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

December 10, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

A Single-Arm, Open-Label, Phase I Study of CHT101 for CD70-Positive Relapsed/Refractory Solid Tumors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHT101 infusion
CHT 101 will be dosing by IV.
Biological: CHT101
CHT101: CD 70 UCAR T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 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)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 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.
28 days
Disease control rate (DCR)
Time Frame: 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.
28 days
Progress-free survival(PFS)
Time Frame: 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)
2 years
Overall survival (OS )
Time Frame: 3 years
OS will be assessed from the first CD70 UCAR-T cell infusion to death from any cause (Assessed based on RECIST criteria)
3 years
pharmacokinetics (PK)
Time Frame: 6 months
Concentration levels of CD70+ CAR-T cells
6 months
Pharmacodynamics (PD)
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2024

Primary Completion (Estimated)

April 18, 2027

Study Completion (Estimated)

April 18, 2039

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Estimated)

December 12, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHT101SIIT-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsed / Refractory Solid Tumor

Clinical Trials on CHT101

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe