P-CD19CD20-ALLO1 Cells
BiologicalP-CD19CD20-ALLO1 cells will be administered intravenously as per the schedule specified in the protocol.
NCT Number: NCT06984341
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1
University of Alabama at Birmingham: The Kirklin Clinic, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
P-CD19CD20-ALLO1 cells will be administered intravenously as per the schedule specified in the protocol.
Cyclophosphamide will be administered intravenously.
Fludarabine will be administered intravenously.
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.
Time frame: Day 1 up to Day 29
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: From Week 24 through Week 52
Drug-free DORIS is defined as a SLEDAI-2K = 0 and a PGA <0.5 (on a 3-point PGA-visual analog scale [VAS]), without corticosteroids or other immunosuppressants.
Time frame: Up to 5 years
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: GA45767 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S.)
Genentech, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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