A phase 1 study of ADI-001: Anti-CD20 CAR-engineered allogeneic gamma delta (γδ) T cells in adults with B-cell malignancies.

• DOI: 10.1200/jco.2022.40.16_suppl.7509
• Publication Date: 2022-06-06T16:57:52Z
• Authors: Sattva Swarup Nee...; Mehdi Hamadani; David Bernard Miklos; Houston Holmes; John Hinkle; Jackie Kennedy-Wilde; Ori Maller; Maggie Weinstein; Francesco Galimi; Rose Lai; Don A. Stevens
• Keywords: Cumulative incidence

7509 Background: ADI-001 is a first-in-class allogeneic gamma delta (γδ) CAR T-cell therapy targeting the B-cell antigen CD20. also has both adaptive and innate cytotoxic effector functions to complement targeting, potentially enhancing efficacy reducing possibility of tumor escape due loss. expresses MHC independent γδ T cell receptors, thus lowering risk graft versus host disease (GvHD) without need for gene-editing. Methods: This phase 1 trial evaluates in adults with relapsed/refractory advanced lymphoma. Eligibility criteria included presence measurable lesions, expression CD20 ≥ 2 prior systemic therapies. All patients received conditioning fludarabine cyclophosphamide. administered at 3 flat dose levels (DL; DL1:3E7, DL2:1E8, or DL3:3E8 cells) + dose-escalation scheme. Dose-limiting toxicities (DLT) were monitored during initial 28-days post-treatment. Patients who completed 28-day DLT period considered evaluable. Treatment-emergent adverse events graded by CTCAE v5.0, immune toxicity assessment grading performed per ASTCT criteria. Objective response rates (ORR) evaluated radiographic review Lugano 2014 Results: As 14 February 2022, eight enrolled six Of these patients, 2/6 female (33%) median age was 62 years (range 45-75). The number therapies 3.5 2-5) IPI score 2-4). One patient anti-CD19 cells lisocabtagene maraleucel. There five large lymphoma one mantle Among evaluable three treated on DL1 DL2. Most related AEs (78%) grade 1/2. AESI: two CRS (one 2) ICANS, only SAEs ICANS. no reported GvHD protocol defined events. At day 28, ORR based upon PET/CT 67% (4/6 patients) CR rate patients). Both months post-treatment follow-up remained CR. Additional data will be presented meeting. Conclusions: well tolerated, favorable safety profile encouraging preliminary efficacy. achieved 28 appeared free further month-3. Clinical information: NCT04735471.