Clinical trials: CD19/BCMA CAR T-cells
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
Multiple Sclerosis
An Open-label Study of AZD0120 in Adults With Multiple Sclerosis
This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis.
- Trial name
- ZENITH (NCT07224373)
- Testing
- AZD0120 - Regimen 1, AZD0120 - Regimen 2
- Where
- 19 sites in United States, Australia and 3 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
POMES Syndrome, Relapsed and Refractory POMES Syndrome
Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R POMES
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory POMES Syndrome.
- Trial name
- NCT03879382
- Testing
- anti-CD19/BCMA CAR-T cells, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hrain Biotechnology Co., Ltd.
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
Connective Tissue Diseases
Clinical Study on the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases
This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue…
- Trial name
- NCT07152223
- Testing
- CAR-T
- Where
- China
- Sponsor
- Guangzhou Bio-gene Technology Co., 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
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.
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
Multiple Myeloma
A Study of GC012F in Patients With Relapsed/Refractory Multiple Myeloma
This study is a single-arm, open-lable, phase I/II study to evaluate the efficacy and safety of GC012F in subjects with relapsed/refractory multiple myeloma.
- Trial name
- DURGA-3 (NCT06235229)
- Testing
- GC012F
- Where
- 10 sites in China
- Volunteers
- 110 people
- Sponsor
- Gracell Biotechnologies (Shanghai) 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
SLE, LN
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN…
- Conditions
- SLE, LN, ANCA Associated Vasculitis, ANCA-Associated Glomerulonephritis
- Trial name
- NCT07203404
- Testing
- RD06-05 CART Cell Injection
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Relapsed, Refractory
A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory…
- Conditions
- Relapsed, Refractory, Multiple Myeloma
- Trial name
- NCT06732232
- Testing
- CD19/CD20/BCMA CAR-T
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd
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
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
Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies.
- Conditions
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm
- Trial name
- ADAPT-HEM (NCT07523555)
- Testing
- Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module, Autologous BCMA/CD19 dual-target CAR-T module
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Beijing Biotech
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
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.
Relapsed AL Amyloidosis, Refractory AL Amyloidosis
A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.
- Conditions
- Relapsed AL Amyloidosis, Refractory AL Amyloidosis, Light Chain Amyloidosis, Amyloidosis
- Trial name
- ALACRITY (NCT07081646)
- Testing
- AZD0120
- Where
- 18 sites in United States, Canada and 1 more
- Volunteers
- 91 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Newly Diagnosed Multiple Myeloma (NDMM)
A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6).
The purpose of this study is to measure the efficacy of AZD0120 compared with ASCT in terms of progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative complete…
- Trial name
- DURGA-6 (NCT07735637)
- Testing
- AZD0120, Cyclophosphamide, Fludarabine
- Where
- 114 sites in United States, Australia and 16 more
- Volunteers
- 750 people
- Sponsor
- AstraZeneca
Refractory Immune Cytopenia
BCMA-CD19 CCAR T Cell Treatment of Refractory Immune Thrombocytopenia Associated with Autoimmune Diseases
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 refractory ITP associated with autoimmune disease.
- Trial name
- NCT06787989
- Testing
- BCMA-CD19 cCAR T cells
- Where
- China
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics