Trial Outcomes & Findings for MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma (NCT NCT04552743)

Last Updated: 2022-09-10

Results Overview

The study Primary Objective is to assess the efficacy of hematopoietic stem cells (HSC) mobilization with MGTA-145 in combination with plerixafor in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). The primary outcome was assessed as the number of participants for whom 2.0 x 10e6 CD34+ HSC cells/kg could be collected in 1 or 2 apheresis harvests, after mobilization with MGTA-145 and Plerixafor. The outcome is reported as the number of participants who achieved this level of HSC cells, a number without dispersion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

2 days

Results posted on

2022-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	MGTA-145 and Plerixafor HSC Mobilization Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MGTA-145 and Plerixafor HSC Mobilization n=25 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	62.2 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=25 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests	22 Participants

SECONDARY outcome

Timeframe: 2 days

The study Primary Objective is to assess the efficacy of hematopoietic stem cells (HSC) mobilization with MGTA-145 in combination with plerixafor in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). Other secondary outcomes were assessed as the number of participants for whom 2.0 or 4.0 x 10e6 CD34+ HSC cells/kg could be collected in the Day 1 apheresis harvest only, and for whom the total yield ≥ 4.0 or ≥ 6.0 x 106 CD34+ cells/kg. The outcome is reported as the number of participants who achieved these levels of HSC cells, a number without dispersion.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=25 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product ≥ 2.0 x 10e6 CD34+ cells/kg on Day 1	17 Participants
Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product ≥ 4.0 x 10e6 CD34+ cells/kg on Day 1	9 Participants
Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product Total ≥ 4.0 x 10e6 CD34+ cells/kg	17 Participants
Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product Total ≥ 6.0 x 10e6 CD34+ cells/kg	10 Participants

SECONDARY outcome

Timeframe: 15 days

Neutrophil engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to neutrophil engraftment is defined as the number of days from the day of stem cell infusion to the 1st day of 3 consecutive days that absolute neutrophil count (ANC) is ≥ 0.5 x 10e9/L. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days with full range.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=25 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Time To Neutrophil Engraftment	12 days Interval 11.0 to 15.0

SECONDARY outcome

Timeframe: 100 days

Population: This outcome is limited to participants that proceeded to the hematopoietic stem cell (HSC) infusion procedure, and with successful neutrophil engraftment.

Maintenance of successful engraftment after initial engraftment is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants with successful neutrophil engraftment \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\], the outcome is reported as the number of participants that had maintained successful graft status \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\] at 30 days and 100 days after the infusion. The outcome is a number without dispersion.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=19 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Maintenance of Neutrophil Engraftment [Absolute Neutrophil Count (ANC) ≥ 0.5 x 10e9/L] ANC ≥ 0.5 x 10e9/L at 30 days	19 Participants
Maintenance of Neutrophil Engraftment [Absolute Neutrophil Count (ANC) ≥ 0.5 x 10e9/L] ANC ≥ 0.5 x 10e9/L at 100 days	19 Participants

SECONDARY outcome

Timeframe: 33 days

Population: This outcome is limited to participants that proceeded to the hematopoietic stem cell (HSC) infusion procedure.

Platelet engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to platelet engraftment ≥ 20 x 10e9/L is defined as the 1st day of 2 consecutive days that platelet count is ≥ 20 x 10e9/L, without transfusion in the prior 7 days. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days with full range.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=19 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Time To Platelet Engraftment ≥ 20 x 10e9/L	18 days Interval 15.0 to 33.0

SECONDARY outcome

Timeframe: 44 days

Population: This outcome is limited to participants that proceeded to the hematopoietic stem cell (HSC) infusion procedure.

Platelet engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to platelet engraftment ≥ 50 x 10e9/L s defined as the 1st day that platelet count is ≥ 50 x 10e9/L, without transfusion in the prior 48 hours. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days, with full range.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=19 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Time To Platelet Engraftment ≥ 50 x 10e9/L	20 days Interval 13.0 to 34.0

SECONDARY outcome

Timeframe: 7 days after mobilization procedure

Infusion-related toxicities are adverse events considered at least possibly-related to the study treatments MGTA-145, assessed from Baseline to 7 days after mobilization. The outcome is reported as a listing of the preferred terms for the "at least possibly-related" adverse events, with outcome being the number of adverse events of that preferred term. The outcome is a listing of numbers without dispersion.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=25 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Infusion-related Toxicities Pain	11 adverse events
Infusion-related Toxicities Aspartate/alanine aminotransferase increase	1 adverse events
Infusion-related Toxicities Nausea	2 adverse events
Infusion-related Toxicities Headache	1 adverse events
Infusion-related Toxicities Hyperhidrosis	1 adverse events
Infusion-related Toxicities Low platelet count	2 adverse events
Infusion-related Toxicities Vomiting	1 adverse events
Infusion-related Toxicities Poor Graft Function (beyond 7 days post-mobilization)	1 adverse events

SECONDARY outcome

Timeframe: 100 days after infusion procedure

Population: This outcome is limited to participants that proceeded to the hematopoietic stem cell (HSC) infusion procedure.

Progression-free survival (PFS) is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who remained alive and were without tumor progression, at 100 days after the infusion. The outcome is a number without dispersion.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=19 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Progression-free Survival (PFS)	18 Participants

SECONDARY outcome

Timeframe: 100 days after infusion procedure

Population: This outcome is limited to participants that proceeded to the hematopoietic stem cell (HSC) infusion procedure.

Transplant-related mortality is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who had expired for any reason considered at least possibly related to the transplant / infusion procedure, within 100 days of the infusion. The outcome is a number without dispersion.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=19 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Transplant-related Mortality	0 Participants

SECONDARY outcome

Timeframe: 100 days after infusion procedure

Population: This outcome is limited to participants that proceeded to the hematopoietic stem cell (HSC) infusion procedure.

For participants that received the HSC infusion, the outcome is reported as the number of participants who had expired for any reason except disease relapse/progression, within 100 days of the infusion. The outcome is a number without dispersion.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=19 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Non-relapse-related Mortality	0 Participants

SECONDARY outcome

Timeframe: 100 days after infusion procedure

Population: This outcome is limited to participants that proceeded to the hematopoietic stem cell (HSC) infusion procedure.

Only patients proceeding with upfront transplant will be assessed. Overall survival is defined as duration from start of the ASCT to death (regardless of cause of death). This will be assessed from start of transplant and OS rates will be reported at day100 following transplant in patients undergoing upfront transplant. Overall survival (OS) is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who remained alive at 100 days after the infusion. The outcome is a number without dispersion.

Outcome measures

Outcome measures
Measure	MGTA-145 and Plerixafor HSC Mobilization n=19 Participants Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Overall Survival (OS)	19 Participants

Adverse Events

MGTA-145 and Plerixafor HSC Mobilization

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MGTA-145 and Plerixafor HSC Mobilization n=25 participants at risk Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Investigations Platelet count decreased	20.0% 5/25 • Number of events 5 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
General disorders Pain	52.0% 13/25 • Number of events 16 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
General disorders Fatigue	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
General disorders Chills	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Blood and lymphatic system disorders Anemia	12.0% 3/25 • Number of events 5 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Blood and lymphatic system disorders Other - Poor Graft Function (anemia, neutropenia, thrombocytopenia)	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Gastrointestinal disorders Oral dysesthesia	8.0% 2/25 • Number of events 2 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Gastrointestinal disorders Nausea	24.0% 6/25 • Number of events 6 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Gastrointestinal disorders Vomiting	8.0% 2/25 • Number of events 2 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Gastrointestinal disorders Diarrhea	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Gastrointestinal disorders Constipation	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Investigations Aspartate aminotransferase increased	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Investigations Alanine aminotransferase increased	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Metabolism and nutrition disorders Hypocalcemia	20.0% 5/25 • Number of events 6 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Metabolism and nutrition disorders Hypokalemia	12.0% 3/25 • Number of events 3 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Nervous system disorders Headache	8.0% 2/25 • Number of events 2 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Nervous system disorders Paresthesia	28.0% 7/25 • Number of events 8 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Psychiatric disorders Insomnia	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Renal and urinary disorders Urinary frequency	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.
Vascular disorders Hot flashes	4.0% 1/25 • Number of events 1 • Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.

Additional Information

Khanh Nguyen

Stanford Medicine at Stanford University

Phone: 650-721-2372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place