CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-25
SponsorBambino Gesù Hospital and Research Institute
About this trial
The main purpose of this study is to evaluate the safety, to establish the recommended dose, and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL).
Eligibility criteria
Qualifiers
Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement (MRD >1% in 2 consecutive determinations or evidence of morphological relapse, i.e. >5% blasts in BM);
Relapse after allogeneic HSCT, if at least 100 days post-transplant, if there is no evidence of active GVHD and if the patient is no longer taking immunosuppressive agents for at least 30 days prior to enrollment;
CNS disease as defined as > 5 WBCs/mcL in CSF with morphological/flow-cytometry evidence of blasts or biopsy proven recurrence in the eye or brain;
Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites;
Disqualifiers
Severe, uncontrolled active intercurrent infections.
HIV, or active HCV and/or HBV infection.
Blast contamination in peripheral blood >5%, by flow-cytometry, at the time of leukapheresis collection.
Systemic steroids (at a dose equivalent to or greater than 2 mg/kg prednisone) in the 2 weeks before apheresis collection. Recent or current use of inhaled/topical/non-absorbable steroids is not exclusionary
Trial design
Treatments tested in this trial
- CD7-CART01
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov