This study is testing whether giving people with ALS specially matched immune cells called B cells from a related donor is safe. Up to 10 participants will each receive two B cell infusions at least 60 days apart. The main goals are to watch closely for side effects, see whether the participant's immune system rejects the donor cells, and determine whether this treatment should be studied further in people with ALS. The first three participants will receive the infusions in the hospital with extra safety spacing between participants; if those infusions appear safe, the remaining participants may receive them in an outpatient setting.
Confirmed diagnosis of ALS that meets the revised El Escorial criteria for probable lab-supported, probable, or definite ALS.
Age 18-70 years.
Vital capacity of >65%.
ALSFRS-R score of >30.
Unable or unwilling to comply with protocol requirements.
Known current or history of recurrent bacterial, viral, fungal, mycobacterial, or other opportunistic infection.
Use of tofersen (Qalsody).
Use of Rituximab (Rituxan), Ocrelizumab (Ocrevus), Ofatumumab (Kesimpta, Arzerra), Epratuzumab (LymphoCide), Belimumab (Benlysta), MEDI-551, or other anti-CD20, anti-CD19, or anti-CD22 antibodies.
Single group
B cell infusion
Biological/Vaccineinfusion of haploidentical donor CD19+ B cells
Infusion associated adverse events of special interest
Safety and tolerability of up to 2 infusions of donor B cells at individual doses of between 2.0 x 10\^8 and 1.0 x 10\^9 donor B cells defined by: * Incidence of all AEs, as defined for the 30-day time point, at 60 days. * Incidence of Treatment Emergent Serious Adverse Events (TE-SAEs) at 30 days defined as the composite of graft-versus-host disease, other persistent immunologic abnormalities, bleeding disorders, stroke, myocardial infarction, or death.
Evidence of host rejection of infused cells
Donor cell rejection: Indications of immune rejection of B cell infusions defined by changes in specific blood markers and ex vivo cell assays after either the first or second infusion of donor B cells compared to baseline levels of each.
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Mark Poznansky
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Alira Health
Collaborator
Dana-Farber Cancer Institute
Collaborator
Massachusetts Eye and Ear Infirmary
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
