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New treatment option for Pediatric Solid Tumor
Official title B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
ClinicalTrials.gov ID: NCT04897321
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pediatric solid tumor.
Also referred to as Fludara.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 21
You may be able to join if
- 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...
- Estimated life expectancy of \>12 weeks
- Karnofsky or Lansky (age-dependent) performance score ≥50
You likely can't join if
- 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
See the full eligibility 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
- 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 people 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)
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.