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.

Prospective, open-label, multicentre clinical trial, phase I/IIa, to investigate the safety and tolerability of allogeneic B-cell concentrates CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses for immune response enhancement, measured as response to a preponed single vaccination - B-cell therapy trial

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003033-42-DE

Enrollment

Registered

2013-02-26

Start date

2013-09-12

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

Status post allogeneic stem cell transplantation MedDRA version: 19.0 Level: LLT Classification code 10067862 Term: Allogeneic stem cell transplantation System Organ Class: 100000004865

Interventions

Product Name: Allogeneic B-cell concentrate CD3+-depleted, CD19+-enriched, cryopreserved Pharmaceutical Form: Suspension for injection INN or Proposed INN: Allogeneic B-lymphocytes Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the safety and tolerability of escalating doses of the study medication in patients after allogeneic stem cell transplantation (donor-identical);Secondary Objective: Assessment of the effect of the study medication on the secondary immune response to a preponed single vaccination with a combined vaccine against DTPa-IPV-Hib and Prevenar 13 Detection of indications for the efficacy of the study medication;Primary end point(s): ? Difference in number, duiration and severity of AEs, ARs, SAEs, SARs and SUSARs between dose groups. ? Difference in number, duration and severity of AESIs between dose groups. ? Change in number of EBV DNA copies/ml plasma). ? Frequency of >50,000 EBV DNA copies/ml plasma). ? Occurrence of signs of a post-transplant lymphoproliferative disorder (PTLD).;Timepoint(s) of evaluation of this end point: ? Difference in number, duiration and severity of AEs, ARs, SAEs, SARs and SUSARs: before and after administration of study medication. ? Difference in number, duration and severity of AESIs: after administration of study medication. ? Change in number of EBV DNA copies/ml plasma: before and after administration of study medication. ? Frequency of >50,000 EBV DNA copies/ml plasma after administration of study medication. ? Occurrence of signs of a post-transplant lymphoproliferative disorder (PTLD): after administration of study medication.	—

Measure

Time frame

Main Objective: To investigate the safety and tolerability of escalating doses of the study medication in patients after allogeneic stem cell transplantation (donor-identical);Secondary Objective: Assessment of the effect of the study medication on the secondary immune response to a preponed single vaccination with a combined vaccine against DTPa-IPV-Hib and Prevenar 13 Detection of indications for the efficacy of the study medication;Primary end point(s): ? Difference in number, duiration and severity of AEs, ARs, SAEs, SARs and SUSARs between dose groups. ? Difference in number, duration and severity of AESIs between dose groups. ? Change in number of EBV DNA copies/ml plasma). ? Frequency of >50,000 EBV DNA copies/ml plasma). ? Occurrence of signs of a post-transplant lymphoproliferative disorder (PTLD).;Timepoint(s) of evaluation of this end point: ? Difference in number, duiration and severity of AEs, ARs, SAEs, SARs and SUSARs: before and after administration of study medication. ? Difference in number, duration and severity of AESIs: after administration of study medication. ? Change in number of EBV DNA copies/ml plasma: before and after administration of study medication. ? Frequency of >50,000 EBV DNA copies/ml plasma after administration of study medication. ? Occurrence of signs of a post-transplant lymphoproliferative disorder (PTLD): after administration of study medication.

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Secondary

Measure	Time frame
Secondary end point(s): ? Difference in mean change in the frequency of antibody-producing cells between dose groups. ? Difference in change of mean absolute number of b-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes between dose groups. ? Difference in mean change of antigen-specific antibody concentration in serum/plasma between dose groups ? Differnce in mean change of CMV DNA copies/ml plasma between dose groups. ? Differenz in number of patients with >5,000 CMV DNA copies/ml plasma or with signs of organ infestation by CMV between dose groups.;Timepoint(s) of evaluation of this end point: ? Difference in mean change in the frequency of antibody-producing cells: before and after preponed single vaccination. ? Difference in change of mean absolute number of b-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes: before and after administration of study medication. ? Difference in mean change of antigen-specific antibody concentration in serum/plasma: before and after administration of study medication. ? Difference in mean change of CMV DNA copies/ml plasma): before and after administration of study medication. ? Differenz in number of patients with >5,000 CMV DNA copies/ml plasma) or with signs of organ infestation by CMV: after administration of study medication.	—

Measure

Time frame

Secondary end point(s): ? Difference in mean change in the frequency of antibody-producing cells between dose groups. ? Difference in change of mean absolute number of b-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes between dose groups. ? Difference in mean change of antigen-specific antibody concentration in serum/plasma between dose groups ? Differnce in mean change of CMV DNA copies/ml plasma between dose groups. ? Differenz in number of patients with >5,000 CMV DNA copies/ml plasma or with signs of organ infestation by CMV between dose groups.;Timepoint(s) of evaluation of this end point: ? Difference in mean change in the frequency of antibody-producing cells: before and after preponed single vaccination. ? Difference in change of mean absolute number of b-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes: before and after administration of study medication. ? Difference in mean change of antigen-specific antibody concentration in serum/plasma: before and after administration of study medication. ? Difference in mean change of CMV DNA copies/ml plasma): before and after administration of study medication. ? Differenz in number of patients with >5,000 CMV DNA copies/ml plasma) or with signs of organ infestation by CMV: after administration of study medication.

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Countries

Germany

Contacts

Public ContactMedizinische Klinik 5

Universitätsklinikum Erlangen

julia.winkler@uk-erlangen.de+4991318543112

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 8, 2026