CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL

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).

Trial Details

NCT ID
NCT06064903
Phase
PHASE1 / PHASE2
Sponsor
Bambino Gesù Hospital and Research Institute
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • CD7-CART01
Locations (sample)
  • Rome, Rome, Italy|41.89193,12.51133

Key Eligibility Criteria

  • Diagnosis of CD7 expressing (\> 98% CD7 expression on blast cells) T-ALL or LL and one of the following:
  • Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement (MRD \>1% in 2 consecutive determinat…
  • 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 …
  • 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;

For full eligibility, visit ClinicalTrials.gov.

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