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CAR T-cell Therapy

CAR T-Cell Therapy for Pediatric Cancer

Phase 1
Recruiting
Led By Chris DeRenzo, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treatment eligibility: Age ≤21 years old, B7-H3+ solid tumor with measurable disease, Evidence of relapsed or refractory disease after standard first-line therapy, Estimated life expectancy of >8 weeks, Karnofsky or Lansky (age-dependent) performance score≥50, Echocardiogram with a ventricular ejection fraction >40%; or shortening fraction ≥25%, Adequate renal function, Adequate pulmonary function, Total Bilirubin ≤3 times the upper limit of normal for age, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age, Hemoglobin≥ 7g/dL (can be transfused), Platelet count >50,000/uL (can be transfused), Absolute neutrophil count (ANC) ≥ 1000/uL, Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy, For females of childbearing age: Not pregnant with negative serum pregnancy test within 7 days prior to enrollment, Not lactating with intent to breastfeed, If sexually active, agreement to use birth control until 3 months after T-cell infusion. Male partners should use a condom, Available autologous transduced T-cell product that has met GMP release criteria, Agreement to participate in long-term follow-up protocol for patients, who have received genetically modified cell products
For females of childbearing age: Not pregnant with negative serum pregnancy test within 7 days prior to enrollment, Not lactating with intent to breastfeed, Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after b7-h3-car t cell infusion
Awards & highlights

Study Summary

This trial is for patients ≤ 21 years old with relapsed/refractory B7-H3+ solid tumors, investigating the use of autologous T cells genetically engineered to express B7-H3-CARs. The study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.

Who is the study for?
This trial is for children and young adults (≤21 years old) with certain solid tumors that have come back or didn't respond to treatment. Participants must have a life expectancy of more than 8 weeks, a performance score ≥50, good heart function, adequate kidney and lung function, not be pregnant or breastfeeding, agree to use birth control methods if applicable, and have an available T-cell product made from their own cells.Check my eligibility
What is being tested?
The trial tests B7-H3-CAR T cell therapy in pediatric patients with relapsed/refractory solid tumors expressing B7-H3. It aims to find the highest safe dose of these genetically modified T cells after chemotherapy that depletes lymphocytes (a type of white blood cell).See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever, fatigue, changes in blood pressure or breathing difficulties; organ inflammation; possible allergic reactions due to murine protein content; and other typical risks associated with chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or breastfeeding and can undergo or have had apheresis.
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My tumor is B7-H3 positive and can be measured.
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I am 21 years old or younger.
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I can do most activities but may need help.
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I have a previously collected sample for T-cell production.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after b7-h3-car t cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after b7-h3-car t cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of B7-H3-CAR T cells
Secondary outcome measures
Clinical Response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment PhaseExperimental Treatment4 Interventions
During the treatment phase, the participant receives an infusion of the B7-H3-CAR T cells that were made in the Collection and Manufacturing Phase. Chemotherapy is given for several days prior to the cellular infusion. Patients are then monitored for possible side effects, as well as effects of the treatment on their cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MESNA
2004
Completed Phase 2
~60
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
427 Previous Clinical Trials
5,306,545 Total Patients Enrolled
Chris DeRenzo, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

B7-H3 CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04897321 — Phase 1
Solid Tumors Research Study Groups: Treatment Phase
Solid Tumors Clinical Trial 2023: B7-H3 CAR T cells Highlights & Side Effects. Trial Name: NCT04897321 — Phase 1
B7-H3 CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04897321 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this treatment been explored in previous experimental investigations?

"Currently, 893 clinical trials are assessing the efficacy of this medication. Out of those active studies, 161 have reached Phase 3 status. While most trials for this treatment are being conducted in Philadelphia, Pennsylvania, 28460 locations around the world possess a research presence for it."

Answered by AI

How many participants are currently being admitted to this research endeavor?

"Correct. According to records on clinicaltrials.gov, this study is actively recruiting participants since its launch date of June 29th 2022 and has been recently updated on the 30th. The trial requires 32 individuals at one medical centre."

Answered by AI

Is this treatment a secure option for individuals?

"The safety of this treatment is rated a 1 on our scale because, as it stands in Phase 1, there are only minimal studies to back up its efficacy and risk-profile."

Answered by AI

What indications does this treatment typically address?

"While this remedy is typically used for the treatment of multiple sclerosis, it may also be effective in treating leukaemia, myelocytic acute conditions and retinoblastoma as well as histiocytic lymphoma."

Answered by AI

Are there still openings for participants in this clinical research?

"That is accurate. Clinicaltrials.gov holds the record that this clinical trial, initially posted on June 29th 2022, has remained open for participant recruitment. A total of 32 patients are desired from a single site."

Answered by AI

Who else is applying?

What site did they apply to?
St. Jude Children's Research Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
2022. "B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04897321.
All > Osteosarcoma > Rhabdomyosarcoma
~16 spots leftby Mar 2026
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