Recent Updates
Recently added Catalysts

CD19 and CD22 targeted prime CAR-T cells

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04781634a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALLPHASE1 RECRUITING 40Mar 7, 2021Jul 1, 2027Feb 25, 20251 China
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range2 Years — 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
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04781634studyFirstPostDate: changed