CART19 for Systemic Lupus Erythematosus

CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus

Recruiting Phase 1 Phase 2 Interventional Study
SLE Systemic Lupus Erythematosus (SLE) CAR T Cell CART19 Cell Therapy Lupus Lupus Nephritis (LN)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 – 29
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Children's Hospital of Philadelphia · Other
Who this trial is looking for

This trial is looking for children and young adults aged 12 to 29 who have severe lupus that hasn't responded to other treatments. Participants will receive a new type of cell therapy called CART19 and will be monitored for safety and effectiveness.

Are You a Good Fit for This Trial?
Rules you out HIV infectionActive Hepatitis BActive Hepatitis CSevere neuropsychiatric lupus

You may be able to join if

  • I am aged 12 to 29 years old.
  • I have active lupus.
  • I meet the criteria for lupus diagnosis.
  • I have taken other lupus treatments for at least 3 months.
  • I am willing to use birth control if needed.
  • I have a signed consent form.
  • I have adequate organ function.

You may not be able to join if

  • I have an active or untreated infection.
  • I have been diagnosed with HIV.
  • I have active Hepatitis B or C.
  • I have severe neuropsychiatric issues related to lupus.
  • I have had a stem cell transplant.
  • I have a history of seizure disorder.
  • I am pregnant or breastfeeding.
  • I cannot stop my immunosuppressive medications before treatment.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Patient age must be 12-29 years, inclusive, at time of en…
Contacts

Caitlin Elgarten, MD

267-425-7964

elgartenc@chop.edu

CONTACT

Melissa Varghese

845-553-5358

verghesem@chop.edu

CONTACT