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New treatment option for Sarcoma
Official title Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas
ClinicalTrials.gov ID: NCT07222735
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 sarcoma.
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
- RAD3CAR is a phase I study designed to evaluatethe safety of B7-H3-CAR T cells and lymphodepletion in combination with hypofractionated radiation therapy. Primary objective: \- To evaluate the safety of B7-H3-CAR T cell therapy after priming with hypofractionated radiation therapy (HFRT) and lymphodepleting chemotherapy in patients ≤ 21 years of age with relapsed/refractory B7-H3+ sarcomas.
- 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
- \ a previously collected, autologous leukapheresis product can be used for T cell production Collection and manufacturing eligibility
- Age ≤ 21 years old
- B7-H3+ sarcoma; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using any previously obtained biopsy; a tumor is considered...
- Osteosarcoma
- Ewing Sarcoma
You likely can't join if
- Collection and manufacturing eligibility
- Known primary immunodeficiency
- Known HIV positivity
- Severe, uncontrolled intercurrent bacterial, viral, or fungal infection
- Known active malignancy other than the B7-H3+ sarcoma being treated on study
- Rapidly progressive disease (as assessed by the study PIs, with consideration for proximity to critical structures)
See the full eligibility criteria
Who can join
- \ a previously collected, autologous leukapheresis product can be used for T cell production Collection and manufacturing eligibility
- Age ≤ 21 years old
- B7-H3+ sarcoma; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using any previously obtained biopsy; a tumor is considered B7-H3 positive with a H score greater than or equal to 100
- Osteosarcoma
- Ewing Sarcoma
- Rhabdomyosarcoma Non-rhabdomyosarcoma soft tissue sarcomas
- Evidence of relapsed (cancer that has completely responded [i.e., no evidence of disease using standard imaging modalities] to first-line therapy but has recurred for the first or subsequent time); or refractory (cancer...
- Evaluable disease with presence of at least one lesion amenable to hypofractionated radiation therapy
- For dose expansion cohort: participants must also have additional evaluable disease beyond planned radiation field
- Estimated life expectancy of \> 12 weeks
- Karnofsky or Lansky (age-dependent) performance score ≥ 60
- Participants with mobility limitations due to prior surgical intervention (i.e., amputation) but who are up in wheelchair or with other assistive devices will be considered ambulatory for the purpose of performance...
- 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
- Participants must be eligible to undergo autologous apheresis or have an available previously collected autologous apheresis product Treatment eligibility
- Age ≤ 21 years old at the time of manufacturing
- B7-H3+ sarcoma
- Evidence of relapsed or refractory disease after standard first-line therapy
- Evaluable disease with the presence of at least one lesion amenable to hypofractionated radiation therapy
- For dose expansion cohort: participants must also have additional evaluable disease beyond the planned radiation field
- Estimated life expectancy of \> 8 weeks
- Karnofsky or Lansky (age-dependent) performance score ≥ 60
- Participants with mobility limitations due to prior surgical intervention (i.e., amputation) but who are up in wheelchair or with other assistive device will be considered ambulatory for purpose of performance score...
- Adequate cardiac function defined by echocardiogram with left ventricular ejection fraction ≥ 50%
- Adequate renal function as defined by not exceeding the maximum serum creatinine listed below by age:
- 1 to \<2 years: 0.6
- 2 to \<6 years: 0.8
- 6 to \<10 years: 1
- 10 to \<13 years: 1.2
- 13 to \<16 years: male 1.5, female 1.4
- ≥ 16 years: male 1.7, female 1.4
- Adequate pulmonary function defined as pulse oximetry ≥ 92% on room air
- 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/μL (can be transfused)
- Absolute neutrophil count (ANC) ≥ 1000/μL
- 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 contraception until 3 months after T cell infusion
What rules you out
- Collection and manufacturing eligibility
- Known primary immunodeficiency
- Known HIV positivity
- Severe, uncontrolled intercurrent bacterial, viral, or fungal infection
- Known active malignancy other than the B7-H3+ sarcoma being treated on study
- Rapidly progressive disease (as assessed by the study PIs, with consideration for proximity to critical structures)
- Presence of intracranial or spinal cord disease
- Known underlying medical condition(s) for which, in the investigator's opinion, participation in this trial would not be in the best interest of the participant (e.g., compromises the health of the subject) or that...
- Known severe hypersensitivity to corn starch or hydroxyethyl starch Treatment eligibility
- Known primary immunodeficiency
- Known HIV positivity
- Severe, uncontrolled intercurrent bacterial, viral, or fungal infection
- Known active malignancy other than the B7-H3+ sarcoma being treated on study
- Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, \< 7 days prior to CAR T cell infusion
- Receiving systemic therapy \< 14 days prior to start of protocol therapy, which will interfere with the activity of the CAR product (in the opinion of the study PIs)
- Received radiation therapy within the 4 weeks prior to start of protocol therapy
- Rapidly progressive disease (as assessed by the study PIs, with consideration for proximity to critical structures)
- Presence of intracranial or spinal cord disease
- Known underlying medical condition(s) for which, in the investigator's opinion, participation in this trial would not be in the best interest of the participant (e.g., compromises the health of the subject) or that...
- Known severe hypersensitivity to corn starch or hydroxyethyl starch
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.