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UCART19

Phase 1

B-cell Acute Lymphoblastic Leukemia | Monoclonal antibody | Oncology |Tango Therapeutics, Inc.|Last Updated: Oct 1, 2021

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02746952Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic LeukaemiaPHASE1 COMPLETED 25 — — Aug 1, 2016Jul 28, 2020Oct 1, 20219 United States, France +2
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Study Endpoints
Primary Endpoints
Dose escalation part: Dose Limiting Toxicities (DLTs) occurence. Dose expansion part: AE throughout the study.
Dose Escalation: Up to day 28 post first UCART19 infusion. Dose Expansion: From inclusion to Month 12
Secondary Endpoints
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
From inclusion to Month 12
Objective Remission Rate
At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12
Duration of remission
From the time that response criteria are first met until the date of progression or death (whatever the reason of death), whichever occurs first, assessed up to Month 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
UCART19EXPERIMENTAL -
Interventions
NameTypeDescription
UCART19BIOLOGICAL -
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Eligibility Criteria
Age Range16 Years — 69 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Male or female participant * Age ≥ 16 years * Patient with relapsed or refractory CD19 positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options * Estimated life expectancy ≥ 12 weeks (according to investigator's judgement) * Eastern Coo...

Countries:United StatesFranceJapanUnited Kingdom
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