Is NCT07222735 recruiting in Memphis, TN?

Yes, NCT07222735 is currently recruiting participants at its Memphis, TN location. This sarcoma clinical trial is actively enrolling qualified participants.

How do I join the sarcoma clinical trial in Memphis?

To join this clinical trial in Memphis, 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 Memphis 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.

Sarcoma Clinical Trial in Memphis, TN

About This Sarcoma Study in Memphis

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. Secondary objectives: * To describe the antitumor activity of B7-H3-CAR T cells in combination with HFRT * To determine if B7-H3-CAR T cells traffic to tumor sites after combination treatment with HFRT

Sponsor: St. Jude Children's Research Hospital

Who Can Participate

Inclusion Criteria

\*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 that does not respond completely to treatment; cancer may be resistant at the beginning or may become resistant during treatment) disease after standard first-line therapy

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 score determination

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 determination.

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 subjects 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

Exclusion Criteria

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 could prevent, limit, or confound protocol assessments

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 severe hypersensitivity to corn starch or hydroxyethyl starch

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 Memphis?

Yes, this clinical trial (NCT07222735) has an active research site in Memphis, TN 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.

Sarcoma Treatment Options in Memphis, TN

If you're searching for sarcoma treatment options in Memphis, TN, this clinical trial (NCT07222735) 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 Memphis research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced sarcoma 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 sarcoma clinical trials near you to find additional studies recruiting in your area.

Sarcoma Clinical Trial in Memphis, TN

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IRB Approved

No-Cost Care

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