A Clinical Study of CHT101 in CD70-Positive Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Relapsed / Refractory Solid Tumor
• Interventions: Biological: CHT101

• Registration Number: NCT06730659
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Study Start: 2024-04-19
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2027-04-18
• Study Completion: 2039-04-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHT101 infusion	CHT101	CHT 101 will be dosing by IV.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, China