Is NCT07172958 recruiting in Washington Dc, DC?

Yes, NCT07172958 is currently recruiting participants at its Washington Dc, DC location. This rhabdomyosarcoma clinical trial is actively enrolling qualified participants.

How do I join the rhabdomyosarcoma clinical trial in Washington Dc?

To join this clinical trial in Washington Dc, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Washington Dc clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Rhabdomyosarcoma Clinical Trial in Washington Dc, DC

About This Rhabdomyosarcoma Study in Washington Dc

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. Both doses will be based on the recipient's body weight. The safety of the CAR-TA T cell product will be evaluated and the maximum tolerated dose (MTD) will be determined. The safety endpoint will be assessed by monitoring for dose limiting toxicities for 28 days following CAR-TA T cell administration.

Sponsor: Children's National Research Institute

Who Can Participate

Inclusion Criteria

Recipient Inclusion Criteria 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 unacceptable toxicity or contraindication

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 administration of the CAR-TA T cells

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 above

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 non-myelosuppressive regimen.

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 and the patient has measurable/evaluable disease outside the radiation port or the site of radiation has documented progression.

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 non-myeloablative therapy do not have a wash-out period; they are eligible once they meet all other eligibility requirements, including recovery from acute side effects.

Investigational agent: at least 28 days since receiving an investigational agent.

Patient or parent/guardian capable of providing informed consent. Recipient Inclusion Criteria 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 clearance or glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m for patients with levels above

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.

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 the patient has measurable/evaluable disease outside the radiation port or the site of radiation has documented progression.

Investigational agent: At least 28 days since receiving an investigational agent.

Patient or parent/guardian capable of providing informed consent.

Exclusion Criteria

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 efficacy

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Washington Dc?

Yes, this clinical trial (NCT07172958) has an active research site in Washington Dc, DC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Rhabdomyosarcoma Treatment Options in Washington Dc, DC

If you're searching for rhabdomyosarcoma treatment options in Washington Dc, DC, this clinical trial (NCT07172958) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Washington Dc research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced rhabdomyosarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all rhabdomyosarcoma clinical trials near you to find additional studies recruiting in your area.

Rhabdomyosarcoma Clinical Trial in Washington Dc, DC

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