Gamma Delta T-celinfusie voor AML met een hoog risico op terugval na Allo HCT
Fase 1/1b-studie met donor γδ T-cel-infusie voor de behandeling van patiënten met acute myeloïde leukemie met een hoog risico op terugval na allogene hematopoëtische stamceltransplantatie
The purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Florida
-
Tampa, Florida, Verenigde Staten, 33612
- Moffitt Cancer Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) or the treatment ELN 2017 adverse risk AML
- Have < 5% blasts in bone marrow by morphology at the time of transplantation. Patients with pre-alloHCT or post-alloHCT flow cytometric or molecular evidence of MRD are allowed
- Karnofsky performance status (KPS) ≥ 70% during the study screening.
- Free of symptomatic congestive heart failure or uncontrolled arrhythmia
- Adequate organ function as defined per protocol
- Negative serum pregnancy test
- Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for at least 30 days following study treatment (T-cell infusion); should a woman subject or female partner of a male subject become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion Criteria:
- Current use of concomitant systemic glucocorticoid at the time of γδ T-cell infusion for any reason will not be allowed in order to avoid their immunosuppressive effects on γδ T-cell function.
- Active grade II-IV acute GVHD (patients with prior GVHD should be off prednisone for at least 14 days prior to infusion of the study cell product).
- Uncontrolled serious infection.
- Morphologic relapse of leukemia at any timepoint after HCT.
- Active central nervous system malignancy.
- Pregnancy or lactation.
- Treatment with another investigational drug or other intervention within 14 days of T-cell infusion
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Dose Level -1
Dose Level -1 may be used as a de-escalation dose level due to Dose Limiting Toxicities (DLTs) from Dose Level 1 Participants will receive 1.0 x 106 cells/kg (0.75-1.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion |
Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT. |
|
Experimenteel: Dose Level 1
Participants will receive 5.0 x 106 cells/kg (3.75-6.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion |
Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT. |
|
Experimenteel: Dose Level 2
Participants will receive 2.5 x 107 cells/kg (1.875-3.125 x 107 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion |
Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT. |
|
Experimenteel: Dose Level 3
Participants will receive 1.0 x 108 cells/kg (0.75-1.25 x 108 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion |
Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT. |
|
Experimenteel: Treatment at Maximum Tolerated Dose
Participants will receive Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells at the dose determined to be the Maximum Tolerated Dose, administered as a single infusion |
Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Maximum Tolerated Dose
Tijdsspanne: Up to 12 months
|
Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor γδ T-cells. |
Up to 12 months
|
|
Dose Expansion: Leukemia Free Survival
Tijdsspanne: Up to 12 months
|
Leukemia-free survival is defined as the time from the date of start of treatment to the date of relapse of AML or death from any cause |
Up to 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants with Graft Versus Host Disease (GVHD)
Tijdsspanne: at 6 weeks
|
Number of participants with grade II-IV and III-IV acute GVHD within 6 weeks after infusion of Gamma T cells |
at 6 weeks
|
|
Overall Survival (OS)
Tijdsspanne: Up to 12 months
|
The length of time from start of treatment to death by any cause. |
Up to 12 months
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nelli Bejanyan, MD, Moffitt Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
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
- MCC-20305
- 9BC08 (Ander subsidie-/financieringsnummer: Florida Department of Health)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .