Refractory Solid Tumors, Relapsed Solid Tumors, TCR-T Cells
Conditions
Brief summary
1\) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.
Interventions
DRUGKSX01-TCRT injection
individualization TCR-T cell injection
Sponsors
TCRx Therapeutics 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
* 1\) Voluntary participation in clinical research; Fully understand the study and voluntarily sign an informed consent form; Willing to follow and capable of completing all test procedures. * 2\) Age: 18 to 70 years old (including boundary value). * 3\) Malignant solid tumors that have failed standard treatment or currently have no standard treatment available. * 4\) Patients with tumor lesions that can be punctured and can be screened for a pharmaceutically acceptable TCR sequence can be enrolled in the study. * 5\) Remission from previous surgical or treatment related adverse events to a level of 0-1, stable, or acceptable for inclusion/
Exclusion criteria
(according to NCI CTCAE Version 5.0), or to an acceptable level for inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject safety | about 2 years | Number of participants with treatment-related adverse events assessed by CTCAE v4.0. |
| tumor efficacy | about 2 years | Changes in overall tumor diameter. |
Countries
China
Contacts
Primary Contactclinical trials ksh
Outcome results
None listed