A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory POEMS Syndrome (NCT06518876) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory POEMS Syndrome
China21 participantsStarted 2024-08-31
Plain-language 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 KQ-2003 CAR T-cells for patients with Relapsed/Refractory POEMS Syndrome
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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…
What they're measuring
1
Number of patients with dose-limiting toxicity (DLT)
Timeframe: Within 28 days of receiving KQ-2003 CAR T-cells transfusion therapy
2
Adverse Event
Timeframe: Minimum 2 years after KQ-2003 CAR T-cells infusion (Day 1)
3
Maximum Tolerated Dose (MTD)
Timeframe: Within 28 days of receiving KQ-2003 CAR T-cells transfusion therapy
4
Recommended Phase 2 Dose (RP2D)
Timeframe: Through study completion, an average of 1 year