A Phase I, Single-arm, Open-label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Pr… (NCT07496073) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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)
30 participantsStarted 2026-03-20
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability
Timeframe: 2 years
Trial details
NCT IDNCT07496073
SponsorTianjin Medical University Cancer Institute and Hospital