Every patient evaluated in a small early-stage lupus trial has stopped taking immunosuppressant drugs after a single infusion of an experimental donor-derived cell therapy, Adicet Bio reported on Sept. 28. More than half of the patients followed for a full year met a standard definition of remission.
For the roughly 204,000 Americans living with systemic lupus, most of them women, the result points toward a different kind of treatment. It is not a new option patients can request at their next appointment. The therapy, prulacabtagene leucel, or prula-cel, has been tested in a few dozen people, is not approved, and has not yet entered the larger pivotal study that regulators require.
Early Results From 22 Heavily Treated Patients
As of an Aug. 28 data cutoff, 22 patients could be evaluated for effectiveness, including 16 with lupus nephritis, the kidney inflammation that can progress to kidney failure. Every patient had already tried at least three therapies, and 71% had tried four or more. Follow-up ranged from six to 21 months, and 13 patients had reached one year.
At 12 months, 54% of evaluable patients met DORIS remission criteria, and half of the evaluable lupus nephritis patients had a complete kidney response. All patients stopped immunosuppressants, and all but one lowered steroids to 5 milligrams of prednisone or less per day. Antibody-producing B cells fell to undetectable levels in all 22 patients before returning, a change the company describes as an immune reset.
“Notably, these remissions were achieved off immunosuppression and were accompanied by biological evidence of an immune reset,” said Lloyd Klickstein, M.D., Ph.D., Adicet’s interim chief medical officer.
Safety is the other half of the story. Among 24 patients assessed for safety, 25% had mild or moderate cytokine release syndrome, an inflammatory reaction common with CAR-T therapy, and none had severe cases. The company reported no nerve toxicity and no cases of IEC-HS, a dangerous hyperinflammatory reaction. Infections occurred in 54% of patients, and 8.3% had grade 3 or higher infections.
That matters because MedicalDaily reported earlier this month that Novartis paused eight autoimmune CAR-T trials after three patients died from IEC-HS, while Bristol Myers Squibb paused enrollment in its own program. Those products are built from each patient’s own cells. Prula-cel is made from donor gamma delta T cells and targets a B-cell marker called CD20, Fierce Biotech reported. Chen Schor, Adicet’s president and chief executive, told the outlet that “this might be a new era in autoimmune diseases.”
Women of Color Carry the Heaviest Lupus Burden
The CDC estimates that 9 in 10 people with lupus are women, and risk is highest between ages 15 and 44. Black and American Indian and Alaska Native women are two to three times more likely than White women to develop lupus, according to the CDC, and a CDC-funded study in Georgia’s Fulton and DeKalb counties found that Black patients died more than 10 years younger than White patients.
The Lupus Foundation of America reports that lupus ranks among the leading causes of death in young women, placing among the top 10 causes for Black and Hispanic women ages 15 to 44. A recent CDC-authored analysis of lupus deaths found the highest death rates in the South.
For these families, current care often means years of layered medications, frequent lab monitoring, and difficult decisions about work and pregnancy. A treatment that allows patients to come off long-term immunosuppression would change daily life, which is exactly why the early evidence must be read carefully.
Small Numbers, Company Data, and a Long Road to Approval
This was a Phase 1 study without a comparison group. The figures come from a company announcement, not a peer-reviewed paper, and only 13 patients had a full year of follow-up. With numbers this small, one or two patients can shift a percentage sharply. Long-term durability and rare side effects remain unknown.
Adicet said it has aligned with the FDA on a single-arm pivotal study in lupus nephritis patients who have not responded adequately to at least two immunosuppressants, with complete kidney response at 12 months as the main goal. Start-up work is planned for the fourth quarter of 2026, and the company plans to later expand to lupus patients without kidney disease. Because the main result is measured a full year after treatment, the pivotal data and any FDA review that follows remain well in the future.
Patients should not stop or reduce any lupus medication because of this news. Stopping hydroxychloroquine, steroids, or immunosuppressants without medical guidance can trigger flares.
Steps for Patients Weighing a Lupus Trial
Patients interested in prula-cel can review the study’s listing on ClinicalTrials.gov, which includes eligibility details and contacts. Early CAR-T trials generally enroll people whose disease persists despite several standard treatments, so a rheumatologist or nephrologist is the best first call.
Useful questions for a care team include whether the patient’s disease history fits the criteria, how often trial visits require travel, which costs the sponsor covers, and how infections are monitored afterward. The therapy is given as an outpatient infusion, but follow-up still requires repeated visits.
Anyone with lupus should seek urgent care for chest pain, shortness of breath, a severe headache, confusion, or a fever while taking immunosuppressants. New leg swelling or foamy urine can signal kidney involvement and warrants a prompt call to a doctor.
Key Questions Answered
What did the trial find? In 22 evaluable patients, 54% reached remission at 12 months, half of the lupus nephritis patients had a complete kidney response, and every patient stopped immunosuppressants.
Is prula-cel available to patients? No. It is experimental and available only through clinical trials.
How is it different from paused CAR-T programs? It uses donor gamma delta T cells rather than each patient’s own cells, and no IEC-HS cases were reported in this study.
Who is most affected by lupus? Women ages 15 to 44, with higher risk among Black and American Indian and Alaska Native women.
Should patients change their medications? No. Any change should be discussed with a rheumatologist first.
What happens next? Adicet plans a pivotal study start-up in late 2026 and another data update in mid-2027.
Published by Medicaldaily.com
