Status:
NOT_YET_RECRUITING
A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory POEMS Syndrome
Lead Sponsor:
Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Conditions:
POEMS Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multicenter, open-label, dose-escalation/expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and determine the recommended dose of K...
Detailed Description
The study included the phase 1a dose escalation study and the phase 1b cohort extension study. The phase 1a study is an open, dose-escalation design with 3 dose groups according to the "3+3" dose esca...
Eligibility Criteria
Inclusion
- Age ≥18 years old, male or female;
- Diagnosis of POEMS syndrome with relapsed or refractory disease;
- Eastern Cooperative Oncology Group (ECOG) Performance ≤2 ;
- Adequate venous access for the apheresis of peripheral blood mononuclear cell;
- Vascular Endothelial Growth Factor (VEGF) ≥1200ng/L；
- Overall Neuropathy Limitations Scale (ONLS) ≥ 1;
- Adequate organ function;
- Able and willing to comply with the study protocol and follow-up plan, and sign the informed consent form in writing.
Exclusion
- Subjects who had previously received BCMA-CD19 dual-target CAR-T cell products or autologous stem cell transplantation within 12 weeks before the collection of peripheral blood mononuclear cells;
- Known allergy or hypersensitivity reactions to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO), CD19, or BCMA-targeted drugs;
- Received any treatment that might influence the activity of CAR-T cells prior to the collection of peripheral blood mononuclear cells;
- Have history of vaccination within the 4 weeks preceding the collection of peripheral blood mononuclear cells;
- Have tested positive for cytomegalovirus and/or mycobacterium tuberculosis, or had any uncontrolled active infection within 14 days prior to the collection of peripheral blood mononuclear cells;
- Subjects infected with active HBV or HCV, HIV, syphilis;
- Subjects with known central nervous system disease, for example, seizure disorders, clinically significant cerebral ischemia/hemorrhage, dementia);
- Subjects currently experiencing active autoimmune diseases; Diagnosed with immunodeficiency or receiving any other form of immunosuppressive therapy within 7 days prior to enrollment in this study;
- Subjects with active bleeding or VTE events (such as pulmonary embolism or deep vein thrombosis) require anticoagulation;
- Have following severe diseases: unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction , New York Heart Association (NYHA) Class ≥ III, congestive heart failure, poorly controlled severe arrhythmias or other cardiac diseases requiring mechanical support; subjects with known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal; subjects with known moderate or severe persistent asthma, or a history of asthma within the past 2 years, or currently having any category of uncontrolled asthma; subjects requiring oxygen to maintain adequate oxygen saturation; subjects with hypertension whose blood pressure cannot be lowered to the following range despite treatment with two or more antihypertensive medications;
- Have active malignancies;
- Have any non-hematologic toxicity resulting from prior treatments that cannot be restored to ≤ grade 1 or baseline, excluding alopecia and grade 2 neuropathy;
- Subjects had participated in other clinical trials and used its investigational drugs within the 3 months prior to the collection of peripheral blood mononuclear cells;
- History of alcohol abuse, drug addiction, substance abuse, or mental illness within the past year;
- Pregnant or lactating women;
- Any situation that the investigator believes may increase the risk of subjects or interfere with the results of clinical trials
Key Trial Info
Start Date :
August 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06518876
Start Date
August 31 2024
End Date
December 31 2027
Last Update
July 24 2024
Active Locations (1)
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1
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, China, 100730