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

Phase 1RecruitingNCT06730659

Tianjin Medical University Cancer Institute and Hospital36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed / Refractory Solid Tumor

Interventions

CHT101BIOLOGICAL

CHT101: CD 70 UCAR T

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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;

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Xin Yao, Ph.D

CONTACT

+86-02223340123 yaoxin1969@yahoo.com.cn

Data from ClinicalTrials.gov

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