Table 1.
Currently active/recruiting/completed pediatric immunotherapy clinical trials involving B7-H3. Those involving neuroblastoma patients are summarized by Pulido R. et al. [27].
| NCT Number | Title | Status | Study Results | Conditions | Interventions | Age | Phases | Locations |
|---|---|---|---|---|---|---|---|---|
| ClinicalTrials.gov Identifier: NCT05063357 |
131I-omburtamab Delivered by Convection-Enhanced Delivery in Patients With Diffuse Intrinsic Pontine Glioma |
Not yet recruiting |
No Results Available |
Diffuse Intrinsic Pontine Glioma | Drug: 131I-Omburtamab|Device: Convention Enhanced Delivery | 3 Years to 21 Years (Child, Adult) |
Phase 1 | Y-mAbs Therapeutics, Labcorp Corporation of America Holdings, Inc. Invicro, Burlington, North Carolina |
| ClinicalTrials.gov Identifier: NCT04167618 |
177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma |
Terminated | No Results Available |
Medulloblastoma, Childhood | Drug: 177Lu-DTPA-omburtamab | 3 Years to 19 Years (Child, Adult) |
Phase 1| Phase 2 |
Mayo Clinic, Rochester, MN, United States| Memorial Sloan Kettering Cancer Center, New York, NY, United States|Doernbecher Children’s Hospital, Portland, OR, United States|M.D. Anderson Cancer Center, Houston, TX, United States|Rigshospitalet, Børneonkologisk afsnit, Copenhagen, Denmark|Princess Máxima, Utrecht, Netherlands|Hospital Universitari Vall d’Hebron, Barcelona, Spain|Hospital Sant Joan de Déu de Barcelona, Barcelona, Spain|The Royal Marsden Hospital, London, United Kingdom|Great North Children’s Hospital, Newcastle, United Kingdom |
| ClinicalTrials.gov Identifier: NCT03275402 |
131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases |
Active, not recruiting |
No Results Available |
Neuroblastoma|CNS Metastases| Leptomeningeal Metastases |
Biological: 131I-omburtamab | up to 18 Years (Child, Adult) |
Phase 2| Phase 3 |
Children’s Hospital Los Angeles, Los Angeles, CA, United States|Riley Hospital for Children, Indianapolis, IN, United States|Memorial Sloan Kettering Cancer Center, New York, NY, United States|Nationwide Children’s Hospital, Columbus, OH, United States|M.D. Anderson Cancer Center, Houston, TX, United States|Rigshospitalet, København, Denmark| Department of Pediatric Oncology Fukushima Medical University Hospital, Fukushima City, Japan|Hospital Sant Joan de Déu, Barcelona, Spain |
| ClinicalTrials.gov Identifier: NCT04743661 |
131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma |
Active, not recruiting |
No Results Available |
Recurrent Medulloblastoma| Recurrent Ependymoma |
Drug: Irinotecan|Drug: Temozolomide|Drug: Bevacizumab|Drug: Omburtamab I-131|Drug: Liothyronine|Drug: SSKI|Drug: Dexamethasone|Drug: Antipyretic|Drug: Antihistamine|Drug: anti-emetics |
up to 21 Years (Child, Adult) |
Phase 2 | Children’s Hospital Los Angeles, Los Angeles, CA, United States|Memorial Sloan Kettering Cancer Center, New York, NY, United States|Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States |
| ClinicalTrials.gov Identifier: NCT01502917 |
Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy |
Completed | No Results Available |
Brain Cancer|Brain Stem Glioma | Drug: Radioactive iodine-labeled monoclonal antibody omburtamab|Radiation: External Beam Radiotherapy |
2 Years to 21 Years (Child, Adult) |
Phase 1 | Weill Medical College of Cornell University, New York, NY, United States|Memorial Sloan Kettering Cancer Center, New York, NY, United States |
| ClinicalTrials.gov Identifier: NCT05064306 |
131I-omburtamab for the Treatment of Central Nervous System/Leptomeningeal Neoplasms in Children and Young Adults | Available | No Results Available |
Central Nervous System/ Leptomeningeal Neoplasms |
Drug: 131I-omburtamab | Child, Adult, Older Adult |
Memorial Sloan Kettering Cancer Center, New York, NY, United States | |
| ClinicalTrials.gov Identifier: NCT04022213 |
A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum | Recruiting | No Results Available |
Desmoplastic Small Round Cell Tumor|Peritoneal Cancer| Peritoneal Carcinoma |
Drug: 131 I-omburtamab|Radiation: WAP-IMRT | 1 Year and older (Child, Adult, Older Adult) |
Phase 2 | Memorial Sloan Kettering Cancer Center, New York, NY, United States |
| ClinicalTrials.gov Identifier: NCT00089245 |
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer |
Active, not recruiting |
No Results Available |
Brain and Central Nervous System Tumors|Neuroblastoma| Sarcoma |
Drug: Iodine I 131 MOAB 8H9 | Child, Adult, Older Adult |
Phase 1 | Memorial Sloan Kettering Cancer Center, New York, NY, United States |
| ClinicalTrials.gov Identifier: NCT04185038 |
Study of B7-H3-Specific CAR-T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors |
Recruiting | No Results Available |
Central Nervous System Tumor|Diffuse Intrinsic Pontine Glioma|Diffuse Midline Glioma|Ependymoma| Medulloblastoma, Childhood|Germ Cell Tumor|Atypical Teratoid/Rhabdoid Tumor| Primitive Neuroectodermal Tumor|Choroid Plexus Carcinoma|Pineoblastoma, Childhood|Glioma |
Biological: SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cel |
1 Year to 26 Years (Child, Adult) | Phase 1 | Seattle Children’s Hospital Seattle, WA, United State |
| ClinicalTrials.gov Identifier: NCT05768880 |
Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR-T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors |
Not yet recruiting |
No Results Available |
Diffuse Intrinsic Pontine Glioma|Diffuse Midline Glioma|Recurrent CNS Tumor, Adult|Recurrent, CNS Tumor, Childhood|Refractory Primary Malignant Central Nervous System Neoplasm |
Biological: SC-CAR4BRAIN | 1 Year to 26 Years (Child, Adult) | Phase 1 | Seattle Children’s Hospital Seattle, WA, United States |
| ClinicalTrials.gov Identifier: NCT02982941 |
Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors | Completed | No Results Available |
Neuroblastoma| Rhabdomyosarcoma| Osteosarcoma| Ewing Sarcoma|Wilms Tumor|Desmoplastic Small Round Cell Tumor |
Drug: Enoblituzumab | 1 Year to 35 Years (Child, Adult) | Phase 1 | Lucile Packard Children’s Hospital, Stanford, Palo Alto, California; National Cancer Institute, Center for Cancer Research, Bethesda, Maryland; Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania; Texas Children’s Hospital Houston, Texas; Seattle Children’s, Seattle, Washington; University of Wisconsin, American Family Children’s Hospital, Madison, Wisconsin |
| ClinicalTrials.gov Identifier: NCT04897321 |
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR) | Recruiting | No Results Available |
Pediatric Solid Tumor| Osteosarcoma| Rhabdomyosarcoma| Neuroblastoma|Ewing Sarcoma|Wilms Tumor| Adrenocortical Cancer| Desmoplastic Small Round Cell Tumor|Germ Cell Cancer|Rhabdoid Tumor|Clear Cell Sarcoma|Hepatoblastoma| Melanoma|Carcinoma|Malignant Peripheral Nerve Sheath Tumors|Soft Tissue Sarcoma |
Drug: Fludarabine Drug: Cyclophosphamide Drug: MESNA| Drug: B7-H3 CAR-T cells |
up to 21 Years (Child, Adult) | Phase 1 | St. Jude Children’s Research Hospital, Memphis, TN, United States |
| ClinicalTrials.gov Identifier: NCT04864821 |
Clinical Study of CD276 Targeted Autologous Chimeric Antigen Receptor T-Cell Infusion in Patients With CD276 Positive Advanced Solid Tumor |
Not yet recruiting |
No Results Available |
Osteosarcoma|Neuroblastoma| Gastric Cancer|Lung Cancer |
Drug: Targeting CD276 CAR-T cells | 1 Year to 70 Years (Child, Adult, Older Adult) |
Early Phase 1 |
PersonGen BioTherapeutics (Suzhou) Co., Ltd., The First Affiliated Hospital of Zhengzhou University |
| ClinicalTrials.gov Identifier: NCT04483778 |
B7H3 CAR-T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults |
Recruiting | No Results Available |
Pediatric Solid Tumor|Germ Cell Tumor|Retinoblastoma| Hepatoblastoma|Wilms Tumor|Rhabdoid Tumor| Carcinoma|Osteosarcoma| Ewing Sarcoma| Rhabdomyosarcoma| Synovial Sarcoma|Clear Cell Sarcoma|Malignant Peripheral Nerve Sheath Tumors|Desmoplastic Small Round Cell Tumor|Soft Tissue Sarcoma| Neuroblastoma|Melanoma |
Biological: second generation 4-1BBz B7H3-EGFRt-DHFR Biological: second generation 4-1BBz B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBz CD19-Her2tG |
0 Years to 26 Years (Child, Adult) | Phase 1 | Seattle Children’s Hospital, Seattle, WA, United States |
| ClinicalTrials.gov Identifier: NCT04432649 |
Targeting CD276 (B7-H3) Positive Solid Tumors by 4SCAR-276 | Recruiting | No Results Available |
Solid Tumor | Biological: 4SCAR-276 | 1 Year to 75 Years (Child, Adult, Older Adult) |
Phase 1| Phase 2 |
Shenzhen Children’s Hospital, Shenzhen Geno-immune Medical Institute, Sun Yat-Sen University, Shenzhen, Guangdong, China |
| ClinicalTrials.gov Identifier: NCT05731219 |
UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia |
Recruiting | No Results Available |
Relapsed/Refractory Acute Myeloid Leukemia | Biological: B7-H3 target, CAR gene-modified gdT cell injection | 18 Years and older (Adult, Older Adult) | Phase 1 | The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang, China |
| ClinicalTrials.gov Identifier: NCT05722171 |
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia | Recruiting | No Results Available |
Relapsed/Refractory Acute Myeloid Leukemia | Biological: gdT cell injection targeting B7-H3 chimeric antigen receptor |
18 Years and older (Adult, Older Adult) | Early Phase 1 | PersonGen Anke Cellular Therapeutics Co., Ltd. Hefei, Anhui, China |