Phase 1/2 trial of relma-cel, a CAR T-cell therapy, to open in China

Study to test candidate in people with moderate-to-severe, refractory SLE

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by Lindsey Shapiro |

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JW Therapeutics has received approval from Chinese authorities to open a clinical trial of its CAR T-cell therapy, relmacabtagene autoleucel (relma-cel), in systemic lupus erythematosus (SLE) patients with moderate-to-severe and treatment-resistant active disease.

Although not approved for SLE or other autoimmune disorders, relma-cel is available under the brand name Carteyva to treat certain blood cancers in China, and it is under investigation in several others.

Clearance given by the National Medical Products Administration of China to the trial application allows the company to expand clinical testing to SLE patients.

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The Phase 1/2 trial (NCT05765006) is currently recruiting up to 24 SLE patients, ages 18 to 70, at a single site in Shanghai, where the company is based. Eligible participants will have had SLE for at least six months, and active disease for at least two months after the use of standard SLE treatments.

“Autoimmune diseases are a critical part of JW Therapeutics’ strategy,” James Li, JW’s co-founder, chairman, and CEO, said in a company press release. “We are committed to maximizing the clinical value of relma-cel, and look forward to providing a new treatment option for patients with autoimmune diseases.”

SLE is caused by the production of self-reactive antibodies, known as autoantibodies, that target a person’s tissues. As with other types of antibodies, autoantibodies are produced by immune B-cells.

Chimeric antigen receptor (CAR) T-cell therapies aimed at depleting these autoantibody-producing cells are emerging as a promising approach in treating SLE, the most common form of lupus.

With these therapies, a person’s immune T-cells are isolated from the bloodstream and engineered in the lab to express a receptor protein, or CAR, that’s designed to recognize a protein specifically associated with B-cells.

The modified T-cells are then infused back to the patient after a course of chemotherapy. At that point, they are equipped to recognize and attack disease-causing B-cells. By killing B-cells that produce autoantibodies, CAR T-cell therapies may be able to prevent disease relapses and slow or halt the organ damage seen in SLE patients.

Relma-cel targets a protein called CD19, which is specifically but widely found on B-cells and their antibody-producing descendants. It is designed similarly to Breyanzi (lisocabtagene maraleucel), a CAR T-cell therapy marketed by Juno Therapeutics, part of Bristol-Myers Squibb, for certain B-cell associated cancers.

The therapy was found to be safe in clinical trials that led its approval in China for certain cancers.

The open-label SLE trial will be conducted in two parts. Its first part will assess the safety and tolerability of various doses of relma-cel in order to determine the optimal dose to be used in the Phase 2, or second part, of the study.

In its Phase 2, the trial will evaluate that dose’s safety and efficacy, in addition to relma-cel’s pharmacokinetics — its movement into, through, and out of the body — and pharmacodynamics, or effects on the body, the company reported.