Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Recruiting
Phase 2Interventional Study
Lupus Nephritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
35 (estimated)
Sponsor
Autolus Limited · Industry
Who this trial is looking for
This trial is looking for people aged 12 to 65 with severe lupus that is hard to treat and causing kidney problems. Participation involves receiving a single treatment of a drug called obe-cel after a procedure to prepare the body.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 12 and 65 years old.
I have been diagnosed with systemic lupus erythematosus (SLE).
I have active lupus nephritis.
I have high levels of specific autoantibodies in my blood.
I am willing to follow the study protocol.
I can give my written consent to participate or have a guardian do it.
I have severe, active SLE as defined by specific scoring.
You may not be able to join if
I have received anti-CD19 therapy before.
I have had more than one severe lupus flare during screening.
I have significant organ damage from SLE that won't improve.
I have a history of antiphospholipid antibody syndrome.
I have an active infection that is not under control.
I have had cancer in the last 2 years.
I have had a transplant of any organ or stem cells.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 t…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.