A Clinical Trial of TAA06 Injection in Advanced Solid Tumors
1 other identifier
interventional
18
1 country
1
Brief Summary
B7-H3 (also known as CD276) is widely expressed on the surface of a variety of malignancies solid tumors, while it rarely or even doesn't express on normal tissues. Therefore, B7-H3 is an ideal target for chimeric antigen receptor (CAR) T cells therapy. TAA06 injection is a CAR T injection targeting B7-H3. This is a phase I clinical study with the primary objective of evaluating the safety and tolerability of TAA06 injection in subjects with TAA06-positive advanced solid tumors. The secondary objectives are as follows: to evaluate the distribution, proliferation and persistence of B7-H3-targeted CAR T cells after injection of TAA06 in subjects; to preliminarily evaluate the efficacy of TAA06 injection in subjects with TAA06-positive advanced solid tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 29, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJanuary 13, 2022
December 1, 2021
2.5 years
December 29, 2021
December 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of the safety after B7-H3 chimeric antigen receptor T cells infusion (Safety)
Incidence and treatment-relativity of adverse events assessed by NCI CTCAE v5.0.
3 months
Secondary Outcomes (5)
To evaluate anti-tumor activity (overall response rate)
6 months
To evaluate anti-tumor activity (disease control rate)
3 months
To evaluate anti-tumor activity (duration of response)
About 2 years
To evaluate anti-tumor activity (Progression Free Survival)
About 2 years
To evaluate anti-tumor activity (overall survival)
About 2 years
Study Arms (1)
TAA06 injection
EXPERIMENTALT cell injection targeting B7-H3 chimeric antigen receptor
Interventions
The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be treated with 1×106\~1×108 CAR-T/kg. And the subjects will be administered once.
Eligibility Criteria
You may qualify if:
- (1) Aged 18 to 70 years old (inclusive), male or female;
- (2) Expected survival time ≥ 12 weeks;
- (3) ECOG performance status of 0-1;
- (4) It is clearly diagnosed by pathology to be any of the following tumor types: malignant melanoma, lung cancer or colorectal cancer, and the positive rate of TAA06 expression in tumor tissues is ≥1% after immunohistochemical detection;
- (5) Subjects whose standard treatment methods are ineffective (eg: relapse after surgery, disease progress after treatment with chemotherapy, radiotherapy or targeted drugs);
- (6) According to the curative effect evaluation standard for solid tumors (RECIST 1.1), at least one measurable lesion (the longest diameter of the solid lesion ≥ 10mm, or the short diameter of the lymph node lesion ≥ 15mm);
- (7) The main organ function is normal (white blood cell count ≥3×109/L, neutrophil count ≥1.5×109/L, hemoglobin ≥8.5g/dL, platelet count ≥80×109/L, lymphocyte count at 1×109/L (inclusive) \~ 4×109/L (inclusive));
- (8) Liver and kidney function, heart and lung function meet the following criteria:
- Urea (Urea) and serum creatinine≤1.5×ULN;
- Left ventricular ejection fraction ≥50%;
- Baseline blood oxygen saturation ≥ 94%;
- Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN;
- (9) The subjects or his legal representative can fully understand the significance and risks of this trial and has signed informed consents.
You may not qualify if:
- (1) Subjects with a history of immunodeficiency or autoimmune diseases (including but not limited to rheumatoid joint disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); with graft-versus-host disease (GVHD) , Or those who need to use immunosuppressive agents;
- (2) Subjects with other type of malignant tumors within 5 years prior to screening;
- (3) Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test;
- (4) Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ III), severe arrhythmia;
- (5) Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
- (6) Within 7 days prior to screening, there are active or uncontrollable infections requiring systemic therapy (except for mild genitourinary infection and upper respiratory tract infection);
- (7) Pregnant or lactating women, and female subjects who plan to become pregnant within 1 year after cell infusion or male subjects whose partners plan to become pregnant within 1 year after cell infusion;
- (8) Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening;
- (9) Subjects who are receiving systemic steroid therapy within 7 days prior to screening or need long-term use of systemic steroid therapy during treatment as judged by the investigator (except for inhalation or topical use);
- (10) Subjects with more than a moderate amount of ascites, or after conservative medical treatment (such as diuresis, sodium restriction, excluding ascites drainage) for 2 weeks, the ascites still shows a progressive increase;
- (11) Conditions not eligible for cell preparation as judged by the investigator;
- (12) Other conditions considered unsuitable for enrollment by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PersonGen BioTherapeutics(Suzhou) Co., Ltd.
Suzhou, Jiangsu, 215125, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2021
First Posted
January 13, 2022
Study Start
June 1, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
January 13, 2022
Record last verified: 2021-12