Clinical trial NCT05190185: A Clinical Trial of TAA06 Injection in Advanced Solid Tumors
Official title: A Clinical Trial of TAA06 Injection in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Malignant Melanoma, Lung Cancer, or Colorectal Cancer
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Hebei Medical University Fourth Hospital
First posted: 2022-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* (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:

  1. Urea (Urea) and serum creatinine≤1.5×ULN;
  2. Left ventricular ejection fraction ≥50%;
  3. Baseline blood oxygen saturation ≥ 94%;
  4. 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 Criteria:

* (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.

Primary outcomes:
measure: Assessment of the safety after B7-H3 chimeric antigen receptor T cells infusion (Safety)
timeFrame: 3 months
Secondary outcomes:
measure: To evaluate anti-tumor activity (overall response rate)
timeFrame: 6 months
measure: To evaluate anti-tumor activity (disease control rate)
timeFrame: 3 months
measure: To evaluate anti-tumor activity (duration of response)
timeFrame: About 2 years
measure: To evaluate anti-tumor activity (Progression Free Survival)
timeFrame: About 2 years
measure: To evaluate anti-tumor activity (overall survival)
timeFrame: About 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: PersonGen BioTherapeutics(Suzhou) Co., Ltd.
state: Jiangsu
Study officials:
References: