Donation of enriched donor T-cells after stem cell transplantation, which are specificly directed against multiple target structures and which confer protection against viral infections and anti-leukemic activity against leukemia cells.

Transfer of Streptamer-selected multi-antigen specific T cells to prevent infections and relapse and to reduce the risk of Graft-versus-Host Disease after allogeneic stem cell transplantation - Multi-antigen specific T Cells after allo-SCT

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003171-39-DE

Enrollment

Registered

2014-10-17

Start date

2016-03-08

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with hematological malignancies after T cell depleted allo-SCT MedDRA version: 18.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10000846 Term: Acute lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Class

Interventions

Product Name: Streptamer-selected multi-antigen specific T cells Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female patients with planned T-cell depleted allo-SCT aged >= 18 with AML in first CR Male or female patients with planned T-cell depleted allo-SCT aged >60 years or pa-tients 18-60 years with comorbidity score (Sorror) >3 with one of these diagnoses: - Acute Lymphoblastic Leukemia in CR after prephase and first induction and consolidation therapy and WBC 20 *109/L, granulocytes > 0.5 *109/L) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: Exclusion Criteria before allo-SCT: Disease specific treatment foreseen in the first 6 months after SCT Pregnant or lactating women. Severe psychological disturbances. Life expectation grade I for which immune suppressive treatment is given Progressive disease for which therapy is needed Use of > 20 mg prednisone a day Life expectation grade I for which immune suppressive treatment is given Progressive disease for which therapy is needed Use of > 20 mg prednisone a day Life expectation < 12 weeks. End stage irreversible multi-system organ failure Uncontrolled bacterial or fungal infection. Evidence of rejection.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To determine the appearance or expansion of antigen specific donor derived T cells during eight weeks after the infusion of donor derived multiantigen-specific T cells. To evaluate whether the appearance or expansion of antigen specific donor derived T cells coincides with the clearance or prevention of circulating viruses (EBV, CMV, Adenovirus) or with an improvement in bone marrow chimerism or with a control in disease burden (malignant cells in blood or bone marrow or tumor size in case of malignant lymphoma) ;Primary end point(s): Toxicity: Cumulative incidence of acute GVHD overall grade 3 or higher in the three months after infusion of multi antigen-specific T cells. Feasibility: The proportion of donors who are asked between 4 and 6 weeks after the allo-SCT to donate lymphocytes and in whom the harvesting of those cells succeeds. The proportion of procedures to isolate the multiantigen-specific donor T cells which succeeds. ;Timepoint(s) of evaluation of this end point: Toxicity of the infusion will be evaluated by the cumulative incidence of acute GVHD > overall grade II or death during three months after the infusion of the T cell product after LSLV As for feasibility, if out of the first fifteen donors who gave informed consent before allo-SCT and were asked for lymphocytes between 6 and 8 weeks, the collection of donor lymphocytes succeeds in < 6 patients, the strategy in which donor lymphocytes are collected between 6 and 8 weeks after allo-SCT is considered to be not feasible. If out of the first fifteen procedures to isolate multiantigen-specific T cells from donor lymphocytes, less than 6 result in an appropriate T cell product which can be given to the patient, the procedure is considered to be not feasible as well.;Main Objective: To assess the feasibility and safety of the administration of donor derived multiantigen-specific T cells early after T cell depleted allo-SCT	—

Measure

Time frame

Secondary Objective: To determine the appearance or expansion of antigen specific donor derived T cells during eight weeks after the infusion of donor derived multiantigen-specific T cells. To evaluate whether the appearance or expansion of antigen specific donor derived T cells coincides with the clearance or prevention of circulating viruses (EBV, CMV, Adenovirus) or with an improvement in bone marrow chimerism or with a control in disease burden (malignant cells in blood or bone marrow or tumor size in case of malignant lymphoma) ;Primary end point(s): Toxicity: Cumulative incidence of acute GVHD overall grade 3 or higher in the three months after infusion of multi antigen-specific T cells. Feasibility: The proportion of donors who are asked between 4 and 6 weeks after the allo-SCT to donate lymphocytes and in whom the harvesting of those cells succeeds. The proportion of procedures to isolate the multiantigen-specific donor T cells which succeeds. ;Timepoint(s) of evaluation of this end point: Toxicity of the infusion will be evaluated by the cumulative incidence of acute GVHD > overall grade II or death during three months after the infusion of the T cell product after LSLV As for feasibility, if out of the first fifteen donors who gave informed consent before allo-SCT and were asked for lymphocytes between 6 and 8 weeks, the collection of donor lymphocytes succeeds in < 6 patients, the strategy in which donor lymphocytes are collected between 6 and 8 weeks after allo-SCT is considered to be not feasible. If out of the first fifteen procedures to isolate multiantigen-specific T cells from donor lymphocytes, less than 6 result in an appropriate T cell product which can be given to the patient, the procedure is considered to be not feasible as well.;Main Objective: To assess the feasibility and safety of the administration of donor derived multiantigen-specific T cells early after T cell depleted allo-SCT

—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy: The appearance or doubling of antigenic specific donor-derived T cells in the circulation within eight weeks after the infusion of multiantigen-specific T cells. Chimerism in bone marrow and peripheral lymphocytes Loads of circulating viruses (CMV, EBV, Adenovirus) Disease activity: malignant cells in bone marrow or blood, size of lymphoma Death ;Timepoint(s) of evaluation of this end point: WIll be analyzed at the end of the trial after LSLV	—

Measure

Time frame

Secondary end point(s): Efficacy: The appearance or doubling of antigenic specific donor-derived T cells in the circulation within eight weeks after the infusion of multiantigen-specific T cells. Chimerism in bone marrow and peripheral lymphocytes Loads of circulating viruses (CMV, EBV, Adenovirus) Disease activity: malignant cells in bone marrow or blood, size of lymphoma Death ;Timepoint(s) of evaluation of this end point: WIll be analyzed at the end of the trial after LSLV

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Countries

Germany

Contacts

Public ContactHematology/Oncology

University Hospital Wuerzburg - Department of Medicine II

004909312 01 4 00 01

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026