Treatment of chemo-refractory viral infections after allogeneicstem cell transplantation with multispecific T cells against CMV, EBV and AdV: A phase III, prospective, multicentre clinical trial
- Conditions
- MedDRA - C02stem cell transplantation
- Registration Number
- DRKS00018985
- Lead Sponsor
- Dr. von Haunersches Kinderspital Klinikum der Universität München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 149
1. Adult or paediatric patients (>2 months of age) after HSCT (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection, refractory to standard antiviral treatment for two weeks (defined as =1 log decrease in viral load over two weeks) as confirmed by quantitative blood PCR analysis
2. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection
3. Written informed consent given (patient or legal representative)
1. Acute GvHD > grade II or extensive chronic GvHD at time of IMP transfer
2. Treatment with steroids (>1 mg/kg Prednisone equivalent) at Screening
3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. In case of T-cell depleted HSCT, a prescheduled prophylactic DLI =3 x 10e5 T cells/kg BW is not considered an exclusion criteria.
4. Organ dysfunction or failure as determined by Karnofsky (age >16 years) or Lansky (age =16 years) score =30%
5. Concomitant enrolment in another clinical trial interfering with the endpoints of this study
6. Any medical condition which could compromise participation in the study according to the investigator’s assessment
7. Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study
8. Second line or experimental antiviral treatment other than Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab from Screening until 8 weeks after IMP Infusion or prohylactic Treatment other tham Aciclovir or Letermovir throughout the study except approved by sponsor
9. Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test.
10. Female patient who is pregnant or breast-feeding, or adult of reproductive potential not willing to use an effective method of birth control from Screening until the last follow-up visit (FU6, Visit 8) Note: women of childbearing potential must have a negative serum pregnancy test at study entry
11. Known hypersensitivity to iron dextran
12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Percentage of patients with viral clearance (defined as two consecutive negative PCRs)<br>- Percentage of patients with progression between Day 7 and Week 8 after T-cell transfer
- Secondary Outcome Measures
Name Time Method