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)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Tumor tissue specimens must be CD70-positive as determined by immunohistochemistry (IHC).

Disqualifiers

Patients with brainstem recurrence, spinal dissemination, or extracranial metastasis.

Trial design

Design model

Single group

Treatments tested in this trial

  • CHT 101

    Biological/Vaccine

    CHT101 is an allogeneic CD70-targeted chimeric antigen receptor Tcell therapy, intended to be administered locally for the treatment of primary malignant brain tumors.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CHT 101 injectionExperimental treatment 1 intervention

Trial outcomes

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

Time frame
2 years

Secondary outcomes

1

Objective response rate (ORR)

Time frame
2 years
2

Progress-free survival(PFS)

PFS will be assessed from CHT 101 infusion to death from any cause or the first assessment of progression

Time frame
2 years
3

Overall survival (OS )

OS will be assessed from CHT 101 infusion to death

Time frame
2 years
4

pharmacokinetics (PK)

Concentration levels of CHT 101

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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