Study of CD19 Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a Phase I clinical study evaluating the safety and maximum tolerated dose of a novel CAR T-cell product: allogeneic memory (CD45RA- negative) T-cells expressing a CD19-specific CAR 41BBz (CD19-CAR.CD45RA- negative T-cells) for the treatment of patients ≤ 21 years old with relapsed and/ or refractory CD19-positive leukemia. Primary Objective To determine the maximum tolerated dose (MTD) and characterize the safety profile and dose-limiting toxicities (DLTs) of treatment with allogeneic CD19-CAR.CD45RA-negative T-cells in pediatric, adolescent and young adult patients ≤ 21 years of age, with relapsed and/or refractory CD19-positive leukemia. Secondary Objectives * To evaluate the anti-leukemic activity of allogeneic CD19-CAR.CD45RA-negative T-cells. * To determine rates and severity of graft-versus-host-disease (GVHD) after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells. Exploratory Objectives * To study the expansion, persistence and phenotype of allogeneic CD19-CAR.CD45RA-negative T-cells. * To characterize the cytokine profile in the peripheral blood and CSF after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells. * To assess whether allogeneic CD19-CAR.CD45RA-negative T-cells acquire functional versus exhaustion-associated epigenetic programs. * To determine immune reconstitution post treatment, and the clonal structure and endogenous repertoire of allogeneic CD19-CAR.CD45RA-negative T-cells and relate inferred specificity to CAR response profiles. * To characterize incidence and mechanisms of relapse post-therapy with allogeneic CD19-CAR.CD45RA-negative T-cells.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek do 21 lat
- •Rozpoznana białaczka limfoblastyczna (ALL), która powróciła po leczeniu lub nie reaguje na standardowe leczenie
- •Choroba CD19-dodatnia (określony typ białaczki)
- •Dostęp do dawcy komórek - krewnego o zgodnym typie tkanek
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu
✗ Disqualifies
- •Wcześniejsza nieudana próba pobrania własnych komórek pacjenta
- •Wcześniejsze niepowodzenie w wytworzeniu własnych komórek CAR-T
- •Ciężkie problemy zdrowotne uniemożliwiające bezpieczne przeprowadzenie procedury
- •Zbyt mała masa ciała lub zbyt niskie liczby komórek uodpornienia
- •Bardzo szybko postępująca choroba, która nie pozwala na czekanie na przygotowanie leku
Simplified criteria — AI translation
Trial details
- Maximum age
- 21 Years
- Last updated (source)
- August 31, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
St. Jude Children's Research Hospital
Memphis, United States
Trial contact
Aimee C. Talleur, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/1/2026.
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