Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis

Summary

This trial aims to find out if obe-cel gets rid of harmful B cells that contribute to systemic lupus erythematosus (SLE)/lupus nephritis (LN) when available treatments have not worked (refractory). The trial includes only 1 group of patients (single arm), including adolescent and adult patients aged 12 to 65 years. The objective is to look for benefits of obe-cel in making signs of LN completely disappear (remission) at 6 months after obe-cel treatment in patients with severe, active LN. The trial will also look for other benefits of obe-cel for up to 24 months after treatment, including the percentage of patients who respond to obe-cel treatment, SLE/LN activity, time to and length of remission, and quality of life. The trial will also assess how long obe-cel stays in the body and the safety of obe-cel.

Eligibility

Inclusion Criteria:

* Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative
* Ability and willingness to adhere to protocol's Schedule of Activities and other requirements
* Participants must be 12 to 65 years of age inclusive at the time of signing the informed consent.
* Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding
* Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus.
* Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith.
* Severe, Active SLE defined as:

  * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 8 points AND
  * Severe active LN based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V (V only in combination with class III or IV)
* Refractory SLE defined as failure to early lines of therapy and to Calcineurin inhibitors AND B cell-targeting agents

Exclusion Criteria:

* Any medications prohibited by the protocol.
* Prior treatment at any time with anti-CD19 therapy.
* More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible.
* Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant.
* History of primary antiphospholipid antibody syndrome.
* Active or uncontrolled fungal, bacterial, or viral infection
* History of malignant neoplasms unless disease free for at least 24 months.
* History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant.

Conditions2

Interventions1

Locations11 sites

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