Clinical trials: CD19 CAR-T Cell Therapy
Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL
A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
This is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
- Conditions
- Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL, Refractory Acute Lymphoblastic Leukemia
- Trial name
- NCT05334823
- Testing
- pCAR-19B cells
- Where
- 16 sites in China
- Volunteers
- 100 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Systemic Lupus Erythematosus, Lupus Nephritis
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06544330
- Testing
- SYNCAR-001, STK-009
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Synthekine
Non-hodgkin Lymphoma,B Cell
The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.
- Trial name
- NCT05741359
- Testing
- CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection
- Where
- 3 sites in China
- Volunteers
- 18 people
- Sponsor
- Bioray Laboratories
Non-Hodgkin Lymphoma
Treatment of Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy
This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Non-Hodgkin lymphoma treatment.
- Trial name
- NCT03790891
- Testing
- CD19-TriCAR-T/SILK
- Where
- 3 sites in China
- Volunteers
- 12 people
- Sponsor
- Timmune Biotech Inc.
Generalized Myasthenia Gravis (gMG)
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis
- Trial name
- NCT06359041
- Testing
- CABA-201
- Where
- 17 sites in United States
- Volunteers
- 24 people
- Sponsor
- Cabaletta Bio
Autoimmune Diseases
CAR-T Therapy for Refractory Autoimmune Diseases
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases.
- Trial name
- NCT07059169
- Testing
- JY231 (JY231 injection)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- LiangZou
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
This is a Phase 1b/2, multicenter, open-label, study of JNJ-90014496, an autologous dual targeting chimeric antigen receptor (CAR) T-cell therapy targeting both cluster of differentiation (CD) CD20 and CD19, for the treatment of…
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
- Trial name
- NCT05421663
- Testing
- JNJ-90014496
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 166 people
- Sponsor
- Janssen Research & Development, LLC
Lupus Erythematosus, Systemic Lupus Erythematosus
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.
- Conditions
- Lupus Erythematosus, Systemic Lupus Erythematosus, SLE (Systemic Lupus), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06294236
- Testing
- SC291
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sana Biotechnology
Idiopathic Inflammatory Myopathy, Dermatomyositis
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
- Conditions
- Idiopathic Inflammatory Myopathy, Dermatomyositis, Anti-Synthetase Syndrome, Immune-Mediated Necrotizing Myopathy
- Trial name
- NCT06154252
- Testing
- CABA-201 following preconditioning with fludarabine and cyclophosphamide
- Where
- 38 sites in United States, Germany and 2 more
- Volunteers
- 74 people
- Sponsor
- Cabaletta Bio
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
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Non-hodgkin Lymphoma
Clinical Trial of HY004 Cell Injection in the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
This is a multi-center, open-label, single-arm, phase I/II trial to evaluate the safety and efficacy of HY004 treatment in Adult patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (r/r B-NHL).
- Trial name
- NCT06005649
- Testing
- HY004
- Sponsor
- Juventas Cell Therapy Ltd.
Follicular Lymphoma (FL)
Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma
This Phase II, multi-center, single-arm, open-label study evaluates the efficacy and safety of TC011, a CD19-targeted CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a).
- Trial name
- TC011_FL_201 (NCT07360288)
- Testing
- TC011 single-arm
- Volunteers
- 40 people
- Sponsor
- TICAROS Co., Ltd.
Refractory Diffuse Large B-cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma
Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy
This is a multicenter Phase 1b study evaluating the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard of care CD19 chimeric antigen receptor T-cell (CAR T-cell) therapy for…
- Conditions
- Refractory Diffuse Large B-cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma, DLBCL Arising From Follicular Lymphoma
- Trial name
- NCT05075603
- Testing
- Efineptakin alfa, Tisagenlecleucel, Axicabtagene ciloleucel
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- NeoImmuneTech
Lupus Nephritis, Systemic Lupus Erythematosus
A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Systemic Lupus Erythematosus
The purpose of the study is to evaluate the safety and preliminary efficacy of ATA3219 for treatment of participants with lupus nephritis (LN) following lymphodepletion (LD) and in participants with extrarenal systemic lupus…
- Trial name
- NCT06429800
- Testing
- ATA3219
- Where
- United States
- Sponsor
- Atara Biotherapeutics
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal…
- Conditions
- Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy, Systemic Sclerosis
- Trial name
- RESOLUTION (NCT07085104)
- Testing
- ALLO-329, Cyclophosphamide, Fludarabine
- Where
- 18 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Allogene Therapeutics
B-cell Acute Lymphoblastic Leukemia
A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
- Trial name
- NCT05667506
- Testing
- single dose of CNCT19
- Where
- 9 sites in China
- Volunteers
- 47 people
- Sponsor
- Juventas Cell Therapy Ltd.
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
Relapsed B Cell Acute Lymphoblastic Leukemia (ALL), Refractory B Cell Acute Lymphoblastic Leukemia (ALL)
CD19 Targeted CAR T Cell Therapy in Patients With Relapsed/ Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
This is a single-arm, open-label, phase I study (safety and dose escalation) of autologous Chimeric Antigen Receptor (CAR) T-cells targeting CD19 in patients with relapsed/refractory B cell acute lymphoblastic leukemia (ALL).
- Trial name
- NCT04653493
- Testing
- CD19 CAR engineered autologous T-cells, Cyclophosphamide, Fludarabine
- Where
- 2 sites in Iran
- Volunteers
- 22 people
- Sponsor
- Sabz Biomedicals
Non-hodgkin Lymphoma,B Cell
Universal CAR-T Cell Therapy for NHL
This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.
- Trial name
- NCT07248163
- Testing
- BRL-301
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Bioray Laboratories