RightFit
RecruitingPhase 2

Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)

A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Obe-cel Administration: If the participant's eligibility for receiving obe-cel infusion is confirmed, the participant is to receive a single obe-cel infusion on Day 1. 3."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well obe-cel works and how safe it is for people ages 12 to 65 with severe lupus that has not responded to past treatments and active kidney inflammation from lupus. Obe-cel is given once, after treatment to lower the number of certain immune cells.

The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You or your legal guardian or representative must sign a form agreeing to join the study.
  • You must be willing and able to follow the study schedule and rules.
  • You must be 12 to 65 years old when the consent form is signed.
  • Female participants must not be pregnant or breastfeeding.
  • You must have systemic lupus erythematosus (SLE), called lupus, that meets the study’s diagnosis rules.
  • A blood test must show at least one of these antibodies, which can attack your own body: ANA, anti-dsDNA, or anti-Smith.
  • Your lupus activity score must be at least 8 on the SLEDAI-2K scale. A kidney tissue test must show severe, active lupus kidney disease: class III or IV, with or without class V.
  • Your lupus must not have responded to past treatments.

Who can't join

  • You have ever had anti-CD19 treatment, which targets certain immune cells.
  • During screening, you have more than one sudden, severe lupus flare that needs treatment right away or prevents a required break from immune-suppressing medicines.
  • You have serious lupus-related organ damage that is likely permanent, such as kidney failure, and the study doctor thinks this treatment is unlikely to help.
  • You have a history of primary antiphospholipid antibody syndrome, a condition that can cause blood clots.
  • You have an active or uncontrolled infection caused by a fungus, bacteria, or virus.
  • You have a history of cancer and have not been cancer-free for at least 24 months.
  • You have had a heart, lung, kidney, liver, or blood-forming stem cell transplant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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: * SLEDAI-2K score of ≥ 8 points AND * Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV) * Refractory SLE defined as failure to previous lines of therapy Exclusion Criteria: * 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

Study sites (3)

NY

TX