A Phase 1 interventional study of CHT101 in Relapsed / Refractory Solid Tumor, sponsored by Tianjin Medical University Cancer Institute and Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 1, Interventional, and Treatment
Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.
4 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 36 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
CHT 101 will be dosing by IV.
Biological: CHT101
CHT101: CD 70 UCAR T
Safety and Tolerability
Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time frame: 2 years
Objective response rate (ORR)
The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Time frame: 28 days
Disease control rate (DCR)
The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Time frame: 28 days
Progress-free survival(PFS)
PFS will be assessed from the first CD70 UCAR-T cell infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)
Time frame: 2 years
Overall survival (OS )
OS will be assessed from the first CD70 UCAR-T cell infusion to death from any cause (Assessed based on RECIST criteria)
Time frame: 3 years
pharmacokinetics (PK)
Concentration levels of CD70+ CAR-T cells
Time frame: 6 months
Pharmacodynamics (PD)
Concentration levels of CD70 U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α
Time frame: 6 months
Plan to share: No
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Tianjin Medical University Cancer Institute and Hospital