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CD19 and CD22 targeted prime CAR-T cells

Phase 1

B-ALL | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Feb 25, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

CD19 and CD22 targeted prime CAR-T cells · 1 trial · 1 indication

Phase 1 1
NCT04781634a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALLB-ALL
RECRUITING40 Analytics
PHASE1RECRUITING
a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL
B-ALLUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events that related to treatment
2 years

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B-ALL
6 months

The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline

Secondary Endpoints

Rate of prime CAR-T cells in bone marrow
2 years
Rate of prime CAR-T cells in peripheral blood
2 years
Quantity of prime CAR copies in bone marrow
2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
prime CAR- T cellsEXPERIMENTALPatients will be be treated with CD19 and CD22 prime CAR- T cells

Interventions

NameTypeDescription
CD19 and CD22 targeted prime CAR-T cellsBIOLOGICALA single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously
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Eligibility Criteria

Age Range2 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed written informed consent 2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory patients ; 3. Relapse after hemat...

Countries:China
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Frequently asked questions about CD19 and CD22 targeted prime CAR-T cells

What is CD19 and CD22 targeted prime CAR-T cells used for?

CD19 and CD22 targeted prime CAR-T cells is an investigational cell therapy being studied for the treatment of relapsed or refractory B-ALL (B-cell acute lymphoblastic leukemia). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does CD19 and CD22 targeted prime CAR-T cells target?

CD19 and CD22 targeted prime CAR-T cells targets the CD19 and CD22 proteins, which are found on the surface of B cells. By engineering a patient's T cells to recognize these targets, the therapy aims to direct the immune system against cancerous B cells in B-ALL.

Who is developing CD19 and CD22 targeted prime CAR-T cells?

CD19 and CD22 targeted prime CAR-T cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DTIL. The company is conducting a Phase 1 clinical trial for this investigational therapy.

What phase is CD19 and CD22 targeted prime CAR-T cells in?

CD19 and CD22 targeted prime CAR-T cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not yet been approved by the FDA or other regulatory bodies, and its safety and efficacy are still being evaluated in clinical trials.

What clinical trials is CD19 and CD22 targeted prime CAR-T cells in?

CD19 and CD22 targeted prime CAR-T cells is being studied in a Phase 1 clinical trial registered as NCT04781634. This trial is recruiting 40 participants with relapsed or refractory B-ALL in China, and it is currently active and enrolling patients.