AlloNK (AB-101)

P1, N=18, Recruiting, Artiva Biotherapeutics, Inc.

AB-101 has demonstrated potent killing of tumor cell lines in vitro and in vivo, and preliminary results of a Phase 1/2 trial of AB-101 alone and in combination with rituximab in patients with R/R B cell non-Hodgkin lymphoma demonstrated AB-101 is well tolerated (Khanal et al...Patients aged ≥18 years are planned for enrolment and patients with R/R HL must have received at least two prior lines of therapy including prior combination chemotherapy, brentuximab vedotin (BV) and a checkpoint inhibitor...A run-in phase will assess two dose levels of AFM13 and AB-101 in 4 cohorts (Figure). A standard lymphodepletion regimen of fludarabine (30 mg/m2/day) and cyclophosphamide (300 mg/m2/day) will be administered IV from Day −5 to Day −3 at the start of each treatment cycle...In addition, an exploratory cohort (cohort 5) will begin enrolment of patients with CD30+ PTCL. Disease and efficacy assessments will be conducted at screening and on Day 43 (± 3 days) of each cycle.

P2, N=154, Recruiting, Affimed GmbH | Not yet recruiting --> Recruiting

P2, N=154, Not yet recruiting, Affimed GmbH

Prior to receiving the first dose of AB-101, patients will receive 3 consecutive days of lymphodepleting chemotherapy consisting of fludarabine (30 mg/m2/day) and cyclophosphamide (250 or 500 mg/m2/day). The study is currently enrolling at 10 U.S. centers. (ClinicalTrials.gov Identifier: NCT04673617)

Since anti-CD38 mAbs are combined with glucocorticoids in the clinic, we assessed the impact of dexamethasone and methylprednisolone on ADCC by AB-101. AB-101 has high and consistent expression of CD16 and low CD38 expression and is resistant to daratumumab induced fratricide and hence can be combined with daratumumab without additional engineering such as CD38 knockout. Daratumumab is combined in the clinic with glucocorticoids, immunomodulatory drugs (IMiDs) and proteosome inhibitors (PI). While IMiDs and PIs are reported to enhance NK cell function, glucocorticoids have been shown to diminish NK cell cytotoxicity.