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UCART20x22

Phase 1

B-cell Non-Hodgkin Lymphoma (B-NHL) | Monoclonal antibody | Oncology |Cellectis S.A.|Last Updated: Aug 24, 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 Enrollment80
FDA Designations
ORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05607420Study Evaluating UCART20x22 in B-Cell Non-Hodgkin LymphomaPHASE1 RECRUITING 80 — — Nov 1, 2022Aug 1, 2027Aug 24, 202510 United States, France +1
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Study Endpoints
Primary Endpoints
Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]
From study entry through month 12

Incidence, nature and severity of adverse events and serious adverse events in relation to UCART20x22 and/or lymphodepletion

Dose finding part: Occurrence of Dose Limiting Toxicities (DLTs)
Up to Day 28 post UCART20x22 infusion
Secondary Endpoints
Investigator assessed overall response rate (ORR) according to Lugano Response Criteria for Malignant Lymphoma
At Day 28, Day 84, Month 6, Month 9, Month 12
Duration of Response
From achievement of the initial response to disease relapse/progression or death from any cause, assessed up to Month 12
Progression-free survival (PFS)
From the first day of any study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose finding partEXPERIMENTALUCART20x22 tested at several dose levels until the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) is identified. Dose expansion part: UCART20x22 administered at the RP2D determined during the dose finding part
Interventions
NameTypeDescription
UCART20x22BIOLOGICALAllogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen
CLLS52BIOLOGICALA monoclonal antibody that recognizes a CD52 antigen
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Relapsed or refractory (R/R) mature B-NHL per 2016 WHO criteria and positive for CD20 and/or CD22 * Subjects with NHL subtypes defined by WHO: * Dose-Finding Part: R/R mature B-NHL (except chronic lymphoc...

Countries:United StatesFranceSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05607420primaryCompletionDate: changed
LOWMay 24, 2026NCT05607420studyFirstPostDate: changed