Safety and Efficacy of PRG-2311 for Refractory Lupus Nephritis and IgG4-Related Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Lupus Nephritis and IgG4-Related Disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years old;
If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2;
Absolute lymphocyte count: ≥ 0.5 × 10 ^ 9/L [The use of granulocyte colony-stimulating factor (G CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination];
Absolute neutrophil count: ≥ 1.0 × 10 ^ 9/L [The use of granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination];
Disqualifiers
Pregnant or lactating women;
A history of malignant tumors within 5 years （①Carcinoma in situ of the cervix that has undergone curative treatment for more than 12 months prior to screening, ②Basal cell or squamous cell carcinoma of the skin that has been treated therapeutically, ③ Prostate cancer that has been treated with radical prostatectomy or curative radiation therapy for more than 3 years prior to screening has no known recurrence and is not currently receiving treatment；④have had surgery for thyroid cancer, and have not evidence of active disease）;
Received any B-cell depletion biologic therapy (for example, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, etc) in the 6 months prior to CAR-T reinfusion, unless B-cell recovery was demonstrated;
Received immunosuppressant therapy within 3 days prior to CAR-T reinfusion, or systemic corticosteroid therapy (>10 mg/ day of prednisone or equivalent doses of other corticosteroids) within 3 days prior to CAR-T reinfusion;
Trial design
Design model
Sequential
Treatments tested in this trial
PRG-2311
Biological/VaccinePRG-2311 (CD19/BCMA-targeting CAR-T Cells)
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: CAR T cells therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safe dose of PRG-2311 infusion
To evaluate the safe dose of PRG-2311 infusion, 3 dosage group were designed in this trial, they are 35×10\^6 CAR-T, 100×10\^6 CAR-T, and 300×10\^6 CAR-T
Time frame
Up to 24 months after PRG-2311 infusion2
Occurrence of AE after PRG-2311 infusion
To evaluate the occurrence of AE after PRG-2311 infusion based on CTCAE v5.0
Time frame
Up to 24 months after PRG-2311 infusionSecondary outcomes
1
LN: Changes of SLE disease activity Index (SLEDAI-2000) score
SLEDAI-2000 is the most commonly used SLE assessment scale. A total of 24 items, the total score is 105 points, scores ≤6 points indicates mild activity, ≥7 but ≤12 is classified as moderate activity, \>12 is classified as severe activity.
Time frame
Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion2
LN: Changes of FACIT score
FACIT score is used to assess the fatigue status of patient
Time frame
Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion3
LN: Changes of PGA score
PGA score is used to assess the disease activity status of patient by physician
Time frame
Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion4
LN: Changes of UPCR
UCPR: urinary protein creatinine ratio (ug/mg)
Time frame
Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tongji Hospital
Lead sponsor
Shenzhen Pregene Biopharma Co., Ltd.
Collaborator
Source ClinicalTrials.gov