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

Not Applicable

• Conditions: CAR; Solid Tumor
• Interventions: Drug: Targeting CD276 autologous chimeric antigen receptor T cells

• Registration Number: NCT04691713
• Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-28
• Last Update Submitted: 2020-12-28
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31
• Primary Completion: 2021-02-26
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Targeting CD276 autologous chimeric antigen receptor T cells	Targeting CD276 autologous chimeric antigen receptor T cells	-

Primary Outcome Measures

Name	Time	Method
ORR 3	Three months after CAR T cell infusion	3-month objective response rate

Trial Locations

Locations (1)

Bin Hu Hospital; 🇨🇳 Hefei, Anhui, China