Brain (Nervous System) Cancers
Conditions
Keywords
Primary Malignant Brain Tumors
Brief summary
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.
Interventions
BIOLOGICALCHT 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.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Nanjing Miracle Biotech Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 2 years | Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 2 years | — |
| Progress-free survival(PFS) | 2 years | PFS will be assessed from CHT 101 infusion to death from any cause or the first assessment of progression |
| Overall survival (OS ) | 2 years | OS will be assessed from CHT 101 infusion to death |
| pharmacokinetics (PK) | 2 years | Concentration levels of CHT 101 |
| Pharmacodynamics (PD) | 2 years | Concentration levels of serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α |
Contacts
CONTACTJihui Hao, MD. PhD.
CONTACTXiaoguang Wang, MD. PhD.
Outcome results
None listed