CompletedPhase 1

A Study of C-CAR039 Treatment in Subjects With r/r NHL SubjectsNon-Hodgkin's Lymphoma

China7 participantsStarted 2020-11-27

Plain-language summary

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.

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18-70 years (include 18 and 70), male or female;
✓. Expected survival ≥ 12 weeks
✓. ECOG score 0-2
✓. CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria, including DLBCL, PMBCL, tFL, FL and MCL;
✓. Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
✓. For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded;
✓. No contraindications of apheresis.
✓. At least one measurable lesion according to Lugano 2014 criteria;

✕. Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
✕. Active HIV, HBV, HCV or treponema pallidum infection ;
✕. Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy;
✕. Any uncontrolled active disease that prevents participation in the trial
✕. Any situation that the investigator believes will harm the safety of the subjects or interfere with the purpose of the study
✕. Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after C-CAR039 infusion;
✕. Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
✕. Patients who have been previously infected with tuberculosis;

Incidence and severity of adverse events (AE)

Timeframe: Up to 24 months after C-CAR039 infusion

NCT IDNCT04696432

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-31

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18-70 years (include 18 and 70), male or female;
✓. Expected survival ≥ 12 weeks
✓. ECOG score 0-2
✓. CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria, including DLBCL, PMBCL, tFL, FL and MCL;
✓. Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
✓. For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded;
✓. No contraindications of apheresis.
✓. At least one measurable lesion according to Lugano 2014 criteria;

✕. Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
✕. Active HIV, HBV, HCV or treponema pallidum infection ;
✕. Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy;
✕. Any uncontrolled active disease that prevents participation in the trial
✕. Any situation that the investigator believes will harm the safety of the subjects or interfere with the purpose of the study
✕. Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after C-CAR039 infusion;
✕. Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
✕. Patients who have been previously infected with tuberculosis;