Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence

Tisagenlecleucel (CTL019) is an anti-CD19 autologous Chimeric Antigen Receptor (CAR) T-cell therapy, which has shown dramatic early results in advanced ALLs. Early loss of B-cell aplasia (recovery of B-cells in marrow/ peripheral blood within 6 months after infusion), a marker of the loss or non-functionality of the CAR T-cells, is associated to a very high risk of relapse. A reinfusion of CTL019, even after Fludarabine-Cyclophosphamide reconditioning, frequently fails to induce further expansion as observed in UPENN studies and in the Robert Debré Hospital experience. Non-persistence of CAR

Trial Details

NCT ID
NCT05310591
Phase
PHASE1 / PHASE2
Sponsor
Assistance Publique - Hôpitaux de Paris
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) )
  • Nivolumab starting at day -1
Locations (sample)
  • Bordeaux, France|44.84124,-0.58046
  • Lille, France|50.63391,3.05512
  • Lyon, France|45.74906,4.84789
  • Lyon, France|45.74906,4.84789
  • Lyon, France|45.74906,4.84789

Key Eligibility Criteria

  • Patients aged from 1 to 25 years (pediatric and young adults) with a history of CD19+ relapsed or refractory B-ALL (any relapse after HSCT, 2nd rel…
  • Patient must have a second tisagenlecleucel (Kymriah ®) product available
  • Cohort 1: previously treated by tisagenlecleucel (Kymriah ®), and who present an early loss of B-cell aplasia defined by blood B lymphocytes \< 10 …
  • Cohort 2: previously treated by tisagenlecleucel (Kymriah ®), who present a loss of B-cell aplasia defined by blood B lymphocytes \< 10 /mm3 and/ o…

For full eligibility, visit ClinicalTrials.gov.

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