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CD19-targetd CAR-T

Phase 1

Juvenile Dermatomyositis | Monoclonal antibody | Immunology |Precision BioSciences, Inc.|Last Updated: Aug 26, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

CD19-targetd CAR-T · 1 trial · 1 indication

Phase 1 1
NCT06569472Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile DermatomyositisJuvenile Dermatomyositis
RECRUITING10 Analytics
PHASE1RECRUITING
Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile Dermatomyositis
Juvenile DermatomyositisUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety of CAR-T in the treatment of refractory juvenile dermatomyositis [Safety and Tolerability]
28 days

The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).including the type, frequency and severity of adverse events

To evaluate the efficacy of CAR-T in the treatment of refractory juvenile dermatomyositis [Effectiveness]
2month,3months

Disease improvement rate: The number of subjects who achieved disease improvement as a percentage of all subjects who received transfusions.

Duration of Response (DOR) of CAR-T treatment in the treatment of refractory juvenile dermatomyositis [Effectiveness]
2 years

DOR will be assessed from the first assessment of remission to the first assessment of recurrence or progression of the disease or death from any cause

Secondary Endpoints

AUCS of CD19 CAR-T cells [Cell dynamics]
3 months
CMAX of CD19 CAR-T cells [Cell dynamics]
3 months
TMAX of CD19 CAR-T cells[Cell dynamics]
3 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CD19-targeted CAR-TEXPERIMENTALThe experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).

Interventions

NameTypeDescription
CD19-targetd CAR-TBIOLOGICALSubjects underwent lymphocyte clearance chemotherapy and then received a single intravenous cell infusion
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Eligibility Criteria

Age Range5 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age: ≥5 years and \<17 years old 2. To meet the diagnostic criteria of JDM, four or five of the following criteria must be met:① symmetrical proximal muscle weakness; ②Characteristic skin changes, including positive dermatitis (purplish red rash on upper eyelid with periorbit...

Countries:China
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Frequently asked questions about CD19-targetd CAR-T

What is CD19-targeted CAR-T used for in Juvenile Dermatomyositis?

CD19-targeted CAR-T is an investigational cell therapy being studied for refractory Juvenile Dermatomyositis, a rare autoimmune disease in children. It is designed to target CD19-positive cells as part of the treatment approach. The therapy is currently in Phase 1 clinical development and is not yet approved for any use.

Who is developing CD19-targeted CAR-T?

Precision BioSciences, Inc. (NASDAQ: DTIL) is developing CD19-targeted CAR-T. The company is conducting a Phase 1 clinical trial for this therapy in patients with refractory Juvenile Dermatomyositis. The trial is currently recruiting participants in China.

What phase is CD19-targeted CAR-T in?

CD19-targeted CAR-T is in Phase 1 clinical development. It is an investigational therapy being studied for refractory Juvenile Dermatomyositis. The therapy is not yet approved by regulatory authorities and remains in the early stages of clinical testing.

What clinical trials is CD19-targeted CAR-T in?

CD19-targeted CAR-T is being evaluated in a Phase 1 clinical trial with the identifier NCT06569472. The trial is titled 'Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile Dermatomyositis' and is currently recruiting. It plans to enroll 10 participants aged 5 years and older in China.

How does CD19-targeted CAR-T work?

CD19-targeted CAR-T is designed to target CD19, a protein found on the surface of certain immune cells. By targeting CD19-positive cells, the therapy aims to modulate the immune response in Juvenile Dermatomyositis. The exact mechanism is being studied in the ongoing Phase 1 clinical trial.