Refractory/relapsed B-NHL, Relapsed or refractory CD19 positive B cell malignancies (pediatric acute lymphatic leukemia [ALL], aggressive NHL), Relapsed or refractory CD19 positive B cell malignancies (adult ALL, adult NHL/chronic lymphatic leukemia [CLL])
Conditions
Brief summary
Recommended dose of MB-CART19.1, determined on the basis of the maximum tolerated dose (MTD), defined as the highest dose level of the two to three dose levels tested at which <33% of patients experience DLT until day 28 after infusion of MB-CART19.1, and on the basis of the safety and efficacy data., Safety and toxicity assessment of MB-CART19.1 per adverse events (AE) reporting classified according to CTCAE version 5.0. defined by <33% of patients experiencing DLT, or maximal administered dose.
Detailed description
Overall incidence and severity of adverse events, Response to treatment: o Overall response rate (ORR) in ALL patients defined as the rate of complete remission (CR, CRh) on day 28; o Rate of ALL patients achieving MRD response (<10-4); o ORR in NHL patients is defined as the rate of overall response (CR or PR) on day 28 and at month 3 in patients not in CR on day 28, Occurrence of B cell depletion, Phenotype and persistence of MB-CART19.1, Further safety assessments., Proportion of patients meeting the inclusion criteria and none of the exclusion criteria for who an autologous MB-CART19.1 product can be generated;, Rate of ALL patients achieving MRD response (<10-4), Duration of response, relapse rate and time to relapse;, Disease-free and overall survival at 1 year after adoptive immunotherapy with MB-CART19.1 in patients not receiving alloSCT;
Interventions
DRUGMB-CART19.1
Sponsors
Miltenyi Biomedicine GmbH
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended dose of MB-CART19.1, determined on the basis of the maximum tolerated dose (MTD), defined as the highest dose level of the two to three dose levels tested at which <33% of patients experience DLT until day 28 after infusion of MB-CART19.1, and on the basis of the safety and efficacy data., Safety and toxicity assessment of MB-CART19.1 per adverse events (AE) reporting classified according to CTCAE version 5.0. defined by <33% of patients experiencing DLT, or maximal administered dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall incidence and severity of adverse events, Response to treatment: o Overall response rate (ORR) in ALL patients defined as the rate of complete remission (CR, CRh) on day 28; o Rate of ALL patients achieving MRD response (<10-4); o ORR in NHL patients is defined as the rate of overall response (CR or PR) on day 28 and at month 3 in patients not in CR on day 28, Occurrence of B cell depletion, Phenotype and persistence of MB-CART19.1, Further safety assessments., Proportion of patients meeting the inclusion criteria and none of the exclusion criteria for who an autologous MB-CART19.1 product can be generated;, Rate of ALL patients achieving MRD response (<10-4), Duration of response, relapse rate and time to relapse;, Disease-free and overall survival at 1 year after adoptive immunotherapy with MB-CART19.1 in patients not receiving alloSCT; | — |
Countries
Germany
Outcome results
None listed