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Anti-CD19 UCAR-T cells

Phase 1

Dermatomyositis, Juvenile | Small molecule | Immunology |Precision BioSciences, Inc.|Last Updated: Nov 13, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Anti-CD19 UCAR-T cells · 1 trial · 2 indications

Phase 1 1
NCT06686524Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM)Dermatomyositis, Juvenile
RECRUITING18 Analytics
PHASE1RECRUITING
Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM)
Dermatomyositis, JuvenileUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
28 dyas

The incidence of adverse events after CAR-T cell infusion was assessed by CTCAE, version 5.0.

Total improvement score (TIS) after anti-CD19 UCAR-T cells infusion.
6 months

The total improvement score between 0-100 also corresponds to the degree of improvement, with higher improvement scores indicating greater improvement.

Disease Activity Score (DAS) after anti-CD19 UCAR-T cells infusion.
6 months

Including musculoskeletal system score and skin mucosal score, with a total score of 20 points. The higher the score, the higher the disease activity

Changes of myositis specific antibody levels and serum muscle enzyme levels after anti-CD19 UCAR-T cells infusion.
6 months
Improvement in muscle inflammation infiltration by MRI after anti-CD19 UCAR-T cells infusion.
6 months
Childhood Myositis Assessment Scale (CMAS) score after anti-CD19 UCAR-T cells
6 months

The total score is 52 points, the lower the score, the weaker the muscle strength and the more severe the disease.

Secondary Endpoints

Cmax of anti-CD19 UCAR-T cells [Cell dynamics]
1 month
Tmax of anti-CD19 UCAR-T cells [Cell dynamics]
1 month
AUCs of anti-CD19 UCAR-T cells [Cell dynamics]
1 month
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Anti-CD19 UCAR-T cellsEXPERIMENTAL -

Interventions

NameTypeDescription
Anti-CD19 UCAR-T cellsDRUGA single infusion of CD19 UCAR-T cells will be administered intravenously after lymphodepletion chemotherapy.
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Eligibility Criteria

Age Range5 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * (1) Age ≥ 5 years old; * (2) Diagnosis of juvenile dermatomyositis (JDM) according to Bohan and Peter criteria; * (3) Meeting the classification criteria for RJDM, and meeting condition ① and any one of ② to ⑤ conditions: * Intolerance or inadequate response to glucocortico...

Countries:China
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Frequently asked questions about Anti-CD19 UCAR-T cells

What is Anti-CD19 UCAR-T cells used for in juvenile dermatomyositis?

Anti-CD19 UCAR-T cells is an investigational cell therapy being studied for the treatment of refractory juvenile dermatomyositis (RJDM). It is designed to target CD19, a protein on B cells, and is currently in Phase 1 clinical development. The therapy is being evaluated in a clinical trial in China.

What does Anti-CD19 UCAR-T cells target?

Anti-CD19 UCAR-T cells targets CD19, a cell surface protein expressed on B cells. By targeting CD19, the therapy aims to deplete B cells, which are thought to play a role in the autoimmune pathology of juvenile dermatomyositis. This mechanism is being investigated in a Phase 1 clinical trial.

Who is developing Anti-CD19 UCAR-T cells?

Anti-CD19 UCAR-T cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The therapy is currently in Phase 1 clinical development for refractory juvenile dermatomyositis.

What phase is Anti-CD19 UCAR-T cells in?

Anti-CD19 UCAR-T cells is in Phase 1 clinical development. It is an investigational therapy, not yet approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate the treatment for refractory juvenile dermatomyositis.

What clinical trials is Anti-CD19 UCAR-T cells in?

Anti-CD19 UCAR-T cells is being studied in a Phase 1 clinical trial with the identifier NCT06686524. The trial is titled 'Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM)' and is recruiting participants in China.