Clinical trial • Phase I • Immunology|Rare Disease
CLonE-specific CAR T-Cell therapy for Amyloid light-chain (AL) amyloidosis|Relapsed or refractory AL amyloidosis
Phase I trial of CLonE-specific CAR T-Cell therapy for Amyloid light-chain (AL) amyloidosis|Relapsed or refractory AL amyloidosis.
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- Amyloid light-chain (AL) amyloidosis|Relapsed or refractory AL amyloidosis
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 12-09-2025
- First CTIS Authorization Date
- 25-11-2025
Trial design
None/Not specified-controlled Phase I trial across 1 site in Germany.
- Comparator
- None/Not specified
- Target Sample Size
- 7
- Trial Duration For Participant
- 516
Eligibility
Recruits 7 Vulnerable population selected; no details on consent or assent handling available..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling available.
Recruitment
- Planned Sample Size
- 7
- Recruitment Window Months
- 16
- Consent Approach
- No consent or assent process details provided in source.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 7
Germany
- Earliest CTIS Part Ii Submission Date
- 03-11-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Department of Internal Medicine V
- Principal Investigator Name
- Stefan Schoenland
- Principal Investigator Email
- stefan.schoenland@med.uni-heidelberg.de
- Contact Person Name
- Stefan Schoenland
- Contact Person Email
- stefan.schoenland@med.uni-heidelberg.de
- Number Of Participants
- 7
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Heidelberg AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- CLonE-specific CAR T-Cell therapy
- Modality
- Cell therapy
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