Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid TumorPhase 1NCT06372236
UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors
A Phase 1 study testing UTAA06 injection for treatment of advanced malignant solid tumors in people with Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor, run by Peking University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor
- What is being tested?
- UTAA06 injection for treatment of advanced malignant solid tumors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 8 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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;
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- (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.
Who cannot join
- (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;
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- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study of UTAA06 Injection in Treatment of Patients With Advanced Malignant Solid Tumors
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.
Read the detailed 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. This research mainly adopts RECISTv1.1 tumor assessment, in addition to the baseline period, treatment period after the cell infusion, 2 m, 3 m, 4 w during 6 to 24 m in the frequency of Q3m curative effect evaluation of tumor assessment until disease progression (PD, Other than spurious progression), new anti-tumor therapy, death, intolerable toxicity, investigator decision, or patient voluntary withdrawal, whichever occurs first.
In this study phase, the recommended dose is 1×10^8~1×10^9CAR+gdT (including 1×10^8CAR+gdT, 3×10^8CAR+gdT, 5×10^8CAR+gdT, 8×10^8CAR+gdT, 1×10^9CAR+gdT), or as determined by the investigator and/or partner unit. Other doses can be added. Each subject in the same dose group can receive the infusion of the next subject after 14 days of observation, and the last subject in each dose group can be observed for 28 days after infusion, and the researcher will determine whether the treatment can be incremented into the next dose group based on safety detection indicators. A total of 15 to 24 patients with advanced malignant solid tumors were enrolled.
B7-H3 is a pan-tumor antigen that is overexpressed on a variety of solid tumors. This study is a B7-H3 targeted therapy, and it is planned to conduct a pan-tumor study without targeting specific tumor species, and does not consider classification and dose allocation according to tumor species.
- Being tested
- UTAA06 injection for treatment of advanced malignant solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UTAA06 injection for treatment of advanced malignant solid tumorsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted B7-H3 chimeric antigen receptor gdT cell injection | Experimental | UTAA06 injection 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. Receives: Biological: UTAA06 injection for treatment of advanced malignant solid tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Maximum tolerated dose
Measured: about 2 years
To evaluate the preliminary antitumor activity of UTAA06 injection in patients with advanced malignant solid tumors
Overall response rate (ORR) at 3 months (based primarily on solid tumor response criteria RECISTv1.1).
Measured: about 2 years
To evaluate the number of participants with treatment-related adverse events of UTAA06 injection in patients with advanced malignant solidtumors.
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0
Measured: about 2 years
Secondary outcomes (7)
To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors.
Overall survival (OS)
Measured: about 2 years
To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors.
duration of response (DOR)
Measured: about 2 years
To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors.
progression-free survival (PFS)
Measured: about 2 years
To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors.
disease control rate (DCR)
Measured: about 2 years
To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors.
The maximum concentration of UTAA06 cells in peripheral blood after administration (Cmax)
Measured: about 2 years
To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors.
the time to reach the maximum concentration (Tmax)
Measured: about 2 years
To evaluate the immunogenicity of UTAA06 injection in patients with advanced malignant solid tumors.
The positive rate of human anti-CAR antibody at each time point.
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start5 Dec 2023
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- UTAA06 injection
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372236
- Sponsor's protocol ID
- PG-001-025
- Status last verified
- May 2025
- First submitted
- 14 Dec 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of UTAA06 Injection in Treatment of Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06372236
- Acronym / sponsor ID
- PG-001-025
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. This research mainly adopts RECISTv1.1 tumor assessment, in addition to the baseline period, treatment period after the cell infusion, 2 m, 3 m, 4 w during 6 to 24 m in the frequency of Q3m curative effect evaluation of tumor assessment until disease progression (PD, Other than spurious progression), new anti-tumor therapy, death, intolerable toxicity, investigator decision, or patient voluntary withdrawal, whichever occurs first.
In this study phase, the recommended dose is 1×10^8~1×10^9CAR+gdT (including 1×10^8CAR+gdT, 3×10^8CAR+gdT, 5×10^8CAR+gdT, 8×10^8CAR+gdT, 1×10^9CAR+gdT), or as determined by the investigator and/or partner unit. Other doses can be added. Each subject in the same dose group can receive the infusion of the next subject after 14 days of observation, and the last subject in each dose group can be observed for 28 days after infusion, and the researcher will determine whether the treatment can be incremented into the next dose group based on safety detection indicators. A total of 15 to 24 patients with advanced malignant solid tumors were enrolled.
B7-H3 is a pan-tumor antigen that is overexpressed on a variety of solid tumors. This study is a B7-H3 targeted therapy, and it is planned to conduct a pan-tumor study without targeting specific tumor species, and does not consider classification and dose allocation according to tumor species.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- UTAA06 injection
| Arm | Type | Receives |
|---|---|---|
| Targeted B7-H3 chimeric antigen receptor gdT cell injection | Experimental | Biological: UTAA06 injection for treatment of advanced malignant solid tumorsUTAA06 injection 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- (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%;
Key exclusion criteria (15 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UTAA06 injection for treatment of advanced malignant solid tumorsThe 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. | Biological | Targeted B7-H3 chimeric antigen receptor gdT cell injection |
Primary outcome
MTD
Time frame: about 2 years
Maximum tolerated dose
To evaluate the preliminary antitumor activity of UTAA06 injection in patients with advanced malignant solid tumors
Time frame: about 2 years
Overall response rate (ORR) at 3 months (based primarily on solid tumor response criteria RECISTv1.1).
To evaluate the number of participants with treatment-related adverse events of UTAA06 injection in patients with advanced malignant solidtumors.
Time frame: about 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0
7 secondary outcomes
To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors.
Time frame: about 2 years
To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors.
Time frame: about 2 years
To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors.
Time frame: about 2 years
To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors.
Time frame: about 2 years
To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors.
Time frame: about 2 years
To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors.
Time frame: about 2 years
To evaluate the immunogenicity of UTAA06 injection in patients with advanced malignant solid tumors.
Time frame: about 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UTAA06 injection for treatment of advanced malignant solid tumors in people with Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: about 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.