Dose-escalating Phase I Trial With GEM333 in Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03516760|
Recruitment Status : Active, not recruiting
First Posted : May 4, 2018
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Relapsed AML Refractory AML||Drug: GEM333||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Dose escalation scheme; Single patient cohorts on the first three dose levels, 3+3 afterwards.|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM333, a CD33 Targeted Bispecific Antibody Engaging T-cells, in Relapsed or Refractory Acute Myeloid Leukemia|
|Actual Study Start Date :||April 11, 2018|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
application of GEM333, a CD33 targeted bispecific antibody engaging T-cells
infusion of GEM333; administered intravenously and continuously over 10 days
- Maximum tolerated dose (MTD) [ Time Frame: End of Treatment (EOT) +8 days resp. +28 days (DLT period) ]MTD is the previous dose level of the cohort where a DLT is observed in at least wo subjects.
- Incidence of dose limiting toxicity (DLT) [ Time Frame: End of Treatment (EOT) +8 days resp. +28 days ]Dose Limiting Toxicity is defined as any event at least possibly related to IMP (complete definition provided protocol)
- Incidence and intensity of adverse events graded according to CTCAE V4.03 [ Time Frame: End of Treatment (EOT) +8 days resp. +28 days ]
- Recommended phase 2 dose [ Time Frame: From start of treatment until up to +28 days after last treatment cycle (1 initial cycle + max. 2 additional cycles per patient). Each cycle consists of 10 days treatment plus DLT evaluation period (8 resp. 28 days, depending on blast clearance). ]The RP2D will be determined based on MTD, all available efficacy data, and all available safety data, including information derived from additional treatment cycles.
- Complete remission (CR) [ Time Frame: until two years after start of study medication ]bone marrow blasts < 5%, absence of extramedullary disease, absolute neutrophil count > 1 Gpt/L and platelet count > 100 Gpt/L
- Composite complete remission (CRc) rate [ Time Frame: until two years after start of study medication ]Rate at any time point, defined as the proportion of patients having either CR or CRi
- Partial Remission (PR) [ Time Frame: until two years after start of study medication ]All hematological criteria for CR with bone marrow blasts 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50 %.
- Disease stabilization (DS) [ Time Frame: until two years after start of study medication ]Reduction of blast percentage by 25% compared to baseline without normalization of peripheral blood counts to levels not qualifying for PR or CR
- Best response rate [ Time Frame: until two years after start of study medication ]Defined as the best observed response at any time point during observational period.
- Duration of CRc [ Time Frame: until two years after start of study medication ]Defined as the number of days between the date of CR/CRi achievement and the date of the last assessment confirming CR/CRi
- Duration of PR [ Time Frame: until two years after start of study medication ]Defined as the number of days between the date of PR achievement and the date of the last assessment confirming PR.
- Progression free survival (PFS) [ Time Frame: until two years after start of study medication ]Is defined as the time from first treatment with GEM333 until disease progression or death from any cause
- Overall survival [ Time Frame: until two years after start of study medication ]Defined as the number of days between the first study drug administration and death from any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516760
|Mannheim, Baden-Württemberg, Germany, 68167|
|Klinikum rechts der Isar|
|München, Bayern, Germany, 81675|
|Würzburg, Bayern, Germany, 97080|
|Frankfurt am Main, Hessen, Germany, 60590|
|Marburg, Hessen, Germany, 35039|
|Dresden, Sachsen, Germany, 01307|
|Berlin, Germany, 13353|
|Principal Investigator:||Martin Wermke, MD||Universitätsklinikum Carl Gustav Carus Dresden|