B7-H3 CAR T-cell therapy for pediatric solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of genetically engineered T cells that target the B7-H3 protein in pediatric patients with relapsed or refractory solid tumors. It is a Phase I trial that aims to determine the safety and maximum tolerated dose of these B7-H3-CAR T cells following lymphodepleting chemotherapy. The study will also evaluate the antitumor activity of the treatment and assess changes in the tumor environment post-infusion. Participants will receive a single infusion of the CAR T cells, and the study will last for one year, including a follow-up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Procurement and T-cell production eligibility\*

\*a previously collected, autologous leukapheresis product can be used for T-cell production

* Age ≤21 years old
* 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
* Estimated life expectancy of \>12 weeks
* Karnofsky or Lansky (age-dependent) performance score ≥50
* For females of child bearing 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

Exclusion Criteria:

* Known primary immunodeficiency
* Known HIV positivity
* Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)
* History of hypersensitivity reactions to murine protein-containing products
* Rapidly progressive disease (in the opinion of the study PIs)

Inclusion criteria

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 defined as creatinine clearance or radioisotope GFR 50 ml/min/1.73m2 (GFR 40 ml/min/1.73m2 if \< 2 years of age)
* Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value
* Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
* 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 child bearing 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

Exclusion criteria

* Known primary immunodeficiency
* History of HIV infection
* Severe, uncontrolled intercurrent bacterial, viral or fungal infection
* History of hypersensitivity reactions to murine protein-containing products
* 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
* Receiving systemic therapy in the 14 days prior to CAR T-cell infusion, which will interfere with the activity of the B7-H3-CAR product (in the opinion of the study PIs).
* Rapidly progressing disease (in the opinion of the study PIs)

Where it's running

• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Chris DeRenzo, MD — St. Jude Children's Research Hospital
• Study coordinator: Chris DeRenzo, MD
• Email: referralinfo@stjude.org
• Phone: 888-226-4343

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Alpha/beta T‑Cell and B‑Cell Depletion plus Zoledronic Acid for Pediatric and Young Adult Solid Tumors

  This study will try removing alpha/beta T cells and B cells from donor stem cell grafts and giving zoledronic acid to see if it helps children and young adults (6 months to 25 years) with relapsed or high‑risk solid tumors tolerate allogeneic transplant and reduce relapse.

  Recruiting Phase 1/2 University of Florida · Gainesville, Florida · NCT06625190

• Methionine-Reduced Diet in Solid Tumors (early-phase)

  A small pilot study will test whether a methionine-reduced diet can change blood levels in adults with various solid tumors who are receiving standard cancer therapy.

  Recruiting Early Phase 1 University of California, Irvine · Orange, California · NCT07628634

• Combining vorinostat with chemotherapy for relapsed solid tumors and CNS cancers

  This study is testing if adding a drug called vorinostat to chemotherapy can help people with relapsed solid tumors and brain cancers feel better and improve their treatment outcomes.

  Recruiting Phase 1 New York Medical College · Valhalla, New York · NCT04308330

• Adaptive Proton Therapy for Pediatric Solid Tumors and Hodgkin Lymphoma

  This study tests a regular imaging approach to see if proton therapy plans for children with solid tumors or Hodgkin lymphoma should be updated during treatment.

  Recruiting St. Jude Children's Research Hospital · Memphis, Tennessee · NCT07514819

• Personalized B7-H3 CAR T cells combined with PRAME antigen-specific T cells for relapsed embryonal tumors

  This trial tests a combined personalized B7-H3 CAR T cell and PRAME-specific T cell infusion after lymphodepleting chemotherapy in children and young adults with relapsed or refractory embryonal tumors.

  Recruiting Phase 1 Children's National Research Institute · Washington D.C., District of Columbia and 1 other locations · NCT07172958

• Using silmitasertib with chemotherapy for relapsed solid tumors

  This study is testing a new drug called silmitasertib combined with chemotherapy to see if it helps people with relapsed solid tumors feel better and manage their cancer.

  Recruiting at 24 sites Phase 1/2 Milton S. Hershey Medical Center · Birmingham, Alabama and 23 other locations · NCT06541262

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.