Clinical trials: Immune Reconstitution
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
The purpose of this study is to determine whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT02500550
- Testing
- ATIR101, Haploidentical hematopoietic stem cell transplantation (HSCT), TBI regime
- Where
- 11 sites in Belgium, Canada and 4 more
- Volunteers
- 15 people
- Sponsor
- Kiadis Pharma
Human Immunodeficiency Virus; HIV
An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART
The purpose of this study is to study the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs)…
- Trial name
- NCT01541085
- Testing
- Darunavir/Ritonavir (DRV/r), Efavirenz (EFV)
- Volunteers
- 33 people
- Sponsor
- Janssen-Cilag S.p.A.
Cord Blood Transplant, Hematologic Malignancy
Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Pediatric Patients Undergoing Single or Double Umbilical Cord Blood Transplantation
Engraftment failure is a major obstacle to the success of cord blood transplantation in children with malignancies and inherited metabolic disorders, despite the fact that they receive relatively high doses of nucleated cells…
- Conditions
- Cord Blood Transplant, Hematologic Malignancy, Inherited Metabolic Disease
- Trial name
- NCT01554254
- Testing
- TXA127
- Where
- United States
- Sponsor
- Tarix Pharmaceuticals
AML, CML
Safety Study of IL-7 in Recipients of a Hemopoietic Stem Cell Transplant Peripheral Blood Stem Cell Transplant
This is a phase I inter-patient dose escalation open labeled study assessing multiple doses of CYT107 in patients of at least 15 years of age, who are recipients of HLA matched ex vivo T cell depleted bone marrow or peripheral…
- Conditions
- AML, CML, MDS
- Trial name
- NCT00684008
- Testing
- CYT107 - Recombinant glycosylated human interleukin 7., rhIL-7 (CYT107)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Cytheris, Inc.
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells (ATIR) in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
The purpose of this study is to determine whether ATIR is safe and effective in reducing transplant-related mortality and improving overall survival, when infused in patients with a hematologic malignancy following a T-cell…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT01794299
- Testing
- ATIR
- Where
- 8 sites in Belgium, Canada and 2 more
- Volunteers
- 31 people
- Sponsor
- Kiadis Pharma
Atopic Dermatitis
Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis
Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of…
- Trial name
- NCT00367393
- Testing
- Pimecrolimus cream 1%
- Where
- Germany
- Volunteers
- 41 people
- Sponsor
- Novartis
Cancer, Neoplasms
Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer
This study evaluates four different doses of ACIT-1 for safety and for the ability to raise effective anti-cancer immune responses in patients with pancreatic and other cancers.
- Trial name
- NCT03096093
- Testing
- ACIT-1
- Where
- 2 sites in United Kingdom
- Volunteers
- 34 people
- Sponsor
- Cancer Vaccines Limited
ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia)
PRAISE-IR Versus CIBMTR Controls
The rationale to conduct this RWE study is to provide data to support the safety of CD34 selected grafts versus T replete PBSC transplants to address concerns about increased TRM in CD34 selected graft recipients.
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
- Trial name
- NCT07717164
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Miltenyi Biomedicine GmbH
Severe Sepsis With Septic Shock
A Study of IL-7 to Restore Absolute Lymphocyte Counts in Sepsis Patients
A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in sepsis patients; IRIS-7B (Immune…
- Trial name
- IRIS-7-B (NCT02640807)
- Testing
- Interleukin-7
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Revimmune
Hematologic Malignancies
Efficacy Study of a TXA127 to Reduce Acute Graft-vs-Host Disease in Subjects Undergoing Double Umbilical Cord Blood Transplantation
The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing double umbilical cord blood transplantation (UCBT).
- Trial name
- NCT01882374
- Testing
- TXA127
- Where
- United States
- Sponsor
- Tarix Pharmaceuticals
Immune Reconstitution Inflammatory Syndrome, Leukoencephalopathy, Progressive Multifocal
Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)
The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course…
- Trial name
- IRIS (NCT01211665)
- Testing
- Methylprednisolone, Prednisolone
- Where
- 3 sites in United States, Germany
- Volunteers
- 3 people
- Sponsor
- Biogen
AIDS Virus, Disorder of Immune Reconstitution
Mesenchymal Stem Cells for Immune Non-responder Patients With HIV Infection
The goal of this clinical trial is to explore the effect of mesenchymal stem cell therapy on immune non-responder patients. The main questions it aims to answer are: 1.
- Trial name
- NCT05872659
- Testing
- normal saline, Mesenchymal stem cells
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shandong Qilu Cell Therapy Engineering Technology Co., Ltd
Hematological Malignancies
Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell…
- Trial name
- NCT04959903
- Testing
- Allogeneic T cell progenitors, cultured ex-vivo
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Smart Immune SAS
Chronic Graft Versus Host Disease
Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)
The primary objective of this study is to evaluate the effect of entospletinib (ENTO) on the best overall response rate in adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic corticosteroids…
- Trial name
- NCT02701634
- Testing
- ENTO
- Where
- 30 sites in United States, Canada and 5 more
- Volunteers
- 66 people
- Sponsor
- Gilead Sciences
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera
The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants with lymphopenia.
- Trial name
- Lympho-TEC (NCT04756687)
- Testing
- Dimethyl fumarate
- Where
- 32 sites in France
- Volunteers
- 1,507 people
- Sponsor
- Biogen
HIV Infections, Lymphopenia
Safety Study of IL-7 in HIV-infected Patients (Inspire)
This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV infection. Animal studies have shown that IL-7 can improve the function and number of infection-fighting cells called T lymphocytes, or T…
- Trial name
- NCT00477321
- Testing
- CYT 107
- Where
- 8 sites in United States, Canada and 2 more
- Volunteers
- 30 people
- Sponsor
- Cytheris SA
COVID-19, Lymphocytopenia
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I )
Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients
- Trial name
- ILIAD-7-US-I (NCT04442178)
- Testing
- CYT107
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Revimmune
COVID-19, Lymphocytopenia
InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection UK Cohort
Comparison of the effects of CYT107 vs Placebo administered IM at 10µg/kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.
- Trial name
- ILIAD-7-UK (NCT04379076)
- Testing
- Interleukin-7
- Where
- 13 sites in United Kingdom
- Volunteers
- 35 people
- Sponsor
- Revimmune
COVID-19, Lymphocytopenia
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection FR BL Cohort
Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/ kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.
- Trial name
- ILIAD-7-FR (NCT04407689)
- Testing
- Interleukin-7
- Where
- 6 sites in France
- Volunteers
- 34 people
- Sponsor
- Revimmune
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
A Phase II Trial for MOR Antagonism With Axelopran to Enhance Immunotherapy in Head and Neck Cancer
This Phase 2, open-label, multicenter study will evaluate the safety and preliminary efficacy of axelopran in combination with pembrolizumab in patients with PD-L1 positive recurrent or metastatic head and neck squamous cell…
- Trial name
- MORALE-HN01 (NCT07662720)
- Testing
- axelopran, Pembolizumab
- Volunteers
- 18 people
- Sponsor
- Glycyx Therapeutics