RecruitingPhase 1NCT05562024

TAA06 Injection in the Treatment of Patients With B7-H3-positive Relapsed/ Refractory Neuroblastoma

An Open-label, Dose-escalation, and Dose-expansion Phase I Trial of TAA06 Injection in Patients With Relapsed/Refractory Neuroblastoma


Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Enrollment

24 participants

Start Date

Dec 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Phase I clinical trials are designed as open-label, dose-escalation and dose-expansion clinical studies, the main purpose of which is to explore the tolerability, safety, cytokinetic characteristics and RP2D and preliminary observation of the efficacy of the study drug in subjects with B7-H3-positive relapsed/refractory neuroblastoma.


Eligibility

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This trial is testing a new cancer-fighting injection called TAA06 for children and young people with neuroblastoma — a cancer of the nervous system — that has come back or stopped responding to previous treatment. TAA06 is designed to target a protein called B7-H3, which is found on the surface of neuroblastoma cancer cells. **You may be eligible if...** - You are at least 1 year old - You have been diagnosed with relapsed or refractory neuroblastoma (cancer that returned or didn't respond to standard treatment) - Your cancer cells test positive for the B7-H3 protein - You have at least one measurable tumor site - Your heart, liver, and kidney function are within acceptable ranges - Your overall health status (performance score) meets study requirements - You are expected to survive at least 3 months **You may NOT be eligible if...** - You require long-term immune-suppressing medications - Your organ function does not meet the study's minimum requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALT cell injection targeting B7-H3 chimeric antigen receptor

The subjects will be administered once.


Locations(2)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

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NCT05562024