First Allogeneic RNA Cell Therapy Clinical Trial Begins in Multiple Myeloma

A phase 1/2a clinical trial of the first allogeneic RNA cell therapy in multiple myeloma has begun after dosing its first patient this week. The trial aims to examine the treatment — Descartes-25 — in 20 patients with relapsed/refractory multiple myeloma.

“Patients with relapsed and/or refractory multiple myeloma have few treatment options remaining,” said Dr. Kenneth Anderson, Kraft Family Professor of Medicine at Harvard Medical School and director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics at Dana-Farber Cancer Institute in Boston, in a news release from Cartesian Therapeutics.

Descartes-25 is an RNA cell therapy that affects the antibody and cell activity in a patient’s body to deliver antitumor treatment to the tumor microenvironment. The drug is allogeneic, meaning that it is created from blood or tissue unrelated to the patient.

In this dose-escalation study, researchers hope to examine the safety, tolerability and efficacy of the treatment. The primary goal of the trial is to determine the maximum tolerated dose (during a one-year time frame). Secondary goals include overall response rate (which shows the percentage of patients whose disease responds to treatment) and median duration of response (length of time a tumor continues responding to treatment without growing or spreading), also measured during a one-year time frame.

Patients are eligible if they are aged over 18 years and have relapsed/refractory multiple myeloma that progressed after two lines of treatment. They may be excluded if they have active plasma cell leukemia.

“A cell therapy that locally delivers a combination of a BCMA-bispecific antibody and IL-12, without using lymphodepleting chemotherapy, is an elegant and highly innovative approach,” Anderson said. “If approved, it will be a welcome addition to our toolkit for treating this currently incurable disease.”

According to Cartesian Therapeutics, the company developing the treatment, Descartes-25 would be the first off-the-shelf (meaning the cells involved in the drug do not have to be collected from the patient) RNA cell therapy to enter clinical trials for cancer. It has also been given U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) allowance, which means it has been authorized to be administered to humans.

The trial is currently recruiting patients and is planned to occur at the Center for Cancer and Blood Disorders in Bethesda, Maryland as well as the Medical College of Wisconsin in Madison.

“With Descartes-25, Cartesian scientists used RNA Armory® technology to convert stem cells into a targeted combination therapy,” said Dr. Michael Singer, chief scientific officer of Cartesian Therapeutics. “Therefore Descartes-25 is not just a potent antitumor therapy.It’s also a blueprint for future RNA cell therapies to deliver three or more rationally selected and spatially targeted combination therapeutics for a diverse array of diseases.”

The trial has a completion date goal of January 2023.

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