Clinical trial NCT04691713: CD276 CAR-T for Patients With Advanced CD276+ Solid Tumors
Official title: CD276 CAR-T for Patients With Advanced CD276+ Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CAR
Solid Tumor
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-31
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a clinical study of CD276 CAR-T in the treatment of patients with advanced solid tumors. The purpose is to evaluate the safety and effectiveness of targeting CD276 auto-chimeric antigen receptor T cells in the treatment of CD276-positive advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Age 3-70
* Expected survival time ≥ 12weeks
* ECOG 0-2
* At least second-line or above chemotherapy failed
* According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), at least one measurable lesion (non-nodular lesion with longest diameter ≥10mm, or nodular lesion with short diameter ≥15mm)
* Liver and kidney function, heart and lung function meet the following requirements:

  1. Creatinine is within the normal range;
  2. Left ventricular ejection fraction ≥ 45%;
  3. Baseline blood oxygen saturation\>91%;
  4. Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN
* Understand the trial and have signed the informed consent

Exclusion Criteria:

* Those who have graft-versus-host disease (GVHD) or need to use immunosuppressive agents
* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer test is not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) Antibody positive; CMV DNA test positive; Syphilis test positive
* Severe heart disease
* Systemic diseases judged by the investigator to be unstable: including but not limited to severe liver, kidney or metabolic diseases that require medication
* Within 7 days before screening, there are active infections or uncontrollable infections that require systemic treatment (except for mild urogenital infections and upper respiratory tract infections)
* Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 1 year after cell reinfusion, or male subjects whose partners plan to become pregnant within 1 year after cell reinfusion
* Those who have received CAR-T therapy or other genetically modified cell therapy before screening
* Subjects who are receiving systemic steroid therapy at the time of screening and the investigator determines that they need long-term systemic steroid therapy during the treatment period (except for inhaled or topical use)
* Participated in other clinical studies within 3 months before screening
* Central nervous system metastases are known to occur and for suspected central nervous system metastases, head MRI examination is required to rule out
* Patients with partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved by active treatment
* 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
* According to the researcher's judgment, it does not meet the situation of cell preparation
* Situations that other researchers think are not suitable for inclusion

Primary outcomes:
measure: ORR 3
timeFrame: Three months after CAR T cell infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Bin Hu Hospital
state: Anhui
Study officials:
References: