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

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.

Study Overview

• Status: Unknown
• Conditions: Solid Tumor; CAR
• Intervention / Treatment: Drug: Targeting CD276 autologous chimeric antigen receptor T cells

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Recruiting
      • Bin Hu Hospital
      • Contact: yangyi bao; Phone Number: 186-5516-8357; Email: 761760565@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Targeting CD276 autologous chimeric antigen receptor T cells

Drug: Targeting CD276 autologous chimeric antigen receptor T cells; Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR 3	3-month objective response rate	Three months after CAR T cell infusion

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): February 26, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PG-CART-276-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No