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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
Phase I, Dose-ranging, Open-label, Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux™ Therapy, Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34+ Cell Selection, in Patients With Severe Hematologic Malignancies
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significant number of patients no fully HLA-matched donor can be found. The application of partially HLA-matched (haploidentical) family donors, who are virtually always available, has some complications. If there is no T-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of T-cell add-back the risk of graft-versus-host disease is raised.
Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks after the stem cell transplant. This method enables early immune reconstitution while preventing graft-versus-host disease.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 2M4
- Maisonneuve-Rosemont Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS)
- Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient
- Life expectancy of at least 3 months
- Satisfactory performance status (ECOG ≤ 2);
Exclusion Criteria:
- Possibility of performing an allogeneic transplant with an HLA (human leukocyte antigen) matched sibling donor
- Availability of an 6/6 HLA-A, B and DRB1 matched unrelated donor within 2-3 months;
- Pregnancy
- Viral hepatitis (B or C)
- Active serious infectious process
- HIV positivity;
- Systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation
- Prior allogeneic transplantation
- Prior autologous transplantation within twelve months of baseline visit
- Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome
- Active central nervous system (CNS) disease at baseline
- Participation in a trial with an investigational agent within 30 days prior to entry in the study
- Malignant cells in circulating peripheral blood (> 25%)
- Other active malignant disease that would severely limit life expectancy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: L1 (dose 1.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
Experimenteel: L2 (dose 5.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
Experimenteel: L3 (dose 1.3x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
Experimenteel: L4 (dose 3.2x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
Experimenteel: L5 (dose 7.9x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
Experimenteel: L6 (dose 2.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
|
Experimenteel: L7 (dose 5.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
Tijdsspanne: Within 30 days after ATIR infusion
|
Within 30 days after ATIR infusion
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Immune reconstitution
Tijdsspanne: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Rate of disease relapse
Tijdsspanne: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence and severity of graft-versus-host disease
Tijdsspanne: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence of adverse drug reactions
Tijdsspanne: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
|
Incidence and severity of infections
Tijdsspanne: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Denis-Claude Roy, MD, Maisonneuve-Rosemont Hospital, Montréal, Canada
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CR-GVH-001
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