Clinical trials: sponsored by Kite, A Gilead Company
Newly Diagnosed Multiple Myeloma
To Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
The goal of this clinical study iMMagine-6 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus autologous stem cell transplant in participants with newly diagnosed multiple myeloma (NDMM).
- Trial name
- iMMagine-6 (NCT07903506)
- Testing
- Anitocabtagene Autoleucel, Isatuximab, Bortezomib
- Volunteers
- 750 people
- Sponsor
- Kite, A Gilead Company
Relapsed and/or Refractory B-cell Lymphoma
Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma
The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.
- Trial name
- PALISADES-1 (NCT04989803)
- Testing
- Cyclophosphamide, Fludarabine, KITE-363
- Where
- 36 sites in United States, Australia and 4 more
- Volunteers
- 247 people
- Sponsor
- Kite, A Gilead Company
Relapsed or Refractory Large B-cell Lymphoma
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after one prior line of therapy.
- Trial name
- NCT07479797
- Testing
- KITE-753, Axicabtagene Ciloleucel, Fludarabine
- Where
- 42 sites in United States, Australia and 7 more
- Volunteers
- 550 people
- Sponsor
- Kite, A Gilead Company
Muscular Diseases, Neuromuscular Manifestations
Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis…
- Conditions
- Muscular Diseases, Neuromuscular Manifestations, Autoimmune, Autoimmune Diseases
- Trial name
- NCT06626919
- Testing
- anito-cel, Cyclophosphamide, Fludarabine
- Where
- 14 sites in United States
- Volunteers
- 30 people
- Sponsor
- Kite, A Gilead Company
Newly Diagnosed Multiple Myeloma
A Trial to Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Standard of Care in Newly Diagnosed Multiple Myeloma
The goal of this clinical study iMMagine-4 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus standard of care therapy (SOCT) in participants with newly diagnosed multiple myeloma (NDMM) who…
- Trial name
- iMMagine-4 (NCT07887672)
- Testing
- Anitocabtagene autoleucel, Daratumumab, Bortezomib
- Volunteers
- 600 people
- Sponsor
- Kite, A Gilead Company
Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis
Study of KITE-363 in Participants With Autoimmune Neurologic Diseases That Did Not Respond to Usual Treatment
This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with…
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis, Multiple Sclerosis
- Trial name
- HERMOSA-2 (NCT07304154)
- Testing
- KITE-363, Fludarabine, Cyclophosphamide
- Where
- 10 sites in United States, Australia and 1 more
- Volunteers
- 57 people
- Sponsor
- Kite, A Gilead Company
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome.
Master Protocol: The main goal of this master clinical trial study is to assesses the safety, tolerability, pharmacokinetic (PK), Pharmacodynamic (PD) in participants with relapsed or refractory acute myeloid leukemia (AML) or…
- Trial name
- NCT05457010
- Testing
- SPRX002, ARC-T Cells, Cyclophosphamide
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Kite, A Gilead Company
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of KITE-363 in Participants With Refractory Autoimmune Diseases
This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy
- Trial name
- NCT07038447
- Testing
- KITE-363, Fludarabine, Cyclophosphamide
- Where
- 10 sites in United States, Australia and 2 more
- Volunteers
- 52 people
- Sponsor
- Kite, A Gilead Company
Solid and Hematological Malignancies, Autoimmune Diseases
Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies
The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, anitocabtagene…
- Trial name
- NCT05041309
- Testing
- Axicabtagene Ciloleucel, Brexucabtagene Autoleucel, Anitocabtagene autleucel
- Where
- 91 sites in United States, Australia and 12 more
- Volunteers
- 1,500 people
- Sponsor
- Kite, A Gilead Company
Lymphomas Non-Hodgkin's B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma
A Study to Investigate Safety of INT2104 Infusions in Participants Aged 18 Years of Age and Older Who Have B-cell Cancers That Came Back After Previous Treatment
The purpose of this first-in-human study is to evaluate the safety and tolerability of INT2104 when administered to humans in a broad population of participants with refractory/relapsing B-cell malignancies.
- Trial name
- INVISE (NCT06539338)
- Testing
- INT2104
- Where
- 3 sites in Australia, Spain
- Volunteers
- 10 people
- Sponsor
- Kite, A Gilead Company
Relapsed/Refractory Large B-cell Lymphoma
Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma
This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory…
- Trial name
- NCT06079164
- Testing
- KITE-197, Cyclophosphamide, Fludarabine
- Where
- 11 sites in United States, Australia and 1 more
- Volunteers
- 21 people
- Sponsor
- Kite, A Gilead Company
Relapsed/Refractory Mantle Cell Lymphoma
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL) who have not previously received Bruton's…
- Trial name
- ZUMA-2 (NCT04880434)
- Testing
- Fludarabine, Cyclophosphamide, Brexucabtagene autoleucel
- Where
- 40 sites in United States, France and 4 more
- Volunteers
- 95 people
- Sponsor
- Kite, A Gilead Company
Multiple Myeloma
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of…
- Trial name
- iMMagine-3 (NCT06413498)
- Testing
- Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine
- Where
- 117 sites in United States, Australia and 13 more
- Volunteers
- 452 people
- Sponsor
- Kite, A Gilead Company
Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
The goal of this clinical study is to learn more about KTE-X19, and how safe and effective it is in adult Japanese participants with relapsed/refractory (r/r) Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic…
- Trial name
- JKART-1 (NCT06253663)
- Testing
- KTE-X19, Cyclophosphamide, Fludarabine
- Where
- 9 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Kite, A Gilead Company
Large B-cell Lymphoma, Follicular Lymphoma
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.
- Trial name
- NCT05776160
- Testing
- Axicabtagene Ciloleucel
- Where
- 128 sites in United States, Japan
- Sponsor
- Kite, A Gilead Company
High-risk Large B-cell Lymphoma (LBCL)
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
- Trial name
- ZUMA-23 (NCT05605899)
- Testing
- Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine
- Where
- 85 sites in United States, Australia and 10 more
- Volunteers
- 300 people
- Sponsor
- Kite, A Gilead Company
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia…
- Trial name
- ZUMA-4 (NCT02625480)
- Testing
- Brexucabtagene Autoleucel (KTE-X19), Fludarabine, Cyclophosphamide
- Where
- 30 sites in United States, Belgium and 9 more
- Volunteers
- 95 people
- Sponsor
- Kite, A Gilead Company
Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.
- Trial name
- NCT05776134
- Testing
- Brexucabtagene Autoleucel
- Where
- 44 sites in United States
- Sponsor
- Kite, A Gilead Company
Relapsed/Refractory Mantle Cell Lymphoma
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
- Trial name
- ZUMA-2 (NCT02601313)
- Testing
- brexucabtagene autoleucel, Cyclophosphamide, Fludarabine
- Where
- 32 sites in United States, France and 2 more
- Volunteers
- 105 people
- Sponsor
- Kite, A Gilead Company
Relapsed/Refractory Waldenstrom Macroglobulinemia, Relapsed/Refractory Richter Transformation
Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
Master protocol: The goal of this master clinical study is to test how well the study drug, brexucabtagene autoleucel, works in participants with rare B-cell malignancies: relapsed/refractory Waldenstrom macroglobulinemia (r/r…
- Conditions
- Relapsed/Refractory Waldenstrom Macroglobulinemia, Relapsed/Refractory Richter Transformation, Relapsed/Refractory Burkitt Lymphoma, Relapsed/Refractory Hairy Cell Leukemia
- Trial name
- ZUMA-25 (NCT05537766)
- Testing
- Brexucabtagene Autoleucel, Cyclophosphamide, Fludarabine
- Where
- 26 sites in United States, Austria and 6 more
- Volunteers
- 19 people
- Sponsor
- Kite, A Gilead Company