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GT719

Phase 1

Hematological Malignancy (Leukemia- Lymphoma) | Monoclonal antibody | Oncology |China Pharma Holdings, Inc.|Last Updated: Sep 16, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06948981GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell MalignanciesPHASE1 RECRUITING 46 — — Apr 18, 2025Apr 17, 2028Sep 16, 20251 China
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Study Endpoints
Primary Endpoints
Incidence and severity of adverse events per CTCAE 5.0
From infusion to the end of the treatment at 12 months

To characterize the safety profile of GT719 in patients with recurrent/refractory CD19 positive adult B-cell malignant hematological tumor as measured by the incidence and severity of adverse events per CTCAE 5.0

Secondary Endpoints
Objective response rate
28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GT719 Injection treatment groupEXPERIMENTALGT719 Injection
Interventions
NameTypeDescription
GT719 InjectionBIOLOGICALGT719 Injection
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol. \- 2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1. \- 3. CD19 positivity confirmed by flow cytometry and...

Countries:China
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