Relapsed/refractory CD7+ T-cell Acute Lymphoblastic Leukemia/Lymphoma
Conditions
Brief summary
Phase I primary end-points • To evaluate the safety of the infusion of CD7-CART01 at 2 different escalating doses (1.0 x 106 and 3.0 x 106 cells/kg recipient total body weight of CAR+ T cells) and establish the dose-limiting toxicity (DLT) of the cellular product. DLT will be defined as any of the following that is not pre-existing, due to infection or to underlying malignancy, occurring in the first 28 days after infusion, and that may be considered possibly, probably or definitely related to t, Phase II primary end-points 1. To assess the antitumor effect of CD7-CART01 at day 28 post-infusion by determining BM, PB and CSF morphological response and MRD. In particular, the primary end-point will be the proportion of patients achieving either morphological complete remission (CR) or CR with incomplete blood count recovery (CRi) and with minimal residual disease (MRD) negativity at day 28 (defined as a value < 1x10-4).
Detailed description
Phase I and II secondary end-points: 1. To confirm the safety of the approach, using the recommended dose defined during the Phase I portion of the study. 2. To assess the Overall Response Rate (ORR) at day 28, which includes MRD-negative CR, CR and CR with incomplete blood count recovery (CRi). Only for patients with LL, the percentage of responders will be defined by a reduction of the tumor masses >35% at day+33 and blasts percentage <5% in the BM and absence of blasts in the CSF.
Interventions
Sponsors
Ospedale Pediatrico Bambino Gesu'
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I primary end-points • To evaluate the safety of the infusion of CD7-CART01 at 2 different escalating doses (1.0 x 106 and 3.0 x 106 cells/kg recipient total body weight of CAR+ T cells) and establish the dose-limiting toxicity (DLT) of the cellular product. DLT will be defined as any of the following that is not pre-existing, due to infection or to underlying malignancy, occurring in the first 28 days after infusion, and that may be considered possibly, probably or definitely related to t, Phase II primary end-points 1. To assess the antitumor effect of CD7-CART01 at day 28 post-infusion by determining BM, PB and CSF morphological response and MRD. In particular, the primary end-point will be the proportion of patients achieving either morphological complete remission (CR) or CR with incomplete blood count recovery (CRi) and with minimal residual disease (MRD) negativity at day 28 (defined as a value < 1x10-4). | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I and II secondary end-points: 1. To confirm the safety of the approach, using the recommended dose defined during the Phase I portion of the study. 2. To assess the Overall Response Rate (ORR) at day 28, which includes MRD-negative CR, CR and CR with incomplete blood count recovery (CRi). Only for patients with LL, the percentage of responders will be defined by a reduction of the tumor masses >35% at day+33 and blasts percentage <5% in the BM and absence of blasts in the CSF. | — |
Countries
Italy
Outcome results
None listed