RecruitingPhase 1NCT04897321

B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)


Sponsor

St. Jude Children's Research Hospital

Enrollment

48 participants

Start Date

Jul 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives * To evaluate the tumor environment after treatment with B7-H3-CAR T cells * To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a personalized immune cell therapy (CAR-T cell therapy targeting a protein called B7-H3) for children and young adults with solid tumors that have returned or stopped responding to standard first-line treatment. B7-H3 is a protein found on the surface of many childhood cancers. **You may be eligible if...** - You are 21 years old or younger - You have a solid tumor that expresses the B7-H3 protein (confirmed by testing) - Your cancer has relapsed or become resistant to standard first-line therapy - Your expected survival is more than 8 weeks - You have adequate heart, kidney, lung, and liver function - You have adequate blood counts - Females of childbearing age must not be pregnant and agree to use birth control **You may NOT be eligible if...** - You have a known immune deficiency disease or HIV - You have an active serious infection (like hepatitis B or C) - You have had an allergic reaction to mouse-protein-based products in the past - You are on high-dose steroids within 7 days before the infusion - Your disease is rapidly progressing at the time of treatment 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

DRUGFludarabine

Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis. Intravenous

DRUGCyclophosphamide

Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA. Intravenous

DRUGMESNA

Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide

DRUGB7-H3 CAR T cells

The study participant will receive B7-H3-CAR T cells by vein, through either an IV or a central line.


Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT04897321


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