Mark Poznansky
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.
This is a phase 1, non-randomized, open-label study to assess the safety and pharmacokinetics of up to 2 doses of donor B cells. Up to 10 recipients will each receive 2 infusions of donor B cells at doses of ≥ 2.0 x 10\^8 and ≤ 1.0 x 10\^9 donor B cells delivered at least 60 days apart. The first three participants will receive infusions as inpatients in a staggered fashion 30 days apart. After completion of a 30-day observation of the third participant after the second infusion, study investigators will determine whether the infusions are safe and well-tolerated and that there are no indicati…
Inclusion Criteria: 1. Confirmed diagnosis of ALS that meets the revised El Escorial criteria for probable lab-supported, probable, or definite ALS. 2. Age 18-70 years. 3. Vital capacity of \>65%. 4. ALSFRS-R score of \>30. 5. Absence of clinically important abnormalities on screening labs, including but not limited to ALT/AST \< 3x ULN, Bilirubin \<1.5x ULN (unless there is documented history of Gilbert's disease), serum Cr \< 1.5x ULN, WBC \> 3.5, HCT \>33, Plts \> 120. 6. Negative tests for HIV, HepB sAg, HCV. 7. Available potential donor who must be a haploidentical match to the recipient…
infusion of haploidentical donor CD19+ B cells
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