CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL
Italy26 participantsStarted 2024-04-21
Plain-language summary
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).
Who can participate
Age range6 Months – 25 Years
SexALL
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Inclusion 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 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;
✓. Refractory disease, defined as MRD ≥ 1% or \<1% but persistently positive (i.e. a positive MRD value confirmed by PCR at 2 subsequent evaluations performed at least 2 weeks apart), at the end of consolidation blocks in newly diagnosed patients;
✓. Age: 6 months - 25 years.
✓. Adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis.
Exclusion criteria
✕. Severe, uncontrolled active intercurrent infections.
✕. HIV, or active HCV and/or HBV infection.
What they're measuring
1
Safety (Phase I) and definition of the recommended dose (Phase I)
Timeframe: 28 days
2
Antitumor effect of CD7-CART01 (Phase II)
Timeframe: 28 days
Trial details
NCT IDNCT06064903
SponsorBambino Gesù Hospital and Research Institute
. Blast contamination in peripheral blood \>5%, by flow-cytometry, at the time of leukapheresis collection.
✕. Concurrent or recent prior therapies, before apheresis:
✕. 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
✕. Systemic chemotherapy in the 2 weeks preceding apheresis collection
✕. Nelarabine, daratumomab, clofarabine exposure in the 3 weeks preceding apheresis collection
✕. Anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding apheresis collection