An off-the-shelf cellular therapy that combines Epstein Barr Virus–Specific T cells and a CD30-targeting chimeric antigen receptor product demonstrated safety and early efficacy in a group of patients with CD30-positive lymphomas.
Patients with relapsed or refractory CD30-positive lymphoma have demonstrated encouraging clinical activity following receipt of the allogeneic TT11X therapy, an off-the-shelf cellular therapy, according to results of a phase 1 trial (NCT04288726) presented at the 24th Annual Meeting of American Society of Gene and Cell Therapy (ASGCT 2021).
The ongoing trial is examining the CD30-targeting chimeric antigen receptor (CAR) T-cell therapy, which uses augmented Epstein Barr Virus–Specific T cells (EBVSTs) coupled with CD30-CAR technology to prevent graft rejection.
“This is early but significant data supporting development of Tessa’s ‘off-the-shelf,’ allogeneic cell therapy,” Jeffrey H. Buchalter, president and CEO of the company responsible for developing the treatment, Tessa Therapeutics, said in a press release. “We believe there is an enormous potential for our allogeneic CD30-CAR EBVST platform, and we remain committed to our longer-term plan to develop this platform to tackle both hematologic malignancies and solid tumors where there is significant patient need.”
The primary end point of the ongoing trial was the rate of dose-limiting toxicity with secondary measures of antitumor objective response rate, duration of response, rate and duration of stable disease, and progression-free survival.
At ASGCT, data from 6 treated patients were presented and showed a favorable safety profile and positive clinical activity at the lowest and second dose levels of 4 × 107 CD30.CAR EBVSTs and 1 × 108 CD30.CAR EBVSTs, respectively.
Of note, there were no serious adverse events or dose-limiting toxicities and no events of graft-versus-host disease, cytokine release syndrome, or neurotoxicity. Three out of 5 patients evaluated for response experienced disease control and there was 1 partial response.
The target enrollment for the study is 18 participants between the ages of 12 and 75 years. Inclusion criteria include patients with a diagnosis of Hodgkin lymphoma, aggressive non-Hodgkin lymphoma, ALK-negative anaplastic T-cell lymphoma or another peripheral T-cell lymphoma, or ALK-positive anaplastic T-cell lymphoma. CD30 positivity must be confirmed using a CLIA-certified pathologic assay. Patients must have recovered from all acute nonhematologic toxic effects from prior treatment lines and levels of bilirubin and aspartate aminotransferase must be within a certain criterion determined by the upper limits of normal.
Patients receiving other investigational agents or any tumor vaccines within the previous 6 weeks and those having CD30 antibody–based therapy within 4 weeks are excluded from participation. History of hypersensitivity reactions to murine protein-containing products; pregnancy or lactation; tumors that could cause airway obstruction; use of corticosteroids equivalent to prednisone at 10 mg/day; active, significant, and uncontrolled infections; and symptomatic cardiac disease are all excluding factors.
The trial will continue to enroll to 3 escalating dose levels, with the highest being 4 × 108 CD30.CAR EBVSTs. Full results from the trial are expected to be presented by the end of 2021.
“We are encouraged by the early data generated on the study. The therapy has been well tolerated with no evidence of GVHD or any severe adverse events, with encouraging clinical activity,” Carlos Ramos, MD, lead principal investigator and professor at the Center for Cell and Gene Therapy and member of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, said in a press release. “While these are preliminary results, the data gleaned from the first 5 patients suggest that allogeneic CD30-CAR EBVSTs may be able to overcome the safety and tolerability challenges that are common to allogenic cell therapies. We look forward to completing enrollment on the trial and further developing our understanding of this potential new therapy platform for oncology.”
Tessa Therapeutics Announces Positive, Topline Data from Ongoing Phase 1 Trial of Allogeneic, “Off-the-Shelf” Cell Therapy, in Patients with Relapsed or Refractory CD30-Positive Lymphoma. News release. Tessa Therapeutics. May 14, 2021. Accessed May 17, 2021. https://bit.ly/3okITd6