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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06839976
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • CAR T Cell
  • CART19
  • Cell Therapy
  • Lupus
  • Lupus Nephritis (LN)
  • SLE
  • Systemic Lupus Erythematosus (SLE)

Eligibility Criteria

Sex
ALL
Age
12 Years - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • CART19 — BIOLOGICAL
    CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection.

Study Details

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.

Key Dates

Start date
May 6, 2025
Status verified
Feb 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CART19
    Participants will receive the study product. CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection.

Primary Outcome Measure

Frequency of the dose limiting toxicities of CART19 [ Time Frame: up to 24 months post infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Caitlin Elgarten, MD
[email protected]
267-425-7964
Melissa Varghese
[email protected]
845-553-5358
Caitlin Elgarten, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Children's Hospital of Philadelphia· Philadelphia, PA

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