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New treatment option for Rhabdomyosarcoma
Official title Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
ClinicalTrials.gov ID: NCT07172958
What this study is testing
What is Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells?
Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for rhabdomyosarcoma.
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
- This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME Tumor Antigen-specific T cells) following lymphodepleting chemotherapy in participants with relapsed/refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma and Wilms tumor. Patients will be enrolled to one of three planned dose levels with B7-H3 CAR T cell dose determined based on the percentage of B7-H3 transduced cells (B7-H3+ population of cells), and dTBRII-transduced PRAME TA-specific T cell dose based on the total cell population.
- 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 1 to 23
You may be able to join if
- Recipient for Procurement:
- Diagnosis of relapsed/refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor
- Refractory disease, residual detectable disease or relapsed disease following available standard of care therapies with known clinical benefit for...
- Measurable or evaluable disease by imaging, as determined following most recent therapy
- Age ≥ 1 year and \< 24 years
You likely can't join if
- Recipient Procurement Exclusion Criteria:
- Patients with known CNS disease.
- Patients with uncontrolled infection/s or known HIV infection
- Pregnant or lactating females.
- Patients who have undergone previous allogeneic stem cell transplant. Recipient Exclusion Criteria for CAR-TA T cell product Infusions:
- Patients with uncontrolled infections or known HIV infection.
See the full eligibility criteria
Who can join
- Recipient for Procurement:
- Diagnosis of relapsed/refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor
- Refractory disease, residual detectable disease or relapsed disease following available standard of care therapies with known clinical benefit for their specific tumor type, or unable to receive such therapies due to...
- Measurable or evaluable disease by imaging, as determined following most recent therapy
- Age ≥ 1 year and \< 24 years
- Weight \> 10 kg
- No systemic steroid exposure within 1 week of procurement
- Karnofsky/Lansky score of ≥ 60 (See Appendix 3)
- Participants of childbearing potential or capable of fathering a child must agree to use effective contraceptive measure/s (as described in Appendix 5) during study protocol participation through 6 months following the...
- ANC \> 500/µL
- ALC \> 1000/µL
- Platelet count \> 50,000/uL (level can be achieved with transfusion)
- Bilirubin ≤ 2.5 mg/dL
- Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≤ 5x the upper limit of normal for age
- Serum creatinine Maximum serum creatinine (mg/dL) Age Male Female
- to \< 2 years 0.6 0.6
- to \< 6 years 0.8 0.8 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.2 ≥ 16 years 1.7 1.4 OR Creatinine clearance or glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m for patients with levels...
- For FOCBP: Negative pregnancy test
- Pulse oximetry of \> 90% on room air
- Adequate cardiac function defined as: o Shortening fraction of ≥ 27% by echocardiogram, or o Ejection fraction of \> 50% by echocardiogram or radionuclide angiogram (i.e., MUGA).
- No acute neurological toxicity \> grade 1 (with the exception of peripheral sensory neuropathy or controlled seizure disorder on anti-epileptics).
- The following time frames must have elapsed between prior therapy completion and apheresis cell collection:
- Myelosuppressive chemotherapy/immunomodulatory medications: At least 3 weeks, or 6 weeks if prior nitrosourea.
- Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. At least 14 days after receiving pegfilgrastim.
- Biological agent, tyrosine kinase inhibitor, targeted agent, metronomic chemotherapy: At least 7 days since the completion of therapy with a biologic agent, tyrosine kinase inhibitor, targeted agent, or metronomic...
- Monoclonal antibodies and checkpoint inhibitors: At least 3 weeks or 5 half-lives (whichever is shorter) since the last dose of a monoclonal antibody or checkpoint inhibitor.
- Radiotherapy (XRT): At least 3 weeks since XRT, and at least 6 weeks if radiation involved the CNS or lung fields. Exception: There is no time restriction for palliative radiation with minimal bone marrow involvement...
- Autologous stem cell transplant/infusion: At least 6 weeks from their infusion after an autologous stem cell infusion following myeloablative therapy. Patients who received an autologous stem cell infusion following...
- Investigational agent: at least 28 days since receiving an investigational agent.
- Patient or parent/guardian capable of providing informed consent. Recipient for CAR-TA T cell product Infusion:
- No systemic steroid exposure within 1 week prior to protocol therapy initiation
- Karnofsky/Lansky score of ≥ 60 (See Appendix 3)
- ANC \> 750/uL
- Platelet count \> 75,000/uL
- Bilirubin ≤ 2.5 mg/dL
- AST/ALT ≤ 5x the upper limit of normal for age
- Serum creatinine Maximum serum creatinine (mg/dL) Age Male Female 1 to \< 2 years 0.6 0.6 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.2 ≥ 16 years 1.7 1.4 OR Creatinine...
- For FOCBP: Negative pregnancy test
- Participants of childbearing potential or capable of fathering a child must agree to use effective contraceptive measure/s (as described in Appendix 5) through 6 months following the administration of the CAR-TA T cells
- Adequate respiratory function defined as oxygen saturation 90% or higher on room air
- No acute neurological toxicity \> grade 1 (with the exception of peripheral sensory neuropathy or controlled seizure disorder on anti-epileptics).
- Adequate cardiac function defined as:
- Shortening fraction of ≥ 27% by echocardiogram, or
- Ejection fraction of \> 50% by echocardiogram or radionuclide angiogram
- The following time frames must have elapsed between completion of prior therapy and the initiation of SABRE protocol therapy:
- Myelosuppressive chemotherapy: At least 2 weeks from last dose of chemotherapy.
- Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. At least 14 days after receiving pegfilgrastim.
- Biological agent, tyrosine kinase inhibitor, targeted agent, metronomic chemotherapy: At least 7 days since the completion of therapy with a biologic agent, tyrosine kinase inhibitor, targeted agent, or metronomic...
- Monoclonal antibodies and checkpoint inhibitors: At least 3 weeks or 5 half-lives (whichever is shorter) since the last dose of a monoclonal antibody or checkpoint inhibitor.
- Radiotherapy (XRT): At least 3 weeks since XRT, and at least 6 weeks if radiation involved CNS or lung fields. Exception: There is no time restriction for palliative radiation with minimal bone marrow involvement and...
- Investigational agent: At least 28 days since receiving an investigational agent.
- Patient or parent/guardian capable of providing informed consent.
What rules you out
- Recipient Procurement Exclusion Criteria:
- Patients with known CNS disease.
- Patients with uncontrolled infection/s or known HIV infection
- Pregnant or lactating females.
- Patients who have undergone previous allogeneic stem cell transplant. Recipient Exclusion Criteria for CAR-TA T cell product Infusions:
- Patients with uncontrolled infections or known HIV infection.
- Pregnant or lactating females
- Whole lung/mediastinal radiation within 12 weeks
- Clinically significant systemic illness or medical condition likely to interfere with assessment of safety or how well it works
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 1 year to 23 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, 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.