MGTA-145

MGTA-145 or GROβT, a CXCR2 agonist, has shown promising activity for hematopoietic stem cell (HSC) mobilization with plerixafor in pre-clinical studies and healthy volunteers...Lenalidomide and anti-CD38 antibody were part of induction therapy in 92% (n = 23) and 24% (n = 6) of patients, respectively...74% (17 of 23) of grafts with this regimen were minimal residual disease negative by next generation flow cytometry. Graft composition for HSCs and immune cells were similar to a contemporaneous cohort mobilized with G-CSF and plerixafor.

Participants must have a documented diagnosis of SCA, have a hydroxyurea washout period, and have adequate white blood cell counts and cardiopulmonary, renal, and liver function. Core exploratory endpoints include characterization of the phenotype and function of cells collected by apheresis and assessment of the gene-modifying potential of mobilized CD34+ cells. The results of this trial will establish if MGTA-145 with plerixafor will rapidly and safely mobilize robust numbers of high-quality SCs for HSCT in SCA.

P2, N=25, Completed, Surbhi Sidana, MD | Active, not recruiting --> Completed

P2, N=7, Terminated, Magenta Therapeutics, Inc. | N=56 --> 7 | Active, not recruiting --> Terminated; This study was voluntarily terminated due to a business decision not to proceed and not due to any safety issue

P2, N=56, Active, not recruiting, Magenta Therapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Apr 2022 | Trial primary completion date: Aug 2022 --> Sep 2021

At last follow-up, 18 patients have completed transplant with MGTA-145 graft, with melphalan 200 mg/m 2 in 15 patients. This is the first study to evaluate the novel G-CSF-free regimen of MGTA-145 + plerixafor for HSC cell mobilization in hematologic cancers. 88% patients met the primary endpoint. The regimen was well tolerated.

Induction therapy was VRD in 68% (17), daratumumab VRD in 24% (6), CyBorD in 8% (2) patients. Median duration of induction was 4 months (3-6) and median lenalidomide exposure was 5 cycles (1-8), with > VGPR in 88% of patients...At last follow-up, 18 patients have completed transplant with MGTA-145 mobilized graft, with melphalan 200 mg/m 2 in 15 (83%) patients... This is the first study to evaluate the novel G-CSF-free regimen of MGTA-145 + plerixafor for HSC cell mobilization & collection for hematologic malignancies. The study cohort was representative of transplant eligible patients with MM, with 88% patients meeting the primary endpoint. The regimen was well tolerated.

P2, N=25, Active, not recruiting, Stanford University | Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2022 --> Jul 2021

Induction therapy was VRD in 7 and daratumumab + VRD in 3 patients; median induction duration: 4 months (3-6) & median lenalidomide exposure: 6 cycles (4-6), with > VGPR in 70%...All 6 patients in the safety cohort have completed transplant with melphalan 200 mg/m2...67% of grafts were minimal residual disease negative with next generation flow cytometry. Conclusion This is the first study to evaluate the novel regimen of MGTA-145 + plerixafor for same day stem cell mobilization & collection in myeloma/hematologic malignancies, with 100% efficacy in interim analysis and the first to demonstrate successful engraftment in patients with cells collected with this GCSF free regimen.

P2, N=56, Recruiting, Magenta Therapeutics, Inc.

P2, N=25, Recruiting, Stanford University | Not yet recruiting --> Recruiting | Initiation date: Mar 2021 --> Oct 2020 | Trial primary completion date: Jun 2022 --> Mar 2022

P2, N=25, Not yet recruiting, Stanford University