Table 4.
The major ongoing clinical trials of CAR T-cells for the management of patients with B-ALL.
| Trial | Target | Phase | Nb of Patients | Population | Primary Endpoint |
|---|---|---|---|---|---|
| NCT03876769 | CD19 (tisagenlecleucel) | 2 | 140 | First-line high-risk pediatric and young adult with B-ALL with MRD+ at the end of consolidation | DFS |
| NCT05535855 | CD19 (autologous) | 1 | 14 | MRD positive at CR1 | Frequency of AEs DLTs |
| NCT04690595 | BAFFR (autologous) | 1 | 24 | R/R after at least 2 lines including CD19 targeting treatment | Incidence of AEs |
| NCT04404660 (AUTO1) | CD19 (autologous) | 1–2 | 215 | Adults with R/R B-cell ALL | 1b: frequency of AEs 2: ORR |
| NCT02935257 (ALLCAR19) | CD19 (autologous) | 1 | 60 | Adults with R/R ALL, DLBCL, CLL, FL, MCL | |
| NCT05480449 (huCART19 prodigy) | CD19 humanized (autologous) | 1–2 | 89 | Pediatric population with R/R disease | Safety ORR |
| NCT05613348 (CAR19T2) | CD19 humanized | 1–2 | 70 | Pediatric ALL | ORR MTD AEs |
| NCT04609241 | CD79b | 1 | 72 | Pediatric and adults with R/R ALL or NHL | DLT TEAEs |
| NCT04781634 | CD19/CD22 (autologous) | 1–2 | 40 | Pediatric and adult patients with R/R ALL | AEs ORR |
| NCT04723901 | CD19/CD22 (autologous) | 1–2 | 20 | Young adult and adult with R/R ALL | CR rate |
| NCT05225831 | CD19/CD22 (autologous) | 1 | 100 | Pediatric and adult patients with R/R ALL | AEs CR rate |
| NCT04049383 | CD19/CD20 (autologous) | 1 | 24 | Pediatric and young adults with R/R ALL | AEs |
| NCT04788472 | Sequential CD19 and CD22 (autologous) | 1–2 | 50 | Young adults and adults with R/R Phi+ ALL | DLT Incidence of TEAEs |
| NCT04740203 | Sequential CD19 and CD22 (autologous) | 1–2 | 50 | Young adults and adults with R/R Phi-ALL | DLT Incidence of TEAEs |
| NCT05164042 | CD19 (allogenic) | 1–2 | 20 | Young adults and adults with R/R ALL | CR rate |
| NCT05507827 | CD19/CD22 (allogenic) | 1 | 18 | Adults with R/R ALL | Safety |
| NCT05310591 (CAPTiRALL) | Nivolumab + tisagenlecleucel | 1–2 | 26 | Pediatric and young adults with R/R ALL after loss of persistence | % of pts with limiting toxicity Efficacy |
| NCT05418088 | CD19/CD20/CD22 (autologous) | 1 | 36 | R/R B-cell malignancies including ALL | Recommended dose for phase 2 |
DLTs: dose-limiting toxicities; AEs: adverse events; CR1: first complete remission; MRD: minimal residual disease; DFS: disease-free survival; R/R: relapsed and/or refractory; B-ALL: B-cell acute lymphoblastic leukemia; CR: complete remission; ORR: objective response rate; NHL: non-Hodgkin lymphoma; DLBCL: diffuse large B-cell lymphoma; CLL: chronic lymphocytic leukemia; FL: follicular lymphoma; MCL: mantle cell lymphoma; MTD: maximum tolerated dose; TEAEs: treatment-emergent adverse events.