Peking Union Medical College Hospital
Beijing, Beijing/China, 100000, China
NCT Number: NCT04655677
This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B-NHL patients.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Beijing, Beijing/China, 100000, China
The study will include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepleting, C-CAR039 infusion, and Follow-up Visit.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Criteria: Inclusion Criteria:
Exclusion criteria
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
Other names: C-CAR039
Time frame: Up to 24 months after C-CAR039 infusion
Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria
Time frame: Up to 24 Months after C-CAR039 infusion
Detect CAR-T copies number by qPCR
Time frame: Up to 24 Months after C-CAR039 infusion
Detect CAR-T copies number by qPCR
Time frame: Up to 24 Months after C-CAR039 infusion
Detect CAR-T copies number by qPCR
Time frame: Up to 28 days after C-CAR039 infusion
Detect CAR-T copies number by qPCR
Time frame: Up to 24 Months after C-CAR039 infusion
Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria
Time frame: Up to 24 Months after C-CAR039 infusion
The time from the date of first response (PR or better) to the date of disease progression or death after C-CAR039 infusion
Time frame: Up to 24 Months after C-CAR039 infusion
The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death
Time frame: Up to 24 Months after C-CAR039 infusion
The time from C-CAR039 infusion to the date of death
Peking Union Medical College Hospital
Other
A Phase 1 Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Subjects With Relapsed and/or Refractory NHL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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