Allogene Therapeutics is looking to expedite the enrolment of its ‘potentially’ pivotal Phase II trials for its chimeric antigen receptor (CAR)-T cell therapies, ALLO-501/501A, following updated results from its Phase I trials (ALPHA – NCT03939026 and ALPHA2 – NCT04416984).

The clinical and dosing data from the Phase I ALPHA/ALPHA2 trials in 33 CAR-T cell naïve patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) was presented at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. Initial trial data was presented at the American Society of Clinical Oncology (ASCO) annual meeting.

Pfizer, a major financial contributor to Allogene’s CAR-T cell therapies with a 25% ownership of Allogene, filed 482 patents for CAR-T cell therapies between 2010 and 2021, according to GlobalData, the parent company of Clinical Trials Arena.

Phase I ALPHA and ALPHA2 trial data

The Phase I open-label ALPHA and ALPHA2 trials evaluated the safety, efficacy, and pharmacodynamics of ALLO-501, an anti-CD19 allogeneic CAR-T cell therapy, and ALLO-647, an anti-CD52 monoclonal antibody, in patients with r/r LBCL.

The ALPHA and ALPHA2 Phase 1 trials assessed the safety, tolerability, and preliminary efficacy of increasing dose levels of ALLO-501 and ALLO-501A, allogeneic CAR-T product candidates that target CD19. In addition to exploring varying dose levels, these studies have evaluated various doses of ALLO-647, Allogene’s proprietary lymphodepleting antibody designed to prevent premature rejection of allogeneic CAR-T cells.

Patients received a lymphodepletion regimen (FCA90) of escalating doses of ALLO-647 in combination with chemotherapeutics, fludarabine, and cyclophosphamide, followed by a single or double infusion of ALLO-501/501A.

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By GlobalData

Data collected before the 20 April cut-off date from 33 patients was examined. Of these, 12 patients received a single dose of ALLO-501/501A and FCA90 lymphodepletion (Phase II regimen), whereas six patients received a single dose of ALLO-501/501A and FCA<90 lymphodepletion. Fifteen patients received treatment with double infusion of ALLO-501/501A and split lymphodepletion.

For all 33 patients, the complete response (CR) rate was 42%. Of the 12 patients on the Phase II regimen, seven achieved CR. The median duration of response for all 33 patients, including those on the phase II regimen, was 23.1 months.

Allogene chief medical officer Zachary Roberts said: “Based on these data, we were able to select an optimal dosing regimen of CAR-T treatment that we believe will potentially benefit patients without the lengthy wait time and risk of manufacture failure associated with autologous CAR-T.”