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GT801

Phase 1

B-cell Acute Lymphoblastic Leukemia (B-ALL) | Monoclonal antibody | Oncology |China Pharma Holdings, Inc.|Last Updated: May 27, 2026

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 Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07205315A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic AnemiaEARLY_PHASE1 RECRUITING 28 — — Sep 26, 2025Aug 31, 2028May 27, 20262 China
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Study Endpoints
Primary Endpoints
Proportion of participants experiencing dose limiting toxicity
28 days

Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion

Incidence and severity of adverse events
3 months post GT801 infusion

Incidence and severity of adverse events per NCI-CTCAE version 5.0

Secondary Endpoints
3rd month Overall response rate (ORR) of hematological malignancy
From the date of infusion to the 3rd month
Best Overall Response (BOR) of hematological malignancy
Up to 12 months post infusion
Duration of Response (DoR) of hematological malignancy
Up to 12 months post infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GT801 Injection treatment groupEXPERIMENTALGT801 Injection
Interventions
NameTypeDescription
GT801 InjectionBIOLOGICALGT801 Injection
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Aged 18 to 75 years (inclusive), male or female; * Participants with refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL), B-cell Non-Hodgkin's Lymphoma (B-NHL) confirmed by the WHO 2016 Classification, or Autoimmune Hemolytic ...

Countries:China
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