FDA Grants Fast Track Designation to CAR T-Cell Therapy for Non-Hodgkin Lymphoma


Investigational CAR T-cell therapy is currently being evaluated in an ongoing dose escalation phase 1 trial to analyze its safety and tolerability in treating non-Hodgkin lymphoma.

The FDA has awarded fast track designation to ADI-001 (Adicet Bio, Inc), an investigational chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma (NHL).1

The investigational therapy, which targets CD20, is currently being evaluated in an ongoing dose escalation phase 1 trial to analyze its safety and tolerability in treating NHL. The FDA designation was based on the treatment’s potential to address an unmet need in adult patients with NHL.

“Fast track designation represents an important milestone in the clinical development of ADI-001,” said Chen Schor, president and chief executive officer of Adicet Bio, in a press release. “We believe ADI-001 is unique in that it is designed to target malignant B cells by leveraging the innate and adaptive receptors found naturally on gamma delta T cells with the added benefit of an engineered anti CD20 CAR. We remain optimistic about the potential of our program and look forward to reporting additional data from the phase 1 trial of ADI-001 in the first half of 2022.”

ADI-001 is an allogeneic gamma delta CAR T-cell therapy targeting malignant B cells through a CD20-directed CAR and the innate gamma delta and T-cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with a CD20-directed CAR have demonstrated significant antitumor activity in preclinical models, showing long-term disease stabilization. The treatment is currently being evaluated in the first-in-human phase 1 GLEAN-1 trial (NCT04735471) in NHL, which announced positive interim data in December 2021.2

At the data cutoff date of November 22, 2021, 6 patients were administered ADI-001 in the GLEAN-1 trial. The first 2 patients who were enrolled at the lowest dose level did not reach the day 28 assessment and were not evaluable for efficacy per protocol.

Further, 3 of 4 evaluable patients achieved responses, which included 2 complete responses (CR) and 1 partial response that was characterized as a near CR. Patients were heavily pre-treated, with a median of 5 lines of prior systemic therapy, including 1 patient previously administered autologous CD19 CAR T, who achieved CR following a single infusion of ADI-001 administered at the lowest dose level.

Among the 3 responder patients, 1 had diffuse large B-cell lymphoma and had received 5 previous lines of therapy, which included 2 cycles of CD19-directed CAR T-cell therapy; 1 patient had follicular lymphoma that transformed into a large B-cell tumor and had received 4 prior lines of therapy; and the third had mantle cell lymphoma and had received 5 prior lines of therapy.

“We are extremely excited to see such profound early complete responses in our phase 1 dose-finding study evaluating ADI-001 as monotherapy among patients with very advanced cancer starting at our first dose level of 30 million CAR+ cells," Schor said in a press release. "Data to-date suggest that ADI-001 is highly clinically active. We look forward to reporting additional data in the first half of 2022 and to rapidly progressing our pipeline to realize the full potential of our gamma delta CAR T cell platform for patients.”


  1. Adicet Bio receives FDA fast track designation for lead candidate ADI-001. News release. Adicet Bio, Inc. April 19, 2022. Accessed April 20, 2022. https://bwnews.pr/3vwser0
  2. Adicet Bio announces positive interim clinical data from first-ever allogeneic, off-the-shelf, gamma delta CAR T investigational cell therapy. News release. December 6, 2021. Accessed April 20, 2022. https://bit.ly/38TCfGX
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