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Université de médecine de TianjinA Phase I, Single-arm, Open-label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of CHT101 Cell Infusion in Adult Subjects With Recurrent or Progressive Malignant Primary Brain Tumors（CROWN） Phase I 30 Ouvert
A Phase I, Single-arm, Open-label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of CHT101 Cell Infusion in Adult Subjects With Recurrent or Progressive Malignant Primary Brain Tumors
- CHT101SIIT-03
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalCHT 101 injection CHT101 is an allogeneic CD70-targeted chimeric antigen receptor T cell therapy. | CHT 101 CHT101 is an allogeneic CD70-targeted chimeric antigen receptor Tcell therapy, intended to be administered locally for the treatment of primary malignant brain tumors. |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
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 |
- Tumor tissue specimens must be CD70-positive as determined by immunohistochemistry (IHC).
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.
- Patients with brainstem recurrence, spinal dissemination, or extracranial metastasis.
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.
Université de médecine de Tianjin378 essais cliniques actifs à explorerNanjing Miracle Biotech Co. Ltd.