PHASE3 · terminated
NCT02743611 — Safety & Activity of Controllable PRAME-TCR Therapy in Previously Treated AML/MDS or Metastatic Uveal Melanoma · Phase 1, PHASE2 · terminated
NCT03639844 — BPX-501 T Cells Infused Post Stem Cell Transplant in Pediatrics With Non-Malignant Disorders Ineligible for BPU004 Study · no longer available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04650451 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bellicum Pharmaceuticals
Last refreshed: 20 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04650451.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing