Actively Recruiting
An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia
Led by Changzhou No.2 People's Hospital · Updated on 2025-04-30
9
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
C
Changzhou No.2 People's Hospital
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells (KN5501) in patients with refractory immune thrombocytopenia. 9 patients are planned to be enrolled in the dose-escalation trial (9×10\^9 cells, 13.5×10\^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 evaluation of KN5501 for the treatment of refractory immune thrombocytopenia. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with refractory immune thrombocytopenia.
CONDITIONS
Official Title
An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, male or female, willing to participate and sign informed consent
- Diagnosed with immune thrombocytopenia (ITP) per American Society of Hematology 2019 guidelines and International ITP Working Group
- Platelet count decreased in at least two consecutive routine blood tests with normal blood cell morphology
- Spleen is not enlarged at screening
- Bone marrow cells show increased or normal megakaryocytes with impaired maturation
- No secondary thrombocytopenia from autoimmune diseases, thyroid disorders, blood disorders, infections, drug-induced causes, pregnancy, congenital causes, or other excluded conditions
- Refractory ITP not responding to first-line therapies, thrombopoietic agents, rituximab, or unsuccessful splenectomy
- ECOG performance status score of 1 or lower
- Left ventricular ejection fraction (LVEF) of 50% or higher with no significant pericardial effusion
- At least 4 weeks since last treatment with radiotherapy, chemotherapy, monoclonal antibodies, or other therapies
- Stable on specific antimalarial or immunosuppressive treatments as allowed
You will not qualify if you...
- Known severe allergies or hypersensitivity to cyclophosphamide, fludarabine, tozumabs, or other trial medications
- Active infection needing intravenous antibiotics or recent IV antibiotic treatment within 1 week before infusion
- Acquired or congenital immunodeficiency diseases
- Severe heart failure (NYHA class III or IV)
- History of epilepsy or other central nervous system diseases
- History of severe herpes infections such as herpes encephalitis or ocular herpes
- History of primary malignant tumors except certain cured cancers like non-melanoma skin cancer or cervical, bladder, breast cancer
- Signs of herpes or varicella zoster infection within 12 weeks before screening
- Significant medical conditions affecting heart, endocrine, blood, liver, immune system, metabolism, kidney, lung, nervous system, skin, psychiatric health, or other diseases preventing treatment
- Females who are pregnant, breastfeeding, or planning pregnancy within 6 months
- History or current diagnosis of non-ITP thrombocytopenia
- Participation in other clinical trials within past 3 months
- Any condition that increases risk or interferes with study as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Changzhou Second People's Hospital
Changzhou, Jiangsu, China, 213000
Actively Recruiting
Research Team
X
Xuzhang Lu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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