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Promising autoimmune therapy trial pulled before it even started

NCT ID NCT06913608

Disease control Sponsor: Calibr, a division of Scripps Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to test a new treatment for people with autoimmune diseases like lupus, scleroderma, and myositis. It combined a specially engineered immune cell product (CLBR001) with a targeted antibody drug (SWI019), with or without a preparatory chemotherapy step. However, the trial was withdrawn before enrolling any participants, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

Mar 2026

An estimate. Start dates often move.

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women or men age ≥18 of age at time of consent. * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of this study. * Adequate hematological, liver, pulmonary, and cardiac function * Willing to participate to participate in long term follow up study. * Confirmed diagnosis of moderate to severe systemic lupus erythematosus with lupus nephritis, systemic lupus erythematosus with extrarenal lupus, systemic sclerosis, and idiopathic inflammatory myositis. * Failed at least two immunosuppressive treatments Exclusion Criteria: * Inability to tolerate washout of prior therapy. * Not willing/understanding the requirements of the clinical study * Dependent on hemodialysis for a period of greater or equal to 3 months. * Known hypersensitivity to prednisone or to both tocilizumab siltuximab. * Have received plasmapheresis within 14 days prior to informed consent. * Active bacterial, viral and/or fungal infection. * Prior autologous/allogeneic stem cell transplant or solid organ transplant. * Prior lentiviral or retroviral based therapy including CAR-T cell therapy. * History or concurrent malignancy with active treatment in the past 5 years * HIV-1 and HIV-2 antibody positive subjects. * History of central nervous system diseases (such as seizure, psychosis, organic brain syndrome or cerebrovascular accident).

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy idiopathic inflammatory myopathy myositis disease systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic inflammatory myopathy (IIM) Systemic lupus erythematosus (SLE) Systemic sclerosis (SSC)

More trials for these conditions

Other studies related to the condition(s) this trial covers.