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

NCT ID: NCT06730659

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-19

Study Completion Date

2039-04-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsed / Refractory Solid Tumor

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Allogeneic CAR-T Safety Efficacy PK

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CHT101 infusion

CHT 101 will be dosing by IV.

Group Type EXPERIMENTAL

CHT101

Intervention Type BIOLOGICAL

CHT101: CD 70 UCAR T

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CHT101

CHT101: CD 70 UCAR T

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xin Yao, Ph.D

Role: CONTACT

Phone: +86-02223340123

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xin Yao, Ph.D

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHT101SIIT-05

Identifier Type: -

Identifier Source: org_study_id