Clinical trials: Refractory Systemic Lupus Erythematosus
Systemic Lupus Erythematosus, Active Refractory Rheumatoid Arthritis
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and…
- Trial name
- NCT06570798
- Testing
- Inebilizumab, Blinatumomab
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 220 people
- Sponsor
- Amgen
Refractory Systemic Lupus Erythematosus
NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.
- Trial name
- NCT07083349
- Testing
- NK510 : allogeneic genetic modified NK
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Refractory Systemic Lupus Erythematosus
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06530849
- Testing
- GC012F Injection
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- Gracell Biotechnologies (Shanghai) Co., Ltd.
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA.
- Trial name
- SELECT-SLE (NCT07523542)
- Testing
- Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg)., Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Beijing Biotech
Systemic Lupus Erythematosus (SLE), Refractory
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the…
- Trial name
- NCT06892145
- Testing
- MC-1-50
- Where
- 2 sites in China
- Volunteers
- 12 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV
AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus
AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells.
- Conditions
- Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus, SLE
- Trial name
- NCT06265220
- Testing
- AB-101, Cyclophosphamide, Fludarabine
- Where
- 9 sites in United States
- Volunteers
- 51 people
- Sponsor
- Artiva Biotherapeutics, Inc.
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
Refractory Active Systemic Lupus Erythematosus
A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus
This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and…
- Trial name
- NCT06694298
- Testing
- SYS6020
- Volunteers
- 50 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Relapsed/Refractory, Systemic Lupus Erythematosus (SLE)
BCMA-CD19 cCAR T Cell Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with relapsed and/or refractory SLE.
- Trial name
- NCT05474885
- Testing
- BCMA-CD19 cCAR T cells
- Where
- China
- Volunteers
- 15 people
- Sponsor
- iCell Gene Therapeutics