Charité - University clinic, pediatric clinic with focus on oncology and hematology 13353 Berlin (Berlin) GermanyRekrutierend» Google-Maps Ansprechpartner: Annette Kuenkele, Dr. Phone: +49 30 450 616 178 E-Mail: annette.kuenkele@charite.de
Arend von Stackelberg, PD, Dr. Phone: +49 30 450 666 833 E-Mail: arend.stackelberg@charite.de» Ansprechpartner anzeigenUniversity clinic, clinical for children and youth 91054 Erlangen (Bayern) GermanyAktiv, nicht rekrutierend» Google-MapsHautkrebszentrum Universitätsklinikum Erlangen Ulmenweg 18 91054 Erlangen (Bayern) DeutschlandRekrutierend» Google-Maps Ansprechpartner: Andreas Mackensen, Prof.Dr. Phone: 0049 (0)9131 8535 954 E-Mail: andreas.mackensen@uk-erlangen.de
Barbara Ferstl, Dr. Phone: 0049 (0)9131 8543 104 E-Mail: barbara.ferstl@uk-erlangen.de» Ansprechpartner anzeigen
University medicine Goettingen, Clinic of hematology and medical oncology 37075 Göttingen (Niedersachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Justin Hasenkamp, Dr. Phone: +49 55 139 651 82 E-Mail: justin.hasenkamp@med.uni-goettingen.de
Gerald Wulf, Prof., Dr. Phone: +49 55 139 170 577 E-Mail: gerald.wulf@med.uni-goettingen.de» Ansprechpartner anzeigenChildren's Hospital of Dr. von Hauner by Ludwig-Maximilian University 80337 Munich (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Tobias Feuchtinger, Prof., Dr. Phone: +49 89 440 052 759 E-Mail: tobias.feuchtinger@med.uni-muenchen.de
Vera Binder, Dr. Phone: +49 89 440 052 875 E-Mail: vera.binder@med.uni-muenchen.de» Ansprechpartner anzeigenUniversitätsklinikum Münster - Klink für Kinderheilkunde und Jugendmedizin / Pädiatrische Hämatologie und Onkologie 48149 Münster (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Claudia Rössig, Prof. Dr. Phone: 0049 (0)251 83 47 741 E-Mail: rossig@ukmuenster.de
Birgit Burkhardt, PD Dr. Phone: 0049 (0)251 83 52 840 E-Mail: birgit.burkhardt@ukmuenster.de» Ansprechpartner anzeigenUniversitätsklinikum Münster - Medizinische Klinik A / KMT Zentrum 48149 Münster (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Matthias Stelljes, Prof. Dr. Phone: +49 251 83 52801 E-Mail: matthias.stelljes@ukmuenster.de
Jan Henrik Mikesch, Dr. Phone: +49 251 83 52801 E-Mail: jan-henrik.mikesch@ukmuenster.de» Ansprechpartner anzeigenTuebingen University clinic, medical university clinic for internal medicine 72076 Tuebingen (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Wolfgang Bethge, Prof., Dr. Phone: +49 70 712 083 176 E-Mail: wolfgang.bethge@med.uni-tuebingen.de
Christoph Faul, Dr. Phone: +49 70 712 984 087 E-Mail: christoph.faul@med.uni-tuebingen.de» Ansprechpartner anzeigenUniversity clinic for children and youth medicine 72076 Tuebingen (Baden-Württemberg) GermanyAktiv, nicht rekrutierend» Google-MapsUniversity clinic, pediatric hematology and oncology 97070 Würzburg (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Paul-Gerhardt Schlegel, Prof., Dr. Phone: +49 93 120 127 999 E-Mail: schlegel_p@ukw.de
1. Phase I - Determination of the recommended dose of MB-CART19.1 (Time Frame - until day 28 after infusion of MB-CART19.1): Determined on the basis of the maximum tolerated dose (MTD); MTD is defined as the highest dose level at which < 33% of patients experience Dose Limiting Toxicity (DLT). Safety and toxicity assessment of MB-CART19.1 per adverse events (AE) reporting classified according to CTCAE version 5.0
2. Phase II - Determination of the Overall Response Rate (ORR) (Time Frame - 28 days after infusion of MB-CART19.1 (and at month 3 in NHL patients not in CR on day 28)): ORR in ALL patients is defined as the rate of complete remission (CR, CRh); ORR in NHL patients is defined as the rate of overall response (CR or PR)
Secondary outcome:
1. Phase I - Overall incidence and severity of adverse events (Time Frame - throug study completion, an average of 5 years): per adverse events (AE) reporting classified according to CTCAE version 5.0
2. Phase I - Response to treatment for each timepoint (Time Frame - day 28): ORR in ALL (Rate of CR/CRh)
3. Phase I - Response to treatment for each timepoint (Time Frame - day 28, week 12, month 6, 1 year): Rate MRD-negative CR in ALL
4. Phase I - Response to treatment for each timepoint (Time Frame - day 28, patients not in CR on day 28: month 3): ORR in NHL/CLL (Rate of CR/PR)
5. Phase I - Occurence of B-cell depletion (Time Frame - through study completion, an average of 5 years): Circulating B cell numbers
6. Phase I - Phenotype and persistence of MB-CART19.1 (Time Frame - days 2, 7, 10, 14, 28, weeks 8, 12, months 6, 12, 24, 36, 48, 60): Blood samples for determination of persistence/phenotyping of infused MB-CART19.1 will be analysed.
7. Phase II - Overall incidence and severity of adverse events (Time Frame - through study completion, an average of 5 years): per adverse events (AE) reporting classified according to CTCAE version 5.0
8. Phase II - Number of patients with successful MB-CART19.1 production (Time Frame - day 0): Number of patients meeting the inclusion criteria and none of the exclusion criteria for who an autologous MB-CART19.1 product can be generated
9. Phase II - Rate of ALL patients achieving MRD negative CR (Time Frame - day 28, week 12, month 6, 1 year): Rate MRD-negative CR in ALL
10. Phase II - Duration of response (Time Frame - through study completion, an average of 5 years): Determination of response rate
11. Phase II - Disease-free survival (Time Frame - at 1 year after MB-CART19.1 infusion in patients not receiving alloSCT): Determination of survival and relapse
12. Phase II - Occurrence of B cell depletion (Time Frame - days 7, 10, 14, 28, weeks 8, 12, 16, months 6, 8, 10, 12, 24, 36, 48, 60): Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry.
13. Phase II - Phenotype and persistence of MB-CART19.1 (Time Frame - days 2, 7, 10, 14, 28, weeks 8, 12, months 6, 12, 24, 36, 48, 60): Blood samples for determination of persistence/phenotyping of infused MB-CART19.1 will be analysed.
Experimental: Phase I: DL 0: 1x10e5 MB-CART19.1 cells In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD.
Experimental: Phase I: DL 1: 5x10e5 MB-CART19.1 cells Dose evaluation will start in Cohorts 1 and 2 with Dose Level 1. In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD.
Experimental: Phase I: DL 2: 1x10e6 MB-CART19.1 cells Dose evaluation will start in Cohort 3 with Dose Level 2, sparing Dose Level 1. If Dose Level 2 is not tolerated, Dose Level 1 will be tested. In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD.
Experimental: Phase I: DL 3: 3x10e6 MB-CART19.1 cells In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. In Dose Level 3, three additional patients will be treated, if no DLT occurred. Dose Level 0 will be tested only if Dose Level 1 is not tolerable.
Experimental: Phase II - Recommended dose MB-CART19.1 Phase II will evaluate the efficacy and safety in patients treated with the recommended dose in Cohorts 1 to 3, respectively.
MB-CART19.1 (CD19-targeting CAR T cells / Anti-CD19 CAR T cells / ): MB-CART19.1 consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells targeting CD19-positive tumor cells in b cell malignancies
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM)"
Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.
Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!