UTAA06 injection for advanced malignant solid tumors

Phase I Clinical Study of UTAA06 Injection in Treatment of Patients With Advanced Malignant Solid Tumors

This study is testing a new injection called UTAA06 to see if it can safely help people with advanced solid tumors that have a specific marker called B7-H3.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University (other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06372236 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label clinical study aimed at determining the maximum tolerated dose and optimal dosing for the UTAA06 injection in patients with advanced malignant solid tumors that express the B7-H3 marker. Participants will receive the injection after a pretreatment phase, and their blood will be collected to assess safety, immunogenicity, and pharmacokinetics. Tumor response will be evaluated using RECIST criteria at various intervals up to 24 months, monitoring for disease progression or other endpoints. The study focuses on understanding the drug's initial anti-tumor activity and other characteristics.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced malignant solid tumors expressing B7-H3 and who have failed previous treatments.

Not a fit: Patients with tumors that do not express B7-H3 or those who have not failed conventional treatments 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 malignant solid tumors that are resistant to conventional therapies.

How similar studies have performed: While this approach is novel in targeting B7-H3, similar studies targeting other tumor markers have shown promising results.

Eligibility criteria

Inclusion Criteria:

* (1) Age ≥18 years old (including the threshold value), gender is not limited;
* (2) Expected survival time ≥3 months;
* (3) ECOG score 0\~2 points;
* (4) Subjects who meet the clinical diagnostic criteria and are clearly diagnosed as malignant solid tumor by pathology and failed by conventional treatment;
* (5) immunohistochemistry (IHC) staining of tumor tissue samples showed that B7-H3 on tumor cell membrane surface was 1+ or above; while immunohistochemistry (IHC) staining of tumor cell membrane was ≥50%;
* (6) The presence of at least one measurable lesion according to RECIST version 1.1;
* (7) Blood cell analysis (no transfusion treatment within 3 days) : Hemoglobin (Hb) ≥80g/L; Absolute neutrophil count ≥1.5 x 10\^9/L; Platelet count (PLT) ≥75×10\^9/L;
* (8) Kidney, liver, heart and lung function meet the following requirements: Creatinine clearance ≥60 ml/min or serum creatinine ≤ 1.5× upper limit of normal (ULN); Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤1.5 x ULN, Total bilirubin (TBL) ≤1.5×ULN (If the elevation of ALT and AST can be reasonably attributed to the presence of metastatic lesions in the liver, AST and ALT can be increased to 5×ULN, TBL can be increased to 3×ULN; Serum albumin ≥3.0g/dL; No clinically significant Electrocardiogram (ECG) results with left ventricular ejection fraction ≥ 50%; Blood oxygen saturation \> 95% in the non-oxygenated state;
* (9) The patient himself/herself and/or his/her guardian and/or impartial witnesses can understand the test and have signed the informed consent.

Exclusion Criteria:

* (1) Patients with continuous use of immunosuppressants within 1 month before infusion of UTAA06 injection;
* (2) cerebrovascular accident or convulsive attack occurred within 6 months before signing the informed consent;
* (3) Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) DNA titer detected by peripheral blood is not within the normal reference value range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) antibody positive; EBV DNA test positive; cytomegalovirus (CMV) DNA test positive; Syphilis positive;
* (4) Serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;
* (5) Other unstable systemic diseases as determined by the researcher;
* (6) had other uncured malignant tumors within the past 5 years or at the same time, except for in situ cervical cancer, skin basal cell carcinoma and other in situ cancers;
* (7) Chronic progressive nervous system disease;
* (8) Patients who have not yet recovered from the acute toxic effects of prior treatment (hematological or organ toxicity \> Grade 2 caused by prior treatment, except those related to the studied disease and medical history);
* (9) Previous or current graft-versus-host disease (GVHD);
* (10) There is an active or uncontrolled infection that requires systemic treatment (except for mild genitourinary and upper respiratory tract infections);
* (11) Female subjects who are capable of becoming pregnant and plan to become pregnant within 2 years after the cell infusion; Or a male subject whose partner plans to become pregnant within 2 years of the cell infusion;
* (12) Participating in clinical studies of other innovative drugs within 1 month before screening;
* (13) Evidence of central nervous system invasion during subject screening;
* (14) For patients with liver metastases, the researchers judged that the tumor load of liver metastases was too large to be eligible for inclusion in this clinical trial.
* (15) Situations considered unsuitable for inclusion by other researchers.

Where this trial is running

Hefei, Anhui

• PersonGen Anke Cellular Therapeutice Co.,Ltd — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Lin Shen, doctor

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