Treatment of advanced solid tumors using CD70-targeting CAR-T cells
A Single-Arm, Open-Label, Phase I Study of CHT101 for CD70-Positive Relapsed/Refractory Solid Tumors
This study is testing a new CAR-T cell therapy that targets a specific protein in advanced solid tumors to see if it can help patients with these cancers feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06730659 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and efficacy of CHT101, an allogeneic CAR-T cell therapy targeting CD70, in patients with advanced solid tumors that express CD70. The study consists of a dose escalation phase with four planned cohorts, followed by a dose expansion phase after a safety review. Participants will be monitored for safety, pharmacokinetics, and preliminary efficacy data throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with CD70-positive advanced or metastatic solid tumors who have failed or are intolerant to standard treatments.
Not a fit: Patients with tumors that do not express CD70 or those who have not failed standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to standard treatments.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results, indicating potential success for this novel approach targeting CD70.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Tianjin
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Xin Yao, Ph.D
- Email: yaoxin1969@yahoo.com.cn
- Phone: +86-02223340123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.