Relapsed / Refractory Solid Tumor
Conditions
Keywords
Allogeneic CAR-T, Safety, Efficacy, PK
Brief summary
Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.
Detailed description
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.
Interventions
BIOLOGICALCHT101
CHT101: CD 70 UCAR T
Sponsors
Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NON_RANDOMIZED
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. Ability to understand and sign a written informed consent documen； 2. At the date of signing ICF, 18 \ 70 years old, male or female； 3. Histopathological confirmed advanced or metastatic solid tumors patients who have failed to standard treatment or intolerance with standard treatment； 4. Positive CD70 expression; 5. At least one measurable lesion at baseline per RECIST version 1.1； 6. The expected survival time is more than 12 weeks; 7. ECOG 0-1 points; 8. Adequate organ functions;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 2 years | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 28 days | 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. |
| Disease control rate (DCR) | 28 days | 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. |
| Progress-free survival(PFS) | 2 years | 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) |
| Overall survival (OS ) | 3 years | OS will be assessed from the first CD70 UCAR-T cell infusion to death from any cause (Assessed based on RECIST criteria) |
| pharmacokinetics (PK) | 6 months | Concentration levels of CD70+ CAR-T cells |
| Pharmacodynamics (PD) | 6 months | Concentration levels of CD70 U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α |
Countries
China
Contacts
Primary ContactXin Yao, Ph.D
Outcome results
None listed