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

Tianjin Medical University

Status and phase: Enrolling; Phase 1

Conditions: Relapsed / Refractory Solid Tumor

Treatments: Biological: CHT101

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06730659

CHT101SIIT-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and 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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

36 participants in 1 patient group

CHT101 infusion

Experimental group

Description:

CHT 101 will be dosing by IV.

Treatment:

Biological: CHT101