Clinical trials: CD19 CAR-T Cell Therapy
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
Lymphoma Diffuse Large B-cell, Leukemia and Lymphoma
Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
This study is testing Allo-QuadCAR01-T, a new off-the-shelf CAR-T therapy for people with hard-to-treat B-cell cancers. Unlike current CAR-T treatments that use a patient's own cells, this therapy uses donor cells that are ready…
- Conditions
- Lymphoma Diffuse Large B-cell, Leukemia and Lymphoma, Leukemia Relapse, Lymphoma Receiving CAR-T Therapy
- Trial name
- QUADvance (NCT07284433)
- Testing
- Cyclophosphamide (Non-IMP, Lymphodepletion), Fludarabine (Non-IMP, Lymphodepletion), Allo-QuadCAR01-T
- Where
- 13 sites in United States, Germany
- Volunteers
- 178 people
- Sponsor
- AvenCell Therapeutics, Inc.
Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia
Phase I Study of pCAR-19B in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL
This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in adults with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.
- Trial name
- NCT04888442
- Testing
- pCAR-19B cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
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
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.
Systemic Lupus Erythematosus (SLE)
A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
This study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD.
- Trial name
- NCT07444307
- Testing
- QT-019B Cell Injection
- Where
- 3 sites in China
- Volunteers
- 18 people
- Sponsor
- Hangzhou Qihan Biotech Co., Ltd.
Relapsing Multiple Sclerosis (RMS), Progressive Multiple Sclerosis (PMS)
RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis
RESET-MS: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Multiple Sclerosis
- Conditions
- Relapsing Multiple Sclerosis (RMS), Progressive Multiple Sclerosis (PMS), Multiple Sclerosis - Relapsing Remitting, Multiple Sclerosis
- Trial name
- NCT07006805
- Testing
- CABA-201
- Sponsor
- Cabaletta Bio
Lupus Erythematosus, Systemic, Lupus Nephritis
A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at…
- Trial name
- NCT07015983
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 97 sites in United States, Argentina and 14 more
- Volunteers
- 89 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
SLE, Systemic Sclerosis
Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS…
- Conditions
- SLE, Systemic Sclerosis, IIM, NMOSD
- Trial name
- NCT06775912
- Testing
- RD06-05 CART Cell Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Refractory Diffuse Large B-Cell Lymphoma
A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 Treatment in DLBCL Subjects
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of refractory DLBCL
- Trial name
- C-CAR011 (NCT02976857)
- Testing
- C-CAR-011
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shanghai AbelZeta Ltd.
Pemphigus Vulgaris
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
A phase 1/2, open-label, safety and dosing study of autologous CART cells (desmoglein 3 chimeric autoantibody receptor T cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T cells [CABA-201]) in subjects with active…
- Trial name
- NCT04422912
- Testing
- DSG3-CAART, CABA-201
- Where
- 13 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cabaletta Bio
Lymphoblastic Leukemia, Acute Adult
Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia
Evaluate the safety (P-I), pharmacokinetics and anti-tumor effect of immunotherapy of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR) (TBI-1501) for relapsed or refractory CD19+ B-cell…
- Trial name
- TBI-1501 (NCT03155191)
- Testing
- TBI-1501
- Where
- 11 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Takara Bio Inc.
Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood
A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma
This is a single arm, open-label, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety…
- Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed/Refractory B-cell Lymphoma, Childhood
- Trial name
- NCT04204161
- Testing
- CAR-T19/CAR-T22
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shenzhen BinDeBio 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
Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma
Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma
The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen…
- Trial name
- ALPHA (NCT03939026)
- Testing
- ALLO-501, ALLO-647, Fludarabine
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Allogene Therapeutics
Non-hodgkin Lymphoma,B Cell
Treatment of Refractory/Relapsed Non-Hodgkin Lymphoma With TriCAR-T_CD19
This is a single arm, open-label, single-center, phase 1/2 study, to determine the safety and efficacy of TriCAR-T-CD19, an autologous tri-functional anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in…
- Trial name
- Trident19-H (NCT03497533)
- Testing
- TriCAR-T-CD19
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Timmune Biotech Inc.
B-cell Acute Lymphoblastic Leukemia
A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
This is a multi-center, phase I/II trial to evaluate the safety and efficacy of HY004 treatment in Adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
- Trial name
- B-ALL (NCT06009107)
- Testing
- HY004, Cyclophosphamide, Fludarabine Phosphate
- Sponsor
- Juventas Cell Therapy Ltd.
Mantle Cell Lymphoma (MCL)
Frontline Risk-Adapted Optimization of Novel Targeted Immunotherapy Evaluation in High-Risk MCL
FRONTIER is a prospective, single arm, open label, multi-center, Phase II study of MB-CART2019.1 (Zamtocabtagene Autoleucel) therapy as frontline consolidation for high-risk Mantle Cell Lymphoma (MCL) participants
- Trial name
- FRONTIER (NCT07569965)
- Testing
- zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide, Fludarabine
- Volunteers
- 52 people
- Sponsor
- Miltenyi Biomedicine GmbH
Non-Hodgkin Lymphoma (NHL), Acute Lymphoblastic Leukemia (ALL), Adult
Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies
Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies.
- Trial name
- NCT07312630
- Testing
- LV009 Injection Infusion
- Where
- China
- Volunteers
- 19 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Refractory or Relapsed Non-Hodgkin Lymphoma
Study of Safety and Efficacy of C-CAR011 in B-NHL Patients
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
- Trial name
- NCT03154775
- Testing
- C-CAR011
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shanghai AbelZeta Ltd.