Open-label clinical trial, phase I/IIa, at several study sites to investigate the safety and tolerability of selected deep-frozen immune cells from a donor in patients who underwent a stem cell transplantation, for the enhancement of the immune response, measured as response to an early vaccination. Patients receive a single dose of the study medication after day 120 following the stem cell transplantation. Increasing doses are administered to subsequent groups of patients.

Phase 1

• Conditions: Status post allogeneic stem cell transplantation; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 19.0Level: LLTClassification code 10067862Term: Allogeneic stem cell transplantationSystem Organ Class: 100000004865

• Registration Number: EUCTR2012-003033-42-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-26
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Male or female person aged 18 to 75 years.
2.Written informed consent of the patient.
3.Day 100±10 days after allogeneic stem cell transplantation.
4.Serostatus for EBV: R-/D- oder R+/D- oder R+/D+.
7.Females must in addition meet at least one of the following criteria:
menopause (minimum amenorrhoea for 12 months oder amenorrhoea for 6 Monate with serum FSH >40mU/ml) or bilateral ovarectomy or hysterectomy or vasectomy of her partner (all in medical history) or routine, correct and consequent use of a contraceptual method with a failure rate of <1%/year.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Serostatus for EBV: R-/D+.
2.Severe acute GvHD (Glucksberg grade III und IV).
3.Chronic GvHD in middle- or high-risk group according to NIH staging.
4.Rituximab administration after SCT.
5.>10.000 EBV DNA copies/ml plasma.
6.Recurrence of the haematological disorder needing therapeutic intervention.
7.Secondary transplantation.
8.SCT with transplat from a haploidentical donor.
9.SCT with transplant from umbilical cord blood.
10.CD34+-enriched transplant.
11.in vitro T-cell depleted transplant.
12.Pregnant or breast-feeding female.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified