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）

NCT07496073 | Not Yet Recruiting Phase 1

• 1 other identifier: CHT101SIIT-03
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain (Nervous System) Cancers

Keywords

Primary Malignant Brain Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective response rate (ORR)

  2 years

• Progress-free survival(PFS)

  2 years

• Overall survival (OS )

  2 years

• pharmacokinetics (PK)

  2 years

• Pharmacodynamics (PD)

  2 years

Study Arms (1)

CHT 101 injection

EXPERIMENTAL

CHT101 is an allogeneic CD70-targeted chimeric antigen receptor T cell therapy.

Biological: CHT 101

Interventions

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.

CHT 101 injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Nanjing Miracle Biotech Co. Ltd.: collaborator

MeSH Terms

Conditions

Neurologic Manifestations; Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Jihui Hao, MD. PhD.

CONTACT

8623-23340123; haojihui@tjmuch.com

Xiaoguang Wang, MD. PhD.

CONTACT

wangxiaoguang@tjmh.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share