Trials Today

Eligibility

Eligible Ages

Between 18 Years and 70 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

INCLUSION:

1. Males or females aged 18 through 70 years inclusive at the time of consent.

2. Written informed consent in accordance with federal, local, and institutional
guidelines.

3. Must be able and willing to adhere to the study visit schedule and other protocol
requirements

4. Adequate hepatic, renal, pulmonary, and cardiac function

5. Have a clinical diagnosis of SLE according to the EULAR/ American College of
Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10.

6. Have used at least two standard immunosuppressants (including one biological agent).

7. SLEDAI-2K score ≥6 at screening.

8. Must include a significant SLE related organ involvement: arthritis, myositis, rash,
alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.

9. For lupus nephritis: Diagnosis of proliferative lupus nephritis 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 LN according to the WHO 2003 ISN/RPS
classification.

EXCLUSION:

1. Have received prior treatment with CAR T therapy directed at any target.

2. Have received any therapy that is targeted to CD19 and/or BCMA

3. Received allogenic stem cell transplant or autologous stem cell transplant.

4. An active malignancy that is progressing or requires active treatment.

5. Primary immunodeficiency

6. Active viral or bacterial infection