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MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies
Phase 2 trial testing MGTA-145 in Related Donors Donating PBSC to a Family Member in 7 participants. Terminated before completion.
| Lead sponsor | Ensoma |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 16 June 2021 |
| Primary completion | 14 September 2021 |
| Estimated completion | 14 March 2022 |
| Sites | 8 locations across United States |
Ensoma — full company profile →
Adults 18 to 65, any sex, with Related Donors Donating PBSC to a Family Member or Healthy Donors. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of subjects with adequate number of hematopoietic stem cells (≥ 2.0 x 10\^6 CD34+ cells/kg) in one apheresis setting.
| Group | Value | 95% CI |
|---|---|---|
| Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis | 2 |
To 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
| Group | Value | 95% CI |
|---|---|---|
| Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis | 2 |
To ascertain the incidence of adverse events (AEs) before and during apheresis experienced by donors receiving MGTA-145 + plerixafor
| Group | Value | 95% CI |
|---|---|---|
| Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis | 4 |
The proportion of participants with primary and secondary graft failure after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
| Group | Value | 95% CI |
|---|---|---|
| Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis | 0 |
To determine the incidence of acute and chronic graft versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
| Group | Value | 95% CI |
|---|---|---|
| Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis | 0 |
To determine the proportion of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
| Group | Value | 95% CI |
|---|---|---|
| Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis | 0 |
To determine the probability of overall survival after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
| Group | Value | 95% CI |
|---|---|---|
| Single Dose MGTA-145 Plus Plerixafor Followed by Apheresis | 2 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Single Dose MGTA-145 Plus … | Subjects Transplanted With… |
|---|---|---|---|
| Secondary Graft Loss | Blood and lymphatic system disorders | — | — |
| Upper GI Hemorrhage | Gastrointestinal disorders | — | — |
| Aspergillus pneumonia | Infections and infestations | — | — |
| Septic shock | Infections and infestations | — | — |
| Reaction | System | Single Dose MGTA-145 Plus … | Subjects Transplanted With… |
|---|---|---|---|
| Platelet count decreased | Investigations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Eosinophilia | Blood and lymphatic system disorders | — | — |
| Palpitations | Cardiac disorders | — | — |
| Sinus tachycardia | Cardiac disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — |
| Oral dysesthesia | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Fever | General disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Pain - arm | General disorders | — | — |
| Pharyngitis | Infections and infestations | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Dysesthesia | Nervous system disorders | — | — |
| Mild face tingling | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Pruritis | Skin and subcutaneous tissue disorders | — | — |
| Hypertension | Vascular disorders | — | — |
Most-reported serious reactions: Secondary Graft Loss, Upper GI Hemorrhage, Aspergillus pneumonia, Septic shock.
Data from ClinicalTrials.gov NCT04762875 adverse events section.
This research study tests a new medicine for mobilizing stem cells so they can be collected and used for allogeneic stem cell transplant for treatment of hematological malignancies. MGTA-145, the new medicine, will be given with plerixafor.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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