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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

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