CD276 CAR-T for Patients With Advanced CD276+ Solid Tumors

PersonGen BioTherapeutics

Status

Unknown

Conditions

Solid Tumor

CAR

Treatments

Drug: Targeting CD276 autologous chimeric antigen receptor T cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT04691713

PG-CART-276-001

Details and patient eligibility

About

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.

Enrollment

5 estimated patients

Sex

All

Ages

3 to 70 years old

Volunteers

No Healthy Volunteers

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