Status:
UNKNOWN
A Clinical Trial of TAA06 Injection in Advanced Solid Tumors
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborating Sponsors:
Hebei Medical University Fourth Hospital
Conditions:
Malignant Melanoma, Lung Cancer, or Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- (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.
Exclusion
- (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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05190185
Start Date
June 1 2021
End Date
December 1 2023
Last Update
January 13 2022
Active Locations (1)
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1
PersonGen BioTherapeutics(Suzhou) Co., Ltd.
Suzhou, Jiangsu, China, 215125