Status:
RECRUITING
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Pediatric Solid Tumor
Osteosarcoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Treatment will include a single infusion of B7-H3-CAR T cells after lymphodepleting chemotherapy, with dosing based on the number of CAR+ T cells and patient weight. The study will evaluate the safety...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04897321
Start Date
July 6 2022
End Date
March 1 2027
Last Update
October 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105