Clinical trials: Haploidentical Stem Cell Transplantation
Graft -Versus-host-disease, aGVHD
BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation
A Phase IIb open label study evaluates the safety and efficacy of repeat doses of BPC2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following…
- Conditions
- Graft -Versus-host-disease, aGVHD, Haploidentical Stem Cell Transplantation, cGVHD
- Trial name
- NCT07246031
- Testing
- BPC-2001
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- BioPhoenix Co., Ltd.
Myeloid Leukemia, Lymphoblastic Leukemia
Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
The purpose of this study is to determine whether the administration of a donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted stem cell transplant from a related…
- Conditions
- Myeloid Leukemia, Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma
- Trial name
- NCT00967343
- Testing
- Donor lymphocyte preparation depleted of host functional alloreactive T-cells
- Where
- 15 sites in United States, Belgium and 5 more
- Volunteers
- 40 people
- Sponsor
- Kiadis Pharma
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation
Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT02188290
- Where
- 9 sites in United States, Belgium and 4 more
- Volunteers
- 178 people
- Sponsor
- Kiadis Pharma
Hematologic Diseases, Hematologic Malignancies
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
The purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related…
- Trial name
- NCT00993486
- Testing
- Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)
- Where
- Canada
- Volunteers
- 19 people
- Sponsor
- Kiadis Pharma
Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.
- Conditions
- Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis, Inherited Bone Marrow Failure Syndrome, Hemoglobinopathies
- Trial name
- NCT02231710
- Testing
- BPX-501 and Rimiducid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Bellicum Pharmaceuticals
AML, MDS
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity…
- Trial name
- ALLOHA-2 (NCT07702578)
- Testing
- TSC-101, Control
- Where
- 26 sites in United States
- Volunteers
- 310 people
- Sponsor
- TScan Therapeutics, Inc.
AML, MDS
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA)
This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating…
- Trial name
- NCT05473910
- Testing
- SOC + TSC-101, Control, SOC + TSC-100
- Where
- 21 sites in United States
- Volunteers
- 310 people
- Sponsor
- TScan Therapeutics, 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
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
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer
The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- Trial name
- HATCY (NCT02999854)
- Testing
- ATIR101, Cyclophosphamide, T-cell depleted HSCT from a related, haploidentical donor
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 63 people
- Sponsor
- Kiadis Pharma
Hematological Malignancies
M-2018-334 in Hematological Malignancies
This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.
- Trial name
- HAPLO2022 (NCT06225050)
- Testing
- CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Miltenyi Biomedicine GmbH
Hurler Syndrome, Inherited Metabolic Disorder
BPX-501 T Cells Infused Post Stem Cell Transplant in Pediatrics With Non-Malignant Disorders Ineligible for BPU004 Study
Providing access of BPX-501 gene modified T cells and rimiducid to pediatric patients who do not meet the eligibility criteria of the BP-U-004 study.
- Conditions
- Hurler Syndrome, Inherited Metabolic Disorder, Lysosomal Storage Disorder, Metachromatic Leukodystrophy
- Trial name
- NCT03639844
- Testing
- rivogenlecleucel, rimiducid
- Where
- 2 sites in United States
- Sponsor
- Bellicum Pharmaceuticals
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study of Haplo-HSCT + Rivogenlecleucel vs Haplo-HSCT + Post Transplant Cyclophosphamide in Patients With AML or MDS
This study compares the safety and effectiveness of giving rivogenlecleucel (BPX-501 T cells) to patients with AML or MDS post haploidentical hematopoietic stem cell transplant compared to post-transplant cyclophosphamide.
- Trial name
- THRIVE (NCT03699475)
- Testing
- rivogenlecleucel, rimiducid, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Bellicum Pharmaceuticals
Hematological Malignancies
Infusion of Donor Lymphocytes Transduced With the Suicide Gene HSV TK in Patients With Haematological Malignancies
The aim of the study is to obtain immune reconsitutuion as well as reduction of infective episodes and disease relapse in patient with haematological malignancies who underwent SCT(and subsequent T lymphocytes infusions) and…
- Trial name
- NCT00423124
- Testing
- HSV-TK
- Where
- 8 sites in Germany, Greece and 3 more
- Volunteers
- 57 people
- Sponsor
- AGC Biologics S.p.A.