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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

B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score ≥100

Must not have

Severe, uncontrolled intercurrent bacterial, viral or fungal infection

Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, in the 7 days prior to B7-H3-CAR T-cell infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after b7-h3-car t cell infusion

Awards & highlights

No Placebo-Only Group

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.

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).

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe, uncontrolled infections.

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I haven't taken high doses of steroids in the week before my planned CAR T-cell therapy.

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I do not have a severe infection like hepatitis B or C.

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I have a history of HIV infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks after b7-h3-car t cell infusion

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of B7-H3-CAR T cells

Secondary study objectives

Clinical Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 4

~1860