MedTrace Logo

UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors

NCT06372236 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-12

No results posted yet for this study

Summary

This is a single-arm, open, early-stage clinical study. The main purpose of this study is to explore the maximum tolerated dose (MTD), the optimal phase II recommended dose, safety, initial anti-tumor activity, cytopharmacokinetics, immunogenicity, biomarkers and other characteristics of drug therapy in patients with advanced malignant solid tumors. Eligible subjects were transfused with UTAA06 injection after pretreatment, and their blood was collected before and after infusion for evaluation of cytopharmacokinetics, safety, immunogenicity and biomarkers. In this study, tumor evaluation was mainly performed using RECISTv1.1. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of Q3m during 4w, 2m, 3m, and 6-24m after cell infusion. Tumor evaluation was performed until disease progression (PD), new anti-tumor therapy, death, intolerable toxicity, investigator's decision, or patient's voluntary withdrawal. Whichever comes first.

Conditions

  • Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor

Interventions

BIOLOGICAL

UTAA06 injection for treatment of advanced malignant solid tumors

The subjects who sign the informed consent forms and been screened by inclusion/exclusion criteria,will be assigned into 1×10\^8CAR+gdT、3×10\^8CAR+gdT、5×10\^8CAR+gdT、8×10\^8CAR+gdT、1×10\^9CAR+gdT groups inder of sequence.And the subjects will be administered once.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2025-05-08
Completion
2025-05-08

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06372236 on ClinicalTrials.gov