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| Name | Class |
|---|---|
| Nanjing Miracle Biotech Co. Ltd. | UNKNOWN |
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Recurrent or progressive primary malignant brain tumors are among the malignancies with a poor prognosis. They refer to primary brain tumors that either recur after standard treatment or show disease progression during the course of standard therapy. This group includes a variety of histological types, most commonly glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, and primary central nervous system lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHT 101 injection | Experimental | CHT101 is an allogeneic CD70-targeted chimeric antigen receptor T cell therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHT 101 | Biological | CHT101 is an allogeneic CD70-targeted chimeric antigen receptor Tcell therapy, intended to be administered locally for the treatment of primary malignant brain tumors. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 2 years | |
| Progress-free survival(PFS) | PFS will be assessed from CHT 101 infusion to death from any cause or the first assessment of progression | 2 years |
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Inclusion Criteria:
Subjects must be pathologically confirmed to have high-grade glioma, defined as WHO (2021) Central Nervous System Tumor Classification grade 3 or 4 gliomas; or primary central nervous system lymphoma (PCNSL).
Contrast-enhanced magnetic resonance imaging (MRI) must demonstrate the presence of an intracranial space-occupying lesion, with at least one measurable lesion.
At the time of signing the informed consent form (ICF), the Karnofsky Performance Status (KPS) score must be ≥70.
Exclusion Criteria:
History of bone marrow or solid organ transplantation. History of other primary malignancies within 5 years prior to study treatment. Prior receipt of CD70-targeted antitumor therapies, including but not limited to CD70-targeted cell therapies (autologous or allogeneic) and TCR-T therapy.
Prior treatment with CAR-T therapy or other cell/gene therapies. Presence of acute or moderate-to-severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to signing the informed consent form (ICF), or receipt of systemic therapy for GVHD within 4 weeks prior to the first infusion.
Clinically significant cardiovascular disease. Epilepsy that is difficult to control with medication, or chronic symptoms and signs of intracranial hypertension.
Inadequate bone marrow reserve or organ function. Pregnant or breastfeeding female subjects.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihui Hao, MD. PhD. | Contact | 8623-23340123 | haojihui@tjmuch.com | |
| Xiaoguang Wang, MD. PhD. | Contact | wangxiaoguang@tjmh.com |
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| Overall survival (OS ) | OS will be assessed from CHT 101 infusion to death | 2 years |
| pharmacokinetics (PK) | Concentration levels of CHT 101 | 2 years |
| Pharmacodynamics (PD) | Concentration levels of serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α | 2 years |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009369 | Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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