Last reviewed · How we verify
NCT04510051
CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurrent or Refractory Brain Tumors in Children
Phase 1 trial testing Cyclophosphamide in Malignant Brain Neoplasm in 18 participants. Currently enrolling.
24 February 2027
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 4 December 2020 |
| Primary completion | 24 February 2027 |
| Estimated completion | 24 February 2027 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes
Conditions studied
- Malignant Brain Neoplasm — all drugs for Malignant Brain Neoplasm →
- Recurrent Malignant Brain Neoplasm — all drugs for Recurrent Malignant Brain Neoplasm →
- Refractory Malignant Brain Neoplasm — all drugs for Refractory Malignant Brain Neoplasm →
Sponsor
City of Hope Medical Center
Who can join
Adults 4 to 25, any sex, with Malignant Brain Neoplasm or Recurrent Malignant Brain Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial investigates the side effects of chemotherapy and cellular immunotherapy in treating children with IL13Ralpha2 positive brain tumors that have come back after a period of improvement (recurrent) or do not respond to treatment (refractory). Cellular immunotherapy (IL13(EQ)BBzeta/CD19t+ T cells) are brain-tumor specific cells that may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many patients with brain tumor respond to treatment, but then the tumor starts to grow again. Giving chemotherapy in combination with cellular immunotherapy may kill more tumor cells and improve the outcome of treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Locoregional delivery of IL-13Rα2-targeting CAR-T cells in recurrent high-grade glioma: a phase 1 trial.
Brown CE, Hibbard JC, Alizadeh D, Blanchard MS, et al · · 2024 · cited 234× · PMID 38454126 · DOI 10.1038/s41591-024-02875-1 -
CAR-T Therapies in Solid Tumors: Opportunities and Challenges.
Guzman G, Reed MR, Bielamowicz K, Koss B, et al · · 2023 · cited 121× · PMID 36853475 · DOI 10.1007/s11912-023-01380-x -
CAR-T cell combination therapy: the next revolution in cancer treatment.
Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6 -
Cell therapies in the clinic.
Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214 -
Development of GPC2-directed chimeric antigen receptors using mRNA for pediatric brain tumors.
Foster JB, Griffin C, Rokita JL, Stern A, et al · · 2022 · cited 45× · PMID 36167467 · DOI 10.1136/jitc-2021-004450 -
Recent Advances in IL-13Rα2-Directed Cancer Immunotherapy.
Knudson KM, Hwang S, McCann MS, Joshi BH, et al · · 2022 · cited 45× · PMID 35464460 · DOI 10.3389/fimmu.2022.878365 -
Current Landscape of Cancer Immunotherapy: Harnessing the Immune Arsenal to Overcome Immune Evasion.
Mitra A, Kumar A, Amdare NP, Pathak R. · · 2024 · cited 34× · PMID 38785789 · DOI 10.3390/biology13050307 -
Next-generation chimeric antigen receptors for T- and natural killer-cell therapies against cancer.
Li Y, Rezvani K, Rafei H. · · 2023 · cited 29× · PMID 37548050 · DOI 10.1111/imr.13255
Verify or expand the search:
- PubMed search for NCT04510051
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cyclophosphamide
Trials testing the same drug.
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07509008 — Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cells Delivered Intraperitoneally For The Manageme · Phase 1, PHASE2 · not yet recruiting
- NCT07444632 — Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/ · Phase 1 · not yet recruiting
- NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
- NCT07437963 — Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatmen · Phase 1, PHASE2 · not yet recruiting
Other recruiting trials for Malignant Brain Neoplasm
Currently open trials in the same condition.
- NCT07174661 — Educational Tools for the Improvement of Early Advance Care Planning in Adolescents and Young Adults With Advanced Solid · NA · recruiting
- NCT07339085 — Advanced Magnetic Resonance Imaging for the Identification of Recurrent Brain Tumors and Radiation Necrosis · NA · recruiting
- NCT07118176 — Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers · Phase 1 · recruiting
- NCT06788886 — Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases · NA · recruiting
- NCT06132685 — Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial · Phase 2 · recruiting
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 NCT04510051 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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: 5 March 2026
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/NCT04510051.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing