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New treatment option for Neuroblastoma
Official title Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors
ClinicalTrials.gov ID: NCT06500819
What this study is testing
What is B7-H3CART Dose (Intravenous)?
B7-H3CART Dose (Intravenous) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma.
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
- The purpose of this study is to test the manufacturing feasibility and safety of intravenous (IV) administration of B7-H3CART in children and young adult subjects with relapsed and/or refractory solid tumors expressing B7-H3 target using a standard 3+3 dose escalation design.
- 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 2 to 30
You may be able to join if
- Histologically confirmed malignant solid tumor (including neuroblastoma, soft tissue sarcoma, osteosarcoma, Ewing Sarcoma, and Wilms tumor) with...
- people with neuroblastoma must have received or be intolerant to anti-GD2 antibody therapy.
- people with Wilm's tumor must have received or be intolerant to ifosfamide or cyclophosphamide plus etoposide therapy or alternative salvage regimen.
- people with embryonal rhabdomyosarcoma must have received or be intolerant to Adriamycin-based therapy.
- people with surgically resected pulmonary osteosarcoma in first recurrence must have received surgical resection of metastatic nodules.
You likely can't join if
- Receiving any other current investigational agents.
- History of other malignancy, except non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast), unless disease free for at least 3...
- Presence of untreated brain metastases will be excluded. people with previous CNS tumor involvement that has been treated and is stable for at least...
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled. Simple UTI and uncomplicated bacterial pharyngitis are permitted if...
- Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti HCV positive) as the immunosuppression contained in this study...
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months...
See the full eligibility criteria
Who can join
- Histologically confirmed malignant solid tumor (including neuroblastoma, soft tissue sarcoma, osteosarcoma, Ewing Sarcoma, and Wilms tumor) with evidence of incurable disease and tumor recurrence/progression after all...
- people with neuroblastoma must have received or be intolerant to anti-GD2 antibody therapy.
- people with Wilm's tumor must have received or be intolerant to ifosfamide or cyclophosphamide plus etoposide therapy or alternative salvage regimen.
- people with embryonal rhabdomyosarcoma must have received or be intolerant to Adriamycin-based therapy.
- people with surgically resected pulmonary osteosarcoma in first recurrence must have received surgical resection of metastatic nodules.
- people during dose escalation must have evaluable or measurable disease. people during dose expansion must have measurable disease, except neuroblastoma which may have MIBG positive disease only.
- B7-H3 positive expression on malignant cells is NOT required but archival tissue must be available, or the subject must be willing to undergo tissue biopsy for expression analysis.
- Age: Must be ≥ 2 and ≤ 30 years of age. \ For the first three people treated with B7-H3CART, must be ≥ 12 and ≤ 30 years of age.
- Performance Status: Patients \> 16 years of age must have Karnofsky ≥ 50%. Patients ≤ 16 years of age must have Lansky scale ≥ 50%; or ECOG performance status ≤ 2.
- Prior Therapy
- No limit to the number of prior therapies.
- Prior Therapy Wash-out: At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic...
- Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion)
- ANC ≥ 750/uL\
- Platelet count ≥ 75,000/uL\
- Absolute lymphocyte count ≥ 150/uL\
- Adequate renal, hepatic, pulmonary and cardiac function defined as:
- Creatinine within institutional norms for age(i.e. ≤ 2 mg/dL in adults or according to table below in children \ 10-18 Maximum Serum Creatinine (mg/dL): 1.2 Age (Years): \> 18 Maximum Serum Creatinine (mg/dL): 2.0
- Serum ALT/AST ≤ 2.5x ULN (unless elevated ALT/AST is associated with disease involvement of the liver, in which case this criterion will be waived and not disqualify a patient).
- Total bilirubin ≤ 1.5 mg/dl, except in people with Gilbert's syndrome.
- Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO,
- No clinically significant ECG findings
- No clinically significant pleural effusion
- Baseline oxygen saturation \> 92% on room air
- if cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is due...
- Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of...
- people of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen or for as long as...
- Must provide informed consent. For people \ 7 years of age, when appropriate. If a minor becomes of age during participation of this study, he/she will be asked to reconsent as an adult.
What rules you out
- Receiving any other current investigational agents.
- History of other malignancy, except non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast), unless disease free for at least 3 years.
- Presence of untreated brain metastases will be excluded. people with previous CNS tumor involvement that has been treated and is stable for at least 3 months following completion of therapy are permitted. Patients who...
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
- Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti HCV positive) as the immunosuppression contained in this study will pose unacceptable risk. A history of hepatitis B or hepatitis C...
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.
- Any medical condition that in the judgement of the sponsor investigator is likely to interfere with assessment of safety or how well it works of study treatment.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Pregnant females are excluded from this study because the effects of autologous B7-H3CART on the developing human fetus are unknown and because the chemotherapy agents used in this trial (cyclophosphamide and...
- Primary immunodeficiency or history of systemic autoimmune disease (e.g., Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- Patients who require systemic corticosteroid or other immunosuppressive therapy. (A one-week washout from systemic corticosteroid or other immunosuppressive therapy is permitted.) Use of physiologic doses of...
- In the investigator's judgment, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, 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, 2 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, 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.