Is NCT06839976 recruiting in Philadelphia, PA?

Yes, NCT06839976 is currently recruiting participants at its Philadelphia, PA location. This sle clinical trial is actively enrolling qualified participants.

How do I join the sle clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, 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 Philadelphia 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.

SLE Clinical Trial in Philadelphia, PA

About This SLE Study in Philadelphia

This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Phase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.

Sponsor: Children's Hospital of Philadelphia

Who Can Participate

Inclusion Criteria

Signed informed consent form must be obtained prior to any study procedure. Labs or other procedures obtained during routine clinical care may be used for eligibility if obtained within the protocol required window.

Patient age must be 12-29 years, inclusive, at time of enrollment.

Meeting ACR/EULAR Classification Criteria for SLE

ANA positive \> 1:80 and/or double-stranded DNA (dsDNA) positive

Active (refractory) disease, defined as follows: a. Lupus nephritis subjects must meet both the following criteria: i. ISN/RPS active nephritis Class III/IV +/- V lupus nephritis diagnosed by biopsy within past 12 months. ii. Persistent and clinically significant: ≥2 measurements with urine protein with either of the following:

\> 1mg/mg creatinine

\> 0.5 mg/mg creatinine associated with renal dysfunction or low albumin.

\> 0.5 mg/mg creatinine in a patient with rising proteinuria after prior complete renal response b. Non-renal SLE subjects must meet either of the following criteria: i. SLEDAI-2K ≥ 8 and clinical SLEDAI-2K ≥ 6 ii. Inability to decrease prednisone ≤7.5mg/day or 0.15mg/kg/day, whichever is lower, due to active disease. 6\. Patients must have had at least 3 months of cumulative conventional therapy defined as:

Conventional induction immunosuppressive agent(s) (e.g., mycophenolate mofetil, cyclophosphamide), and

At least one additional therapy: i. B-cell directed biologic therapy (e.g., rituximab, belimumab, ofatumumab, obinutuzumab) ii. Calcineurin inhibitor (e.g., tacrolimus, cyclosporine, voclosporin) iii. Other immunosuppressive medication for SLE (e.g., anifrolumab, abatacept, JAK inhibitor) 7. Adequate organ function status

Renal: eGFR must be ≥30 and subject cannot be receiving dialysis.

Hepatic: Transaminases \< 5x upper limit of normal and serum conjugated (Direct) bilirubin \<1.5x upper limit of normal unless attributable to SLE. If attributable to autoimmune disease, Child-Pugh score must be class A or class B. Child-Pugh score cannot be class C.

Cardiac: Shortening fraction \> 28%, left ventricular ejection fraction \>45%, and no evidence of severe pulmonary hypertension

Pulmonary: Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \<Grade 3 hypoxia; DLCO ≥40% (corrected for anemia and/or VA volume if necessary) if PFTs are clinically appropriate as determined by the treating investigator. 8\. Subjects of reproductive potential must agree to use acceptable birth control methods.

Exclusion Criteria

Active, untreated infections

HIV infection

Active Hepatitis B a. Patients must have a negative hepatitis B surface antigen to be enrolled on this study.

Active Hepatitis C

Patients with severe neuropsychiatric lupus or neurologic manifestations of SLE (e.g. stroke, seizure, psychosis, demyelinating syndromes, organic brain syndrome, or lupus related headaches)

Monogenic lupus (known)

Previous autologous or allogenic stem cell transplant

Previous kidney transplant

History of seizure disorder

Patients who are on anti-epileptic therapy

Participation in a clinical trial in which the patient receives an investigational drug within a time period equal or less than 5.5 half-lives of the investigational agent prior to study enrollment.

Subjects who are unwilling or unable to discontinue immunosuppressive medications at the times of CART19 infusion will be excluded from the trial

Any comorbidity that in the opinion of the investigators would jeopardize the ability of the subject to tolerate therapy.

Pregnant patients. All participants of childbearing potential must have negative pregnancy test.

Lactating participants who want to continue breastfeeding.

Patients who are unwilling to consent to LTFU

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 Philadelphia?

Yes, this clinical trial (NCT06839976) has an active research site in Philadelphia, PA 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.

SLE Treatment Options in Philadelphia, PA

If you're searching for sle treatment options in Philadelphia, PA, this clinical trial (NCT06839976) 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 Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced sle 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 sle clinical trials near you to find additional studies recruiting in your area.

SLE Clinical Trial in Philadelphia, PA

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IRB Approved

No-Cost Care

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