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Open-label dose-finding and dose-expansion study to evaluate the safety, expansion, persistence, and clinical activity of UCART20x22 in subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL)

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501607-27-00
Enrollment
48
Registered
2023-03-08
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory B-cell Non-Hodgkin lymphoma

Brief summary

For the dose-finding part: Incidence, nature and severity of AEs and SAEs Proportion of subjects in each dose-level cohort with DLT during the DLT Observation Period For the dose-expansion part: Incidence, nature, and severity of AEs and SAEs during the dose-expansion part Incidence, nature, and severity of AEs and SAEs associated with LD in dose-expansion part

Detailed description

: For the dose-finding and dose-expansion parts: Investigator assessed ORR according to Lugano response criteria. PFS, OS, and DoR Incidence, nature, and severity of AEs and SAEs associated with LD, associated antitumor activity, and corresponding host T-cell recovery and CAR T-cell expansion Quantitation of alemtuzumab levels in serum, evaluation of alemtuzumab PK parameters, TBNK panel and lymphocyte count

Interventions

DRUGPROLEUKIN
DRUG18x106 UI polvo para solución inyectable o para perfusión
DRUGUCART20X22
DRUGLEMTRADA 12 mg concentrate for solution for infusion
DRUGFludarabina Teva 25 mg/ml concentrado para solución para perfusión o inyección EFG
DRUGFLUDARA 50 mg
DRUGpoudre pour solution injectable ou perfusion
DRUGGenoxal 1.000 mg polvo para solución inyectable y para perfusión
DRUGPROLEUKIN 18 millions U.I.
DRUGpoudre pour solution injectable
DRUGENDOXAN 1000 mg
DRUGCLLS52
DRUGProleukin 18 x 106 UI Polvere per soluzione iniettabile o per infusione
DRUGProleukin® S 18 x 10 6 IE Pulver zur Herstellung einer Injektionslösung oder Infusionslösung

Sponsors

Cellectis
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
For the dose-finding part: Incidence, nature and severity of AEs and SAEs Proportion of subjects in each dose-level cohort with DLT during the DLT Observation Period For the dose-expansion part: Incidence, nature, and severity of AEs and SAEs during the dose-expansion part Incidence, nature, and severity of AEs and SAEs associated with LD in dose-expansion part—

Secondary

MeasureTime frame
: For the dose-finding and dose-expansion parts: Investigator assessed ORR according to Lugano response criteria. PFS, OS, and DoR Incidence, nature, and severity of AEs and SAEs associated with LD, associated antitumor activity, and corresponding host T-cell recovery and CAR T-cell expansion Quantitation of alemtuzumab levels in serum, evaluation of alemtuzumab PK parameters, TBNK panel and lymphocyte count—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026