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（CROWN）

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain (Nervous System) Cancers
• Intervention / Treatment: Biological: CHT 101

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jihui Hao, MD. PhD.; Phone Number: 8623-23340123; Email: haojihui@tjmuch.com
• Study Contact Backup: Name: Xiaoguang Wang, MD. PhD.; Email: wangxiaoguang@tjmh.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHT 101 injection; CHT101 is an allogeneic CD70-targeted chimeric antigen receptor T cell therapy.	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Nanjing Miracle Biotech Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Primary Malignant Brain Tumors
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Neurologic Manifestations; Brain Neoplasms
• Other Study ID Numbers: CHT101SIIT-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No