Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06508931 | Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms | PHASE2 | RECRUITING | 31 | — | — | Aug 4, 2025 | Dec 31, 2029 | May 5, 2026 | 5 | France, Germany +2 |
The primary efficacy outcome of this study is BORR, defined as the proportion of subjects with at least one partial response (PR) or complete response (CR) from MB-CART2019.1 infusion until progressive disease (PD), start of new anti-lymphoma therapy, lost to follow-up or death, whichever occurs first.
The primary safety outcome of this study is to evaluate the incidence, type, frequency, and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI) associated with the study product.
| Arm | Type | Description |
|---|---|---|
| zamtocabtagene autoleucel (MB-CART2019.1) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| zamtocabtagene autoleucel (MB-CART2019.1) | DRUG | Tandem CD20-CD19-directed non-cryopreserved CAR-T cell therapy. |
Inclusion Criteria: 1. Is able to provide age-appropriate assent/consent (as applicable, according to local legislation) and/or have a guardian able to provide consent signed and dated by the parent(s) or by subject's legal guardian before conduct of any study-specific procedures. 2. Has histologic...