NCT06372236

UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors

Completed Phase 1 Last updated 12 August 2025

What this trial tests

Phase 1 trial testing UTAA06 injection for treatment of advanced malignant solid tumors in Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor in 10 participants. Completed in 8 May 2025.

Timeline

5 December 2023

Primary endpoint
8 May 2025

8 May 2025

Quick facts

Lead sponsor	Peking University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	5 December 2023
Primary completion	8 May 2025
Estimated completion	8 May 2025
Sites	1 location across China

Drugs / interventions tested

• UTAA06 injection for treatment of advanced malignant solid tumors — full drug profile →

Conditions studied

• Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor — all drugs for Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor →

Sponsor

Peking University

Who can join

18 and older, any sex, with Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Beyond CAR-T Cells: exploring CAR-NK, CAR-M, and CAR-γδ T strategies in solid tumor immunotherapy.
   Hou Y, Hu S, Liu C, Chen X, et al · · 2025 · cited 6× · PMID 41181137 · DOI 10.3389/fimmu.2025.1675807
2. B7-H3 in Cancer Immunotherapy-Prospects and Challenges: A Review of the Literature.
   Mielcarska S, Kot A, Dawidowicz M, Kula A, et al · · 2025 · cited 5× · PMID 40801642 · DOI 10.3390/cells14151209
3. Re-Tooling of γδ T Cells for Cancer Immunotherapy Using Advanced Manufacturing and Genetic Engineering.
   Lim BJL, Maher J. · · 2026 · PMID 41892285 · DOI 10.3390/cells15060494
4. Allogeneic B7-H3-Targeted CAR Vδ1T-cell Therapy in Advanced Solid Tumors: A Phase I Study.
   Liu C, Li J, Liu D, Zhang P, et al · · 2026 · PMID 41779003 · DOI 10.1158/1078-0432.ccr-25-4600
5. Commentary on "Comparative efficacy and safety of PSCA CAR-engineered Vδ1 γδ T cells for immunotherapy of pancreatic cancer".
   de Bont DA, Straetemans T, Sebestyén Z, Kuball J. · · 2026 · PMID 41735001 · DOI 10.1136/jitc-2025-014199