Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 1INTERVENTIONAL

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)

A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Patients With Severe, Treatment-refractory Systemic Lupus Erythematosus

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN). This study includes a dose-escalation stage followed by an expansion stage. It will also evaluate the cellular kinetics (CK), pharmacodynamics (PD), and efficacy of P-CD19CD20-ALLO1.

Who May Be Eligible (Plain English)

Key Who May Qualify: 18-75 years old SLE diagnosis per 2019 EULAR/ACR classification criteria ≥ 24 weeks Autoantibody positive and low complement at screening Treatment refractory: Failed ≥ 2 treatments for at least 3 months Highly active disease: SLEDAI-2K ≥ 8 (excluding alopecia, headache, and fever; additional protocol-specified requirements to enhance specificity of findings) BILAG-2004 cat A in ≥ 1 organ system and/or cat B in ≥ 2 organ systems (excluding constitutional, musculoskeletal, and/or mucocutaneous organ systems for category B) PGA score ≥ 1.0 on a 0 to 3 VAS For patients with lupus nephritis: Biopsy-proven Class III or IV (± Class V) active LN per 2018 ISN/RPS criteria within 12 months of screening Modified NIH activity index ≥ 1/24 UPCR ≥ 1g/g Key Who Should NOT Join This Trial: Participants who are pregnant, breastfeeding, or intend to become pregnant within the timeframe in which contraception is required Prior treatment with CAR T-cell therapy, B-cell-targeting T-cell-dependent bispecific antibody, gene therapy product, total body irradiation, allograft organ transplant, or hematopoietic stem cell transplant Significant organ impairment (renal, hepatic, cardiac, or pulmonary) or uncontrolled medical disease which, in the investigator's opinion would preclude patient participation or that may require treatment with systemic corticosteroids or immunosuppressants during the study Active severe or unstable neuropsychiatric disease Protocol-specified active or chronic infections, recent major episode of infection High-risk medical conditions (e.g. high bleeding risk, history of cancer, recent major surgery, history of HLH/MAS, substance abuse within the previous year) Other protocol-defined inclusion/exclusion criteria apply Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion criteria: 18-75 years old SLE diagnosis per 2019 EULAR/ACR classification criteria ≥ 24 weeks Autoantibody positive and low complement at screening Treatment refractory: Failed ≥ 2 treatments for at least 3 months Highly active disease: SLEDAI-2K ≥ 8 (excluding alopecia, headache, and fever; additional protocol-specified requirements to enhance specificity of findings) BILAG-2004 cat A in ≥ 1 organ system and/or cat B in ≥ 2 organ systems (excluding constitutional, musculoskeletal, and/or mucocutaneous organ systems for category B) PGA score ≥ 1.0 on a 0 to 3 VAS For patients with lupus nephritis: Biopsy-proven Class III or IV (± Class V) active LN per 2018 ISN/RPS criteria within 12 months of screening Modified NIH activity index ≥ 1/24 UPCR ≥ 1g/g Key Exclusion criteria: Participants who are pregnant, breastfeeding, or intend to become pregnant within the timeframe in which contraception is required Prior treatment with CAR T-cell therapy, B-cell-targeting T-cell-dependent bispecific antibody, gene therapy product, total body irradiation, allograft organ transplant, or hematopoietic stem cell transplant Significant organ impairment (renal, hepatic, cardiac, or pulmonary) or uncontrolled medical disease which, in the investigator's opinion would preclude patient participation or that may require treatment with systemic corticosteroids or immunosuppressants during the study Active severe or unstable neuropsychiatric disease Protocol-specified active or chronic infections, recent major episode of infection High-risk medical conditions (e.g. high bleeding risk, history of cancer, recent major surgery, history of HLH/MAS, substance abuse within the previous year) Other protocol-defined inclusion/exclusion criteria apply

Treatments Being Tested

BIOLOGICAL

P-CD19CD20-ALLO1 Cells

P-CD19CD20-ALLO1 cells will be administered intravenously as per the schedule specified in the protocol.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered intravenously.

DRUG

Fludarabine

Fludarabine will be administered intravenously.

DRUG

Rimiducid

Rimiducid will be used as a rescue therapy in the event of the occurrence of severe or life-threatening adverse events. It will be administered intravenously.

Locations (1)

University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, United States