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Recruiting NCT06730659

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

Phase I Interventional Relapsed / Refractory Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHT101.
Who it may be relevant to
Registry conditions: Relapsed / Refractory Solid Tumor. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological CHT101
    CHT101: CD 70 UCAR T

Primary outcome measures

  • Safety and Tolerability [Time frame: 2 years]
Secondary outcome measures (6)
  • Objective response rate (ORR) [Time frame: 28 days]
  • Disease control rate (DCR) [Time frame: 28 days]
  • Progress-free survival(PFS) [Time frame: 2 years]
  • Overall survival (OS ) [Time frame: 3 years]
  • pharmacokinetics (PK) [Time frame: 6 months]
  • Pharmacodynamics (PD) [Time frame: 6 months]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT06730659 · CHT101SIIT-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗