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NCT03696030
HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases
Phase 1 trial testing Chimeric Antigen Receptor T-Cell Therapy in Malignant Neoplasm in 24 participants. Participants enrolled and being followed up; not accepting new ones.
19 February 2026
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 31 August 2018 |
| Primary completion | 19 February 2026 |
| Estimated completion | 19 February 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Chimeric Antigen Receptor T-Cell Therapy — full drug profile →
Conditions studied
- Malignant Neoplasm — all drugs for Malignant Neoplasm →
- Metastatic Malignant Neoplasm in the Brain — all drugs for Metastatic Malignant Neoplasm in the Brain →
- Metastatic Malignant Neoplasm in the Leptomeninges — all drugs for Metastatic Malignant Neoplasm in the Leptomeninges →
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
City of Hope Medical Center
Who can join
Adults 18 to 75, any sex, with Malignant Neoplasm or Metastatic Malignant Neoplasm in the Brain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies the side effects and best dose of HER2-CAR T cells in treating patients with cancer that has spread to the brain or leptomeninges and has come back (recurrent). HER2-CAR T cells delivered into the ventricles of the brain may recognize and kill tumor cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
CAR-T cell therapy: current limitations and potential strategies.
Sterner RC, Sterner RM. · · 2021 · cited 1883× · PMID 33824268 · DOI 10.1038/s41408-021-00459-7 -
CAR T Cells for Solid Tumors: New Strategies for Finding, Infiltrating, and Surviving in the Tumor Microenvironment.
Martinez M, Moon EK. · · 2019 · cited 653× · PMID 30804938 · DOI 10.3389/fimmu.2019.00128 -
Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y -
CAR T Cell Therapy for Solid Tumors: Bright Future or Dark Reality?
Wagner J, Wickman E, DeRenzo C, Gottschalk S. · · 2020 · cited 284× · PMID 32979309 · DOI 10.1016/j.ymthe.2020.09.015 -
Engineered T Cell Therapy for Cancer in the Clinic.
Zhao L, Cao YJ. · · 2019 · cited 275× · PMID 31681259 · DOI 10.3389/fimmu.2019.02250 -
Differentiation and Regulation of T<sub>H</sub> Cells: A Balancing Act for Cancer Immunotherapy.
Basu A, Ramamoorthi G, Albert G, Gallen C, et al · · 2021 · cited 260× · PMID 34012451 · DOI 10.3389/fimmu.2021.669474 -
The Crosstalk Between Tumor Cells and the Immune Microenvironment in Breast Cancer: Implications for Immunotherapy.
Salemme V, Centonze G, Cavallo F, Defilippi P, et al · · 2021 · cited 194× · PMID 33777750 · DOI 10.3389/fonc.2021.610303 -
CAR T cells for brain tumors: Lessons learned and road ahead.
Akhavan D, Alizadeh D, Wang D, Weist MR, et al · · 2019 · cited 172× · PMID 31355493 · DOI 10.1111/imr.12773
Verify or expand the search:
- PubMed search for NCT03696030
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Malignant Neoplasm
Currently open trials in the same condition.
- NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
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- NCT07247110 — A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) · Phase 1 · recruiting
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Other City of Hope Medical Center trials
Trials by the same sponsor.
- NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
- NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
- NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
- NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
- NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03696030 (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 City of Hope Medical Center
- Last refreshed: 13 April 2025
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/NCT03696030.
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