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18 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
siplizumab (TCD601) / ITBMed
2020-000419-56: A 12-Month Clinical Research Study to evaluate a new investigational medication (siplizumab) compared to another medication (anti-thymocyte globulin) for the prevention of rejection in patients who have received a kidney transplant.

Ongoing
2
40
Europe
siplizumab, TCD601, Concentrate for solution for infusion, Powder for solution for infusion, Thymoglobuline
ITB-MED AB, ITB-MED AB
renal transplantation, kidney transplantation, Body processes [G] - Immune system processes [G12]
 
 
NCT06365437: A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation

Completed
2
33
Europe
TCD601, Siplizumab, Tacrolimus (TAC), Corticosteroids (CS), Mycophenolate Mofetil (MMF), ATG
ITB-Med LLC
Kidney Transplantation
12/24
12/24
2021-001680-24: A study to investigate whether treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.

Ongoing
2
12
Europe
Siplizumab, TCD601, Concentrate for solution for infusion
ITB-MED AB, IBT-MED AB
Prophylaxis against liver allograft rejection following toleranceinduction, Liver failure, Body processes [G] - Immune system processes [G12]
 
 
2022-001713-39: A one year, randomized, placebo-controlled study of TCD601 (siplizumab) in newly diagnosed patients with Type 1 diabetes

Not yet recruiting
2
96
Europe
Siplizumab, TCD601, Solution for infusion, Solution for injection
ITB-MED AB, ITB-MED AB
New onset Type I Diabetes, New onset Type I Diabetes, Diseases [C] - Hormonal diseases [C19]
 
 
NCT04803058: A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)

Active, not recruiting
2
18
US, RoW
TCD601
ITB-Med LLC
Kidney Transplantation
03/27
03/30
STRIDE, NCT06025110: A Study of TCD601 (siplizumab) in New Onset Type 1 Diabetes Patients

Active, not recruiting
2
96
Europe
TCD601, Placebo
ITB-Med LLC
Diabetes Mellitus, Type 1
01/27
01/27
ASCEND, NCT05669001: A Study of TCD601 in de Novo Renal Transplant Recipients

Active, not recruiting
2
90
US
TCD601, siplizumab, belatacept, ATG, antithymocyte globulin, TAC, tacrolimus, MPA, mycophenolic acid, Corticosteroids
ITB-Med LLC
Renal Transplantation
07/25
10/26
NCT04311632: A Dose Escalation Study in de Novo Renal Transplantation

Completed
2
13
US
TCD601, Tacrolimus (TAC), Corticosteroids (CS), Mycophenolate Mofetil (MMF), ATG
ITB-Med LLC
Kidney Transplantation
10/23
10/23
NCT06019507: A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation

Active, not recruiting
2
12
Europe
TCD601, siplizumab, Cyclophosphamide, TAC, Tacrolimus, MMF, Mycophenolate Mofetil, Corticosteroids
ITB-Med LLC
Liver Transplantation
06/26
06/29
NCT04803006: A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)

Active, not recruiting
2
18
US
TCD601
ITB-Med LLC
Kidney Transplantation
07/27
07/30
NCT05900401: Delayed Tolerance Through Mixed Chimerism

Active, not recruiting
1/2
20
US
Bone Marrow Transplant, Peripheral Blood Stem Cell Collection, Fludarabine, Cyclophosphamide, Rituximab, Siplizumab
Massachusetts General Hospital, Ossium Health, Inc., ITB-Med LLC
Kidney Failure, Kidney Transplant; Complications, Chimera
12/28
12/30
DESIGNATE, NCT05574335: Siplizumab in T1DM

Active, not recruiting
1/2
120
US
Siplizumab, TCD 601
National Institute of Allergy and Infectious Diseases (NIAID)
Type 1 Diabetes Mellitus
05/25
10/25
CD2 SCD, NCT06078696: Siplizumab for Sickle Cell Disease Transplant

Recruiting
1/2
18
US
Siplizumab, TCD601 (Siplizumab), Exchange Transfusion, Total Body Irradiation, TBI, Stem Cell Infusion, Cyclophosphamide 50mg, Cytoxan, Cytoxan Lyophilized, Mesna, Mesnex, Sirolimus Oral Tablet, Rapamycin, Rapamune, Rituximab or Biosimilar, Riabni, Rituxan, Ruxience, Truxima
Columbia University, ITB-Med LLC
Anemia, Sickle Cell
07/28
07/29
AURORA, NCT06453668: A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients

Active, not recruiting
1
48
Europe
TCD601, siplizumab
ITB-Med LLC
ALS
11/26
11/26
SET-SAIL, NCT06455280: A Study of SIPLIZUMAB in AILD and LT Patients

Recruiting
1
8
US
Siplizumab
Elizabeth C. Verna, ITB-Med LLC
Autoimmune Liver Disease, Liver Transplant Disorder, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, End Stage Liver DIsease, Cirrhosis, Liver
12/25
03/26
NCT04540380: Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH

Active, not recruiting
1
20
US
Rituximab, Fludarabine, Cyclophosphamide, Thymic irradiation and Siplizumab, Combined bone marrow and kidney transplant
Massachusetts General Hospital
Renal Failure
01/27
06/27
NCT06326476: An Open-label, Time-lagged, Dose-escalation Study to Evalaute the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa.

Recruiting
1
12
US
Siplizumab
University of Alabama at Birmingham, ITB-Med LLC
Hidradenitis Suppurativa
12/26
07/27
NCT06972069: Tolerance Through Mixed Chimerism (Sip-Tego)

Not yet recruiting
1
12
US
Combined Kidney/Bone Marrow Transplant, Donation of Kidney / Bone Marrow, Conditioning Regimen (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart)
Tatsuo Kawai, MD, PhD, Eledon Pharmaceuticals, ITB-Med LLC
Kidney Failure, Transplant Recipient (Kidney), Transplant Tolerance, Immunosuppresion, Immunosuppression After Kidney Transplantation
12/30
12/30
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
siplizumab (TCD601) / ITBMed
2020-000419-56: A 12-Month Clinical Research Study to evaluate a new investigational medication (siplizumab) compared to another medication (anti-thymocyte globulin) for the prevention of rejection in patients who have received a kidney transplant.

Ongoing
2
40
Europe
siplizumab, TCD601, Concentrate for solution for infusion, Powder for solution for infusion, Thymoglobuline
ITB-MED AB, ITB-MED AB
renal transplantation, kidney transplantation, Body processes [G] - Immune system processes [G12]
 
 
NCT06365437: A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation

Completed
2
33
Europe
TCD601, Siplizumab, Tacrolimus (TAC), Corticosteroids (CS), Mycophenolate Mofetil (MMF), ATG
ITB-Med LLC
Kidney Transplantation
12/24
12/24
2021-001680-24: A study to investigate whether treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.

Ongoing
2
12
Europe
Siplizumab, TCD601, Concentrate for solution for infusion
ITB-MED AB, IBT-MED AB
Prophylaxis against liver allograft rejection following toleranceinduction, Liver failure, Body processes [G] - Immune system processes [G12]
 
 
2022-001713-39: A one year, randomized, placebo-controlled study of TCD601 (siplizumab) in newly diagnosed patients with Type 1 diabetes

Not yet recruiting
2
96
Europe
Siplizumab, TCD601, Solution for infusion, Solution for injection
ITB-MED AB, ITB-MED AB
New onset Type I Diabetes, New onset Type I Diabetes, Diseases [C] - Hormonal diseases [C19]
 
 
NCT04803058: A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)

Active, not recruiting
2
18
US, RoW
TCD601
ITB-Med LLC
Kidney Transplantation
03/27
03/30
STRIDE, NCT06025110: A Study of TCD601 (siplizumab) in New Onset Type 1 Diabetes Patients

Active, not recruiting
2
96
Europe
TCD601, Placebo
ITB-Med LLC
Diabetes Mellitus, Type 1
01/27
01/27
ASCEND, NCT05669001: A Study of TCD601 in de Novo Renal Transplant Recipients

Active, not recruiting
2
90
US
TCD601, siplizumab, belatacept, ATG, antithymocyte globulin, TAC, tacrolimus, MPA, mycophenolic acid, Corticosteroids
ITB-Med LLC
Renal Transplantation
07/25
10/26
NCT04311632: A Dose Escalation Study in de Novo Renal Transplantation

Completed
2
13
US
TCD601, Tacrolimus (TAC), Corticosteroids (CS), Mycophenolate Mofetil (MMF), ATG
ITB-Med LLC
Kidney Transplantation
10/23
10/23
NCT06019507: A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation

Active, not recruiting
2
12
Europe
TCD601, siplizumab, Cyclophosphamide, TAC, Tacrolimus, MMF, Mycophenolate Mofetil, Corticosteroids
ITB-Med LLC
Liver Transplantation
06/26
06/29
NCT04803006: A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)

Active, not recruiting
2
18
US
TCD601
ITB-Med LLC
Kidney Transplantation
07/27
07/30
NCT05900401: Delayed Tolerance Through Mixed Chimerism

Active, not recruiting
1/2
20
US
Bone Marrow Transplant, Peripheral Blood Stem Cell Collection, Fludarabine, Cyclophosphamide, Rituximab, Siplizumab
Massachusetts General Hospital, Ossium Health, Inc., ITB-Med LLC
Kidney Failure, Kidney Transplant; Complications, Chimera
12/28
12/30
DESIGNATE, NCT05574335: Siplizumab in T1DM

Active, not recruiting
1/2
120
US
Siplizumab, TCD 601
National Institute of Allergy and Infectious Diseases (NIAID)
Type 1 Diabetes Mellitus
05/25
10/25
CD2 SCD, NCT06078696: Siplizumab for Sickle Cell Disease Transplant

Recruiting
1/2
18
US
Siplizumab, TCD601 (Siplizumab), Exchange Transfusion, Total Body Irradiation, TBI, Stem Cell Infusion, Cyclophosphamide 50mg, Cytoxan, Cytoxan Lyophilized, Mesna, Mesnex, Sirolimus Oral Tablet, Rapamycin, Rapamune, Rituximab or Biosimilar, Riabni, Rituxan, Ruxience, Truxima
Columbia University, ITB-Med LLC
Anemia, Sickle Cell
07/28
07/29
AURORA, NCT06453668: A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients

Active, not recruiting
1
48
Europe
TCD601, siplizumab
ITB-Med LLC
ALS
11/26
11/26
SET-SAIL, NCT06455280: A Study of SIPLIZUMAB in AILD and LT Patients

Recruiting
1
8
US
Siplizumab
Elizabeth C. Verna, ITB-Med LLC
Autoimmune Liver Disease, Liver Transplant Disorder, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, End Stage Liver DIsease, Cirrhosis, Liver
12/25
03/26
NCT04540380: Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH

Active, not recruiting
1
20
US
Rituximab, Fludarabine, Cyclophosphamide, Thymic irradiation and Siplizumab, Combined bone marrow and kidney transplant
Massachusetts General Hospital
Renal Failure
01/27
06/27
NCT06326476: An Open-label, Time-lagged, Dose-escalation Study to Evalaute the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa.

Recruiting
1
12
US
Siplizumab
University of Alabama at Birmingham, ITB-Med LLC
Hidradenitis Suppurativa
12/26
07/27
NCT06972069: Tolerance Through Mixed Chimerism (Sip-Tego)

Not yet recruiting
1
12
US
Combined Kidney/Bone Marrow Transplant, Donation of Kidney / Bone Marrow, Conditioning Regimen (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart)
Tatsuo Kawai, MD, PhD, Eledon Pharmaceuticals, ITB-Med LLC
Kidney Failure, Transplant Recipient (Kidney), Transplant Tolerance, Immunosuppresion, Immunosuppression After Kidney Transplantation
12/30
12/30

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