Trial Outcomes & Findings for MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies (NCT NCT04762875)
NCT ID: NCT04762875
Last Updated: 2024-11-06
Results Overview
Number of subjects with adequate number of hematopoietic stem cells (≥ 2.0 x 10\^6 CD34+ cells/kg) in one apheresis setting.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 2 days
Results posted on
2024-11-06
Participant Flow
Participant milestones
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
Donor population
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
Subjects Transplanted With Plerixafor + MGTA-145 Mobilized Product
Transplant recipient after donors mobilized with single-dose MGTA-145 plus plerixafor
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=4 Participants
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
Subjects Transplanted With Plerixafor + MGTA-145 Mobilized Product
n=3 Participants
Transplant recipient after donors mobilized with single-dose MGTA-145 plus plerixafor
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
61 years
n=7 Participants
|
45 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Weight
|
73.7 kg
n=5 Participants
|
81 kg
n=7 Participants
|
77 kg
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 daysNumber of subjects with adequate number of hematopoietic stem cells (≥ 2.0 x 10\^6 CD34+ cells/kg) in one apheresis setting.
Outcome measures
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=4 Participants
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
|---|---|
|
HSC Yield in Apheresis Product
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 daysTo determine the proportion of donors whose cells can be successfully mobilized and collected with a target CD34+ cell dose of at least 4.0 x 10\^6 CD34+ cells/kg actual recipient weight in one apheresis collection
Outcome measures
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=4 Participants
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
|---|---|
|
HSC Yield in Apheresis Product
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline though day 180To ascertain the incidence of adverse events (AEs) before and during apheresis experienced by donors receiving MGTA-145 + plerixafor
Outcome measures
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=4 Participants
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
|---|---|
|
Adverse Events Experienced by Donors
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 28The proportion of participants with primary and secondary graft failure after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
Outcome measures
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=3 Participants
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
|---|---|
|
Graft Durability
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 100To determine the incidence of acute and chronic graft versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
Outcome measures
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=3 Participants
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
|---|---|
|
Graft-versus Host Disease (GVHD)
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 100To determine the proportion of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
Outcome measures
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=3 Participants
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
|---|---|
|
Treatment-related Mortality
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 100To determine the probability of overall survival after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
Outcome measures
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=3 Participants
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
|---|---|
|
Overall Survival
|
2 Participants
|
Adverse Events
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Subjects Transplanted With Plerixafor + MGTA-145 Mobilized Product
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=4 participants at risk
Donor population
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
Subjects Transplanted With Plerixafor + MGTA-145 Mobilized Product
n=3 participants at risk
Transplant recipient after donors mobilized with single-dose MGTA-145 plus plerixafor
|
|---|---|---|
|
Blood and lymphatic system disorders
Secondary Graft Loss
|
0.00%
0/4 • 6 months
|
33.3%
1/3 • 6 months
|
|
Gastrointestinal disorders
Upper GI Hemorrhage
|
0.00%
0/4 • 6 months
|
33.3%
1/3 • 6 months
|
|
Infections and infestations
Aspergillus pneumonia
|
0.00%
0/4 • 6 months
|
33.3%
1/3 • 6 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • 6 months
|
33.3%
1/3 • 6 months
|
Other adverse events
| Measure |
Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis
n=4 participants at risk
Donor population
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
MGTA-145: MGTA-145 will be be administered as an IV infusion
Plerixafor: 240 µg/kg subcutaneously
|
Subjects Transplanted With Plerixafor + MGTA-145 Mobilized Product
n=3 participants at risk
Transplant recipient after donors mobilized with single-dose MGTA-145 plus plerixafor
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Chills
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Fever
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
General disorders
Pain - arm
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • 6 months
|
33.3%
1/3 • 6 months
|
|
Investigations
Platelet count decreased
|
75.0%
3/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Nervous system disorders
Dysesthesia
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Nervous system disorders
Mild face tingling
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/4 • 6 months
|
33.3%
1/3 • 6 months
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • 6 months
|
0.00%
0/3 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place