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-DARIC33

Phase 1

Acute Myeloid Leukemia | Monoclonal antibody | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Dec 23, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05105152PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AMLPHASE1 RECRUITING 18Nov 29, 2021Jan 31, 2041Dec 23, 20251 United States
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Study Endpoints
Primary Endpoints
Adverse events associated with SC-DARIC33 cell product infusions will be assessed
28 days post-infusion

The type, frequency, severity, and duration of adverse events will be summarized

Ability to successfully manufacture SC-DARIC33
28 days

Measure of the number of successfully manufactured SC-DARIC33 products

Secondary Endpoints
Acute Myeloid Leukemia response to SC-DARIC in subjects with relapsed or refractory CD33+ myeloid leukemia will be assessed
28 days post-infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DARIC-33EXPERIMENTAL -
Interventions
NameTypeDescription
SC-DARIC33BIOLOGICALInfusion with SC-DARIC33 followed by intermittent oral rapamycin administration
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Eligibility Criteria
Age RangeN/A — 30 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subject age ≤ 30 years. The first three enrolled subjects must be ≥ 18 years of age. 2. AML that expresses CD33 by flow cytometry and meets one of the below definitions: 1. For subjects who have previously received an allogeneic HCT, any evidence of AML re-emergence post ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05105152studyFirstPostDate: changed