Clinical trials: CD19/BCMA CAR T-cells
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single…
- Trial name
- NCT07328581
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Inflammatory Myopathy
BCMA-CD19 cCAR-T for the Treatment of Refractory Inflammatory Myopathy
This single-arm, open-label, phase I trial evaluates the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15/IL15sushi cCAR T cells) in patients with refractory Idiopathic inflammatory myopathy (IIM).
- Trial name
- NCT07715136
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR-T
- Where
- China
- Volunteers
- 10 people
- Sponsor
- iCell Gene Therapeutics
Lupus Nephritis
Universal CAR-T Cell Therapy for Refractory Lupus Nephritis
This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis.
- Trial name
- NCT06681337
- Testing
- BCMA CART + CD19 CART
- Volunteers
- 10 people
- Sponsor
- Bioray Laboratories
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Inflammatory Bowel Diseases (IBD)
BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)
This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15/IL15sushi cCAR T cells) in patients with relapsed and/or refractory…
- Trial name
- NCT07544160
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T
- Where
- China
- Volunteers
- 18 people
- Sponsor
- iCell Gene Therapeutics
Relapsed/Refractory Multiple Myeloma
AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.
- Trial name
- DURGA-1 (NCT05850234)
- Testing
- AZD0120
- Where
- 36 sites in United States
- Volunteers
- 232 people
- Sponsor
- AstraZeneca
SLE - Systemic Lupus Erythematosus
CD19/BCMA CAR-T for SLE
The purpose of this clinical trial is to learn if CD19/BCMA CAR-T works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the CD19/BCMA CAR-T cell product.
- Trial name
- NCT07266337
- Testing
- CD19/BCMA CAR T-cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Chengdu Ucello Biotechnology Co., Ltd.
Primary Light Chain (AL) Amyloidosis
A Phase I/II Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed/Refractory Primary AL Amyloidosis
This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed/refractory primary light chain (AL) amyloidosis.The primary objectives are to assess the safety of FKC289 and to establish the…
- Trial name
- NCT07765524
- Testing
- FKC289 infusion
- Where
- 11 sites in China
- Volunteers
- 32 people
- Sponsor
- Shenzhen Fosun Kairos Biotechnology Co., Ltd.
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
Acute Lymphoblastic Leukemia, Lymphoma
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.
- Conditions
- Acute Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma
- Trial name
- NCT05618041
- Testing
- CAR-T Autologous T cell injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
Relapsed Refractory Multiple Myeloma
A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd [daratumumab, carfilzomib, and dexamethasone], DPd [daratumumab…
- Trial name
- DURGA-4 (NCT07391657)
- Testing
- AZD0120, Daratumumab, Carfilzomib
- Where
- 143 sites in United States, Australia and 13 more
- Volunteers
- 508 people
- Sponsor
- AstraZeneca