Trial Title:
UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors
NCT ID:
NCT06372236
Condition:
Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
UTAA06 injection
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
UTAA06 injection for treatment of advanced malignant solid tumors
Description:
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.
Arm group label:
Targeted B7-H3 chimeric antigen receptor gdT cell injection
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
PersonGen Anke Cellular Therapeutice Co.,Ltd
Address:
City:
Hefei
Zip:
230088
Country:
China
Status:
Recruiting
Contact:
Last name:
Huimin Meng, Doctor
Phone:
+86-18015580390
Email:
huimin.meng@persongen.com
Start date:
December 1, 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06372236
