Health TrialsbyHealthPanel

A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NEUK203-215 Injection in Adult Chinese Patients With Relapsed/Refractory Autoimmune Diseases

ConditionAutoimmune
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeukio Biotherapeutics (Shanghai) Co., Ltd.

About this trial

The purpose of this study is to determine the safety, tolerability and preliminary efficacy of NEUK203-215 , a healthy donor (HD) allogeneic CD19/BCMA-targeted CAR-NK cell product, in participants with severe, refractory autoimmune diseases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Has provided signed informed consent; 2) Is aged 18-65 years ; 3)Adequate functional reserve of vital organs 4) Has a confirmed diagnosis of systemic lupus erythematosus, diffuse systemic sclerosis, inflammatory myopathy, or autoimmune bullous dermatosis.

Disqualifiers

1) Requires dialysis treatment. 2) History of severe drug hypersensitivity. 3) Active infection requiring systemic therapy or suspected uncontrolled infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fludarabine

    Drug

    Specified dose on specified days

  • Cyclophosphamide (C)

    Drug

    Specified dose on specified days

  • NEUK203-215 Injection

    Genetic

    Specified dose on specified days

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse events

Time frame
Up to 12 months post NEUK203-215 infusion
2

Existence/non existence of dose limiting toxicity (DLT)

Time frame
Up to 12 months post NEUK203-215 infusion
3

serious adverse events (SAEs)

Time frame
Up to 12 months post NEUK203-215 infusion

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neukio Biotherapeutics (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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