NCT05143151

UnknownPhase 1/2

CD276-targeted Chimeric Antigen Receptor T Cells in Treatmen...

Shenzhen University General Hospital Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

HEM-ONCO-013

Study Type

interventional

Estimated enrollment

10

Locations

1 country

Sites

1

Timeline

Study Start

July 1, 2021

Actual (reported)

Primary Completion

June 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

July 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

CD276 (B7-H3) is a member of the B7 costimulatory molecule family. Its mRNA is widely expressed in tissues, but the protein expression is limited. It is expressed in resting fibroblasts, endothelial cells, osteoblasts, amniotic fluid stem cells and other non-immune cells, and The surface of induced antigen-presenting cells and NK cells. Many studies have revealed that B7-H3 is overexpressed in a variety of tumors, including melanoma, pancreatic cancer, breast cancer, prostate cancer, colorectal cancer and other tumors, and its expression level is closely related to the poor prognosis and clinical outcome of patients . Preclinical studies have confirmed that the expression of CD276 mRNA in pancreatic cancer tissues is significantly higher than that of normal adjacent groups.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 10 participants
Study completion date: July 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 1, 2021
Actual (reported)
First Submitted
November 22, 2021
Actual (reported)
First Posted
December 3, 2021
Actual (reported)
Primary Completion
June 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: December 3, 2021
Status Verified: July 2021
Last Update Submitted: December 2, 2021

Conditions

Advanced Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

Objective response rate (ORR)
up to 1 year

Secondary Outcomes (1)

Overall survival rate (OS)
From admission to the end of follow up, up to 2 years.

Study Arms (1)

Treatment group

EXPERIMENTAL

CD276 targeted chimeric antigen receptor cells treatment

Biological: CD276 CAR-T cells

Interventions

CD276 CAR-T cellsBiological

CD276 CAR-T cells infusion

Treatment group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18-75 years old (≥18 years old, ≤75 years old), no gender limit;
The subject voluntarily participates in the study, and he or his legal guardian signs the "Informed Consent";

Sponsors & Collaborators

Shenzhen University General Hospital
Otherlead

Study Sites (1)

Li Yu

Shenzhen, Guangdong, 518000, China

RECRUITING

Li YuCONTACT+8675521839178 liyu_gcp@163.com

Study Officials

Li Yu, Dr
Shenzhen University General Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yu

CONTACT

+8675521839178 liyu@vip.163.com

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 3, 2021

Study Start

July 1, 2021

Actual (reported)

Primary Completion

June 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

NCT05526443

Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Recruiting

Unresectable, locally advanced recurrence or metastatic pancreatic cancer diagnosed by histopathological examination; according to the American Joint Committee on Cancer (AJCC) TNM staging system (2017 version 8), diagnosed as stage III or IV pancreatic cancer ；

According to the RECIST 1.1 standard, there are clear measurable and evaluable lesions;

The tumor tissue was confirmed by immunohistochemical staining, and CD276 expression was positive;

The subject must have received first-line treatment;

The subject must be unsuitable for radical treatment, such as radical chemotherapy and/or surgery/immune checkpoint inhibitors, or refuse surgical resection

Within 2 weeks before cell therapy, have not received antibody drug treatment;

The ECOG score is 0-2 points;

The subject has no contraindications for peripheral blood apheresis;

The expected survival time is more than 3 months

You may not qualify if:

Those who have a history of allergies to any of the ingredients in cell products;
Routine blood examinations have the following conditions: WBC≦1×109/L, absolute centrioles ANC≦0.5×109/L, absolute lymphocyte value ALC≦0.5×109/L, PLT≦25×109/L;
The following conditions in laboratory tests include, but are not limited to, serum total bilirubin ≥ 1.5 mg/dl; serum ALT or AST greater than 2.5 times the upper limit of normal; blood creatinine ≥ 2.0 mg/dl;
According to the New York Heart Association (NYHA) cardiac function classification standards, patients with grade III or IV cardiac insufficiency; or echocardiographic examination of left ventricular ejection fraction (LVEF) \<50%;
Abnormal lung function, blood oxygen saturation in indoor air \<92%;
Myocardial infarction, cardiovascular angioplasty or stenting, unstable angina pectoris, or other serious clinical heart diseases within 12 months before enrollment;
High blood pressure level 3 and poor blood pressure control with medication;
Previously suffering from head injury, disturbance of consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
Patients with autoimmune diseases, immunodeficiencies, or other patients who need immunosuppressive therapy;
There is an uncontrolled active infection;
Have used any CAR-T cell products or other genetically modified T cell therapies before;
Live vaccination within 4 weeks before enrollment;
HIV, HBV, HCV and TPPA/RPR infected persons, and HBV carriers;
The subject has a history of alcoholism, drug abuse or mental illness;
The subject has participated in any other clinical research within 3 months before joining this clinical research;
+2 more criteria

Contact the study team to confirm eligibility.

Study Completion

July 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

December 3, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05143151
Data provider: ClinicalTrials.gov
Source updated: 2021-12-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:01 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Treatment group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations