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CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

StatusRecruiting
PhasePhase 1/2
Started2025-04-18
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 30, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 30 days later Jul 1, 2026 → Jul 31, 2026
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from Beijing GoBroad Hospital

Amendment history

2026-07-29
Study Status, Study Description, Conditions, Outcome Measures v4
Primary endpoint(s) modified2 entries, revised
WasAdverse events (AEs), Dose-limiting toxicity (DLT)
NowPhase I (Dose-Escalation/Dose-De-escalation Phase), Phase II (Dose-Expansion Phase)
Primary completion pushed: 2026-07-01 → 2026-07-31
Secondary endpoints2 entries, revised
OverallPhase remission rateI (ORRDose-Escalation/Dose-De-escalation Phase) SeriousPhase adverseII event（SAE(Dose-Expansion Phase)
2026-02-27
Study Status, Study Description, Eligibility, Contacts/Locations v3
Eligibility criteria+1,338 characters
Inclusion Criteria: 1. Refractory lupus nephritis (LN): Definition: A treatment regimen using at least one immunosuppressive agent (including glucocorticoids, CTX, tacrolimus, mycophenolate mofetil, and cyclosporine) that does not induce remission after 3 to 6 months, while proteinuria or persistent [...] Inclusion Criteria 1. Refractory Lupus Nephritis（LN）: Patients who meet all the following requirements can be enrolled in the group. Definition: Failure to achieve induction remission after 3 to 6 months of treatment with at least one immunosuppressive agent (including glucocorticoids, cyclophospham [...] [...]
Study sitesdetails revised at 1 of 1 site
2025-05-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2025-04-25
Study Identification, Study Status, Conditions, Arms and Interventions v1
InterventionsDrug: CD19-BCMA CAR-T cells infusion (Drug)→CD19-BCMA CAR-T cells infusion (Drug)
Study title-66 characters
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH: a Single-center, Open, Non-randomized, Single-arm Clinical Study
2025-04-21
Original filing
Beijing GoBroad Hospital
35 trials monitored
See 2 trials at risk
Hypertension
1,786 trials monitored
See 77 trials at risk
Lupus (SLE)
648 trials monitored
See 25 trials at risk
Scleroderma
302 trials monitored
See 9 trials at risk
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) and other autoimmune diseases (AID) receive CD19-BCMA CAR T cell therapy. Phase I (Dose-Escalation/Dose-De-escalation Phase)：The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, pSS-PAH and other autoimmune diseases (AID).Phase I (Dose-Escalation/Dose-De-escalation Phase)：Primary Endpoint: Safety, tolerability, and determination of the optimal biological dose (OBD) and the Phase II recommended dose (RP2D) in patients with SLE-LN, SSc, pSS-PAH, and other autoimmune diseases (AID).Phase II (Dose-Expansion Phase):Overall remission rate (ORR) \[Time Frame: 90,180 Days\]
Trial Details
NCT Number NCT06947460
Lead Sponsor Beijing GoBroad Hospital
Conditions Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension, Other Autoimmune Diseases (AID)
Enrollment 45 participants
Start Date 2025-04-18
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30