RecruitingPhase 1NCT06500819

Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors

Phase I Clinical Trial of Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Children and Young Adults With Relapsed or Refractory Solid Tumor Expressing B7-H3 Target


Sponsor

Crystal Mackall, MD

Enrollment

41 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test the manufacturing feasibility and safety of intravenous (IV) administration of B7-H3CART in children and young adult subjects with relapsed and/or refractory solid tumors expressing B7-H3 target using a standard 3+3 dose escalation design.


Eligibility

Min Age: 2 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of cancer immunotherapy called B7-H3 CAR-T cell therapy — where a patient's own immune cells are genetically modified to find and attack solid tumors — in children and young adults with relapsed or treatment-resistant solid tumors. **You may be eligible if...** - You are between 2 and 30 years old (the first three patients must be 12–30) - You have a confirmed solid tumor such as neuroblastoma, soft tissue sarcoma, osteosarcoma, Ewing sarcoma, or Wilms tumor - Your cancer has come back or is not responding to standard treatments - Your tumor tissue is available for testing (or you are willing to have a biopsy) - You have reasonable blood counts, kidney, liver, and heart function **You may NOT be eligible if...** - You are currently in another clinical trial - You have untreated brain tumors (treated and stable ones may be acceptable) - You have an active, uncontrolled infection - You have HIV, active hepatitis B or C - You have had a serious heart event in the past 12 months - You have an autoimmune condition requiring immune-suppressing medication - You are pregnant or breastfeeding 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

DRUGB7-H3CART Dose (Intravenous)

Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level -1 (DL-1) 0.3 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 1 (DL1) 1 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 2 (DL2) 3 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 2 (DL2) 3 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 3 (DL3) 9 x 106 transduced T cells/kg


Locations(1)

Stanford University

Palo Alto, California, United States

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NCT06500819


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