A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases

NCT06318533 | Recruiting Early Phase 1 DMC

• 1 other identifier: 2023-11-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10\^9 cells, 9×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed/refractory B-cell related autoimmune diseases.

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose Limiting Toxicity (DLTs)

  To characterize the safety of anti-CD19 CAR NK Cells for moderate to severe autoimmune diseases.

  within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion

• Treatment Emergent Adverse Events（TEAEs）

  To characterize the safety of anti-CD19 CAR NK Cells for moderate to severe autoimmune diseases

  within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion

Secondary Outcomes (2)

• Disease control rate of subjects

  4, 12, 24, and 52 weeks after infusion

• Remission rate of subjects

  4, 12, 24, and 52 weeks after infusion

Study Arms (1)

anti-CD19 CAR NK cells

EXPERIMENTAL

Drug: anti-CD19 CAR NK cells

Interventions

anti-CD19 CAR NK cells DRUG

Patients will receive Fludarabine (30mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3, followed by Anti-CD19 CAR NK cells infusion.

anti-CD19 CAR NK cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures
• Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
• Age: ≥ 18 years old and ≤ 70 years old, male or female
• Subjects with estimated survival \> 12 weeks
• Adequate organs function: Serum creatinine clearance meets relevant age/sex criteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)
• ECOG performance ≤ 2
• Left ventricular ejection fraction (LVEF) ≥ 45%
• Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment

You may not qualify if:

• Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions
• Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes
• Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections
• Subjects with grade III or IV heart failure (NYHA classification)
• History of epilepsy or other central nervous system (CNS) diseases
• History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors
• Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism
• Subjects were treated with systemic corticosteroids concomitantly within 2 weeks prior to treatment
• Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months
• Females who are pregnant, lactating, or planning a pregnancy within six months
• Subjects who have received other clinical trial treatment within 3 months
• Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome

Sponsors & Collaborators

• YANRU WANG: lead
• Rui Therapeutics Co., Ltd: collaborator

Study Sites (2)

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212001, China

RECRUITING

Jiangsu University Affiliated Hospital

Zhenjiang, Jiangsu, 212001, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Rheumatology and Immunology

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 13, 2024
• Primary Completion: March 13, 2026
• Study Completion (Estimated): March 13, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)