An Open-label Phase I/II Safety and Feasibility Basket Study of UKT-CART19.1

November 5, 2026 updated by: University Hospital Tuebingen

An Open-label Phase I/II, Single-center, Interventional Singlearm Basket Trial of UKT-CART19.1 in Patients With Relapsed/Refractory Autoimmune Diseases

An open-label phase I/II, single-center, interventional single-arm basket trial of UKT-CART19.1 in patients with relapsed/refractory autoimmune diseases

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 727076
        • University Hospital , Department of Internal Medicine II
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ann-Christin Pecher, PD Dr. med.
        • Sub-Investigator:
          • Joerg Henes, Prof. Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients at least 18 years of age, and ≤ 80 years old at the time of signing the informed consent

  2. Signed and dated informed consent by participants before conduct of any trial-specific procedure

  3. One of the following diseases according to the EULAR/ACR criteria (see appendices) for IIM/AAV/RA/SSc; McDonald criteria Wingerchuk et al., 2015; KKNMS; Sechi et al., 2022 for MS or clinical standards for PV and ITP plus disease active according to the specific disease as follows:

    • Idiopathic inflammatory myositis (IIM): Disease activity defined by CK > 3x ULN and clinical symptoms and / or disease activity documented by MRI
    • ANCA associated vasculitis (AAV): Disease activity defined as BVAS-3 new/worse > 6, i.e. ongoing or new organ damage (lung, kidney or CNS)
    • Rheumatoid Arthritis (RA): Disease activity defined DAS28 > 4
    • Pemphigus vulgaris (PV): Disease activity defined by PDAI >15 points
    • Multiple sclerosis (MS): clinical activity previous 24 months: greater than or equal to 1 relapse with or without increase of EDSS, clinical progression previous 24 months: increase of EDSS 1 or increase in other MS-related measures (such as 25FWT, 9HPT, SDMT), MRI activity previous 24 months: greater than or equal to 1 Gd+ lesion or new or new enlarging T2-hyperintense lesion greater than or equal to 3 mm, failure of greater than or equal to 2 high efficacy therapy (not included in AHCST criteria)
    • Immune thrombocytopenic purpura (ITP): Disease activity defined as thrombocytes <30.000/µl and/or <50.000/µl and signs of bleeding
    • Systemic scleriosis (SSc): Disease activity defined as a worsening of mRSS > 25% and/or decline of FVC >10% and/or decline of DLCO >15% (of predicted values) and/or new organ involvement (heart, kidney)

    AND refractory to at least (but not limited) to 2 immunosuppressive disease-specific standard treatment:

    • IIM: greater than or equal to 2 standard treatments in accordance with the current AWMF S2k Guideline (S2kLeitlinie Myositissyndrome. Version: 6.0 Stand: 28.04.2022 Gültig bis: 27.04.2027)
    • AAV: greater than or equal to 2 standard treatments in accordance with EULAR recommendations (Hellmich B et al. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update. Ann Rheum Dis. 2024 Jan 2;83(1):30-47. doi: 10.1136/ard-2022-223764. PMID: 36927642.
    • RA: greater than or equal to 4 standard treatments in accordance with the current EULAR Recommendations for the Management of RA (Smolen J et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biologic disease-modifying antirheumatic drugs: 2025 update Annals of the Rheumatic Diseases, 2026; 85, 991-1009)
    • PV: greater than or equal to 2 standard treatments in accordance with the current S2k Guideline (S2k-Leitlinie Diagnostik und Therapie des Pemphigus vulgaris / foliaceus und des bullösen Pemphigoids. Version: 3.0 Stand: 01.04.2026 Gültig bis: 31.03.2031).
    • MS: greater than or equal to 2 high efficacy therapy ("Wirksamkeitskategorie 3") in accordance with the current S2k Guideline (Hemmer B. et al., Diagnose und Therapie der Multiplen Sklerose, Neuromyelitis-optica-Spektrum-Erkrankung (NMOSD) und MOG-IgG-assoziierten Erkrankung (MOGAD), S2k-Leitlinie, 2026, in: Deutsche Gesellschaft für Neurologie (Hrsg.), Leitlinien für Diagnostik und Therapie in der Neurologie. Online: www.dgn.org/leitlinien (abgerufen am 15.06.2026)
    • ITP: failure of at least Glucocorticoids, Thrombopoetin receptor agonists (TPO-RA) and Fostamatinib in accordance with the current Onkopedia Guideline (DGHO Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e. V. (Hrsg.): Immunthrombozytopenie (ITP). Onkopedia Leitlinie. Stand: August 2024. https://www.onkopedia.com/de/onkopedia/guidelines/immunthrombozytopenie-itp (Abgerufen am: 15.06.2026))
    • SSc: greater than or equal to 2 standard of care systemic treatment in accordance with the current EULAR Recommendations ( Del Galdo F et alEULAR recommendations for the treatment of systemic sclerosis: 2023 update Annals of the Rheumatic Diseases Published Online First: 11 October 2024. doi: 10.1136/ard-2024-226430)

  4. Male participants able to father children and female participants of childbearing potential must practice true abstinence or agree to use 2 highly effective methods (i.e. those that result in a low failure rate (i.e., < 1% per year) of contraception throughout the duration of the study. Male fertile subjects must also not donate sperm during the study and for at least 12 months following the UKT-CART19.1 infusion

  5. Female Subject of childbearing potential and male subjects with female partner of childbearing potential is willing to use highly effective contraceptive methods during treatment until 12 months after IMP exposure.

    For the purpose of this document, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm apostmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. For the purpose of this document, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Highly effective methods are defined as those that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly. The following are highly effective methods of contraception:

    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1: - oral - intravaginal - transdermal

    • progestogen-only hormonal contraception associated with inhibition of ovulation1:

    • oral

    • injectable

    • implantable2

    • intrauterine device (IUD) 2

    • intrauterine hormone-releasing system (IUS)2

    • bilateral tubal occlusion2

    • vasectomised partner2,3

    • sexual abstinence4

      1. Hormonal contraception may be susceptible to interaction with the IMP, which may reduce the efficacy of the contraception method.
      2. Contraception methods that in the context of this guidance are considered to have low user dependency.
      3. Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success.
      4. In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Woman of childbearing potential (WOCBP) must also: - Have a negative pregnancy test as verified by the Investigator, one negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test result at screening, prior to LD. This applies even if the subject practices true abstinence from heterosexual contact. - Perform pregnancy testing every month for 6 months after IMP administration. A home test is sufficient.

    • Agree to abstain from breastfeeding during study participation and for at least 12 months after IMP administration.

  6. All subjects must agree to refrain from donating blood while on study drug and for 1 year after discontinuation from this study treatment.

  7. Absolute CD3+ T cell count ≥100/μl at time of leukapheresis

  8. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

  9. Subject must have recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy

  10. Subject must have adequate vascular access for leukapheresis

  11. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted

  12. Subject is willing and able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials

Exclusion Criteria:

  1. Subject used any investigational agents within 15 days of leukapheresis

  2. Contraindications to the IMP and its components, including but not limited to hypersensitivity to the CAR-T cell product, excipients, lymphodepleting agents and/or tocilizumab.

  3. Subject received any of the following within the last 7 days of leukapheresis:

    Major surgery (as defined by the investigator) Radiation therapy Use of any systemic anti-neoplastic drug therapy

  4. Patients who have previously received gene therapy

  5. History or presence of clinically relevant CNS pathology other than the underlying diseases in this protocol, such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.

  6. Subject has any of the following laboratory abnormalities:

    Absolute lymphocyte count <100/µL at time of leukapheresis Serum Creatinine Clearance (CrCl) < 30 mL/min Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN), non-Myositis related Serum total bilirubin > 3.0 mg/dL for subjects with documented Gilbert's syndrome

  7. Echocardiography (ECHO) or MRI with left ventricular ejection fraction < 40%

  8. Subject with a history of Class III or IV congestive heart failure (CHF)

  9. Subject with a history of myocardial infarction within the last 12 months

  10. Patients unable to stop immunosuppressive treatment prior to leukapheresis (AZA, TAC, MMF, CYC, mitoxantrone, JAK inhibitors, or GC at prednisolone equivalent dose >10mg/day). Intermittent topical, inhaled or intranasal corticosteroids are allowed

  11. Subject is positive for human immunodeficiency virus (HIV-1), uncontrolled hepatitis B or C

  12. Subject with FVC <45%, and/or DLCO (corrected for Hb) <30%

  13. Subjects with pulmonary comorbidities (including but not limited to active smoking habits, oxygen requirements, and severe asthma)

  14. Subject has uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment

  15. Subject with prior history of malignancies, unless the subject has been free of the disease for ≥ 1year with the exception of the following non-invasive malignancies:

    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative

  16. Subject is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during participation in the study

  17. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

  18. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Safety and feasibility

Open-label, single centre, non-randomized, non-comparative, Phase I/II basket study of safety and feasibility
Biological: CAR-T cells targeting CD19

Single dose containing 1.0×10^6CAR+ cells per kg body weight

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of UKT-CART19.1 in refractory and/or relapsed autoimmune diseases
Time Frame: 6 months

Safety of UKT-CART19.1 in refractory and/or relapsed autoimmune diseases at month 6 by

  • number of serious adverse events (SAE)
  • number of AE of special interests (AESI) in the first 28 days after CAR T cell infusion, classified according to CTCAE version 6.0
  • non-relapse mortality (NRM) on day 28 and acute infusional toxicity after infusion of the IMP. AESI following the first 28 days after CAR T cell infusion are defined as described in chapter 7 and 9
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Tuebingen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann-Christin Pecher, University Hospital , Department of Internal Medicine II

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UKT-CART19.1 in r/r AID
  • 2024-519491-60-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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