Clinical trial • Phase I|Phase III • Immunology
CD19 CAR T cells (autologous) for Chronic graft-versus-host disease
Phase I|Phase III trial of CD19 CAR T cells (autologous) for Chronic graft-versus-host disease. None/Not specified-controlled. 14 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Chronic graft-versus-host disease
- Trial Stage
- Phase I|Phase III
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 19-12-2025
- First CTIS Authorization Date
- 27-03-2026
Trial design
None/Not specified-controlled Phase I|Phase III trial across 6 sites in Germany.
- Comparator
- None/Not specified
- Target Sample Size
- 14
Eligibility
Recruits 14 Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent, assent, or special protections are provided in the available record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent, assent, or special protections are provided in the available record.
Recruitment
- Planned Sample Size
- 14
- Recruitment Window Months
- 36
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 14
Germany
- Earliest CTIS Part Ii Submission Date
- 09-03-2026
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 18
- Number Of Sites
- 6
- Number Of Participants
- 14
Sites
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Innere Medizin II
- Contact Person Name
- Daniel Teschner
- Contact Person Email
- teschner_d@ukw.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Medizinische Klinik 5
- Contact Person Name
- Silvia Spörl
- Contact Person Email
- silvia.spoerl@uk-erlangen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie
- Contact Person Name
- Antonia Busse
- Contact Person Email
- antonia.busse@charite.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Innere Medizin III
- Contact Person Name
- Daniel Wolff
- Contact Person Email
- daniel.wolff@ukr.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- II. Medizinische Klinik
- Contact Person Name
- Christoph Schmidt
- Contact Person Email
- christoph.schmid@uk-augsburg.de
- Site Name
- Universitaetsklinikum Koeln AöR
- Department Name
- Innere Medizin 1
- Contact Person Name
- Udo Holtick
- Contact Person Email
- udo.holtick@uk-koeln.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Erlangen AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Autologous CD19 CAR T cells
- Active Substance
- CD19 CAR T cells (autologous)
- Modality
- Cell therapy
- Authorisation Status
- Investigational
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