Trials Sponsors Conditions Drugs Pricing

Conditions

Idiopathic inflammatory myositis Systemic Lupus Erythematosus Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

Incidence of any GvHD, any grade ≥ 3 CRS or grade ≥ 3 ICANS, any grade ≥ 3 organ toxicity that does not resolve to grade ≤ 2 within 72 hours, any grade ≥ 3 immune effector cell-associated hemophagocytosis, grade ≥ 2 ICANS and CRS that does not resolve to grade 1 within 7 days following adequate therapy.

Interventions

ALDESLEUKINType not reported

CNTY-101Type not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
ALDESLEUKIN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

ALDESLEUKIN
Named ingredient: aldesleukin
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Fulfilling the 2019 ACR/EULAR classification criteria of SLE
Positivity of anti-dsDNA (>4U/L), anti-histone (+ or more), anti-nucleosome (+ or more) or anti-Sm antibodies (+ or more) at screening or documented medical history

Sponsors & Collaborators

Universitaetsklinikum Erlangen AöR
Type not reportedlead

Study Sites (1)

Universitaetsklinikum Erlangen AöR

Erlangen, 91054, Germany

Georg Schett+4991318533418 georg.schett@uk-erlangen.de

Central Study Contacts

Klinik für Rheumatologie und Immunologie

+4991318539131 Sponsor.M3@uk-erlangen.de

Study Design

Study Type: interventional
Phase: phase 1 2

Study Record Dates

First Submitted

January 31, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-519532-16-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 06:01:58 UTC

Documents

K1_Recruitment_IC_procedure

You may not qualify if:

Uncontrolled severe concomitant disease, such as cancer (except basal or squamous cell skin cancer), diabetes mellitus or severe hepatic insufficiency defined as Child Pugh score ≥ 10 (C) or unstable coronary artery disease
Severely impaired renal (GFR ≤30 ml/min/1.73m2), liver (AST/ALT >3xN, Child Pugh C), heart (NYHA IV, EF <40 %) and pulmonary (FV and DLCO <30 %) function
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Prior treatment with anti-CD19 CAR-T cell therapy
History of allogeneic bone marrow/hematopoietic stem cell transplantation
Any concomitant severe active infection, e.g., HIV, hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test; if presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrollment
Pregnant or lactating females as well as the intention to conceive during the study
Known hypersensitivity to any drug components
Malignancy in the last 5 years before screening, except localized basal cell or squamous skin carcinoma, treated curatively and without evidence of recurrence. In situ carcinoma of the cervix or breast within the past 3 years is also allowed if treated curatively and without evidence of recurrence
Requirement for immunization with live vaccine during the study period or within 14 days preceding LDC
Subjects who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent
Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
Subjects who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members)

A phase I/II study of CAR-expressing Allogenic iPSC derived NK cells for treatment of autoiMmune disease by B cELl depletion - CARAMEL

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations