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NCT Number: NCT06730659

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

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

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Key information

Conditions

Relapsed / Refractory Solid Tumor Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location status: Recruiting

Location contact

Xin Yao, Ph.D

CONTACT

[email protected]

+86-02223340123

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to understand and sign a written informed consent documen；
  • At the date of signing ICF, 18 ~70 years old, male or female；
  • Histopathological confirmed advanced or metastatic solid tumors patients who have failed to standard treatment or intolerance with standard treatment；
  • Positive CD70 expression;
  • At least one measurable lesion at baseline per RECIST version 1.1；
  • The expected survival time is more than 12 weeks;
  • ECOG 0-1 points;
  • Adequate organ functions;

Treatment and study plan

CHT101

Biological

CHT101: CD 70 UCAR T

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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)

  5. pharmacokinetics (PK)

    Time frame: 6 months

    Concentration levels of CD70+ CAR-T cells

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Yao, Ph.D

CONTACT

[email protected]

+86-02223340123

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2039
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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