Lupus NephritisEarly Phase 1NCT06497361
Safety and Efficacy of PRG-2311 for Refractory Lupus Nephritis and IgG4-Related Disease
A Early Phase 1 study testing PRG-2311 in people with Lupus Nephritis and IgG4-related Disease, run by Tongji Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lupus Nephritis, IgG4-related Disease
- What is being tested?
- PRG-2311
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2024to Jul 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2;
- The following test values within 3 days before the collection of mononuclear cells meet the following standards:
- 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];
- Platelets: Subject platelet count ≥ 50 × 10 ^ 9/L (subjects are not allowed to receive blood transfusion support within 7 days before the screening period laboratory examination);
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- Hemoglobin: ≥ 8.0 g/dL (allowing the use of recombinant human erythropoietin) [subjects have not received red blood cell (RBC) infusion within 7 days prior to the screening period laboratory examination];
- Creatinine clearance rate: (CrCl) or glomerular filtration rate (GFR) (Cockcroft Gault formula) ≥ 30 mL/min;
- Total bilirubin (serum): Total bilirubin (serum) ≤ 1.5 × ULN; Blood bilirubin>1.5 × Gilbert subjects from ULN can be enrolled with the consent of the sponsor AST and ALT: ≤ 3.0 × ULN;
- Plasma prothrombin time (PT), international standardized ratio (INR), partial prothrombin time (APTT): PT ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN, INR ≤ 1.5 × ULN Willing to sign an informed consent form.
- Fertile men and women of childbearing age must agree to use effective contraception from the time they sign an informed consent and up to 1 year after the study drug is used. Blood pregnancy tests for women of reproductive age at the time of screening and before cell infusion must be negative.
- The patients or their guardians agree to participate in the clinical study and sign the informed consent, indicating that they understand the purpose and procedure of the clinical study and are willing to participate in the study.
- for refractory LN
- According to the 2019 American Society of Rheumatology (ACR) criteria, diagnosed with systemic lupus erythematosus, within 6 months prior to infusion, confirmed by renal tissue biopsy according to the 2003 International Society of Nephrology (ISN)/Society of Nephropathology (RPS) criteria as active, proliferative lupus nephritis (LN), type III or IV, or type III/IV combined with type V, or type V. And have received standard treatment that is ineffective or relapses after disease remission.
- Positive anti-nuclear antibodies (ANA) and/or anti-dsDNA antibodies during the screening period.
- The SLE Disease Activity Index (SLEDAI-2000) score during the screening period is ≥ 8. SLEDAI-2000 clinical score ≥ 6 points, but low complement and/or anti ds-DNA positivity can be selected.
- for refractory IgG4-RD
- According to the 2019 ACR/EULAR criteria, diagnosed with IgG4-RD;
- The clinical manifestations were recurrent or refractory IgG4-RD;
- IgG4-RD response index (RI) ≥2, the disease is in the active stage;
- meet the clinical phenotype of Mikulitz/systemic
Who cannot join
- Subjects who meet any of the following criteria should be excluded from this study:
- 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;
- Received live vaccine or live therapeutic STDS within 2 weeks prior to screening;
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- The presence of chronic and active hepatitis B (except for HBV DNA testing below 500IU/ml), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, or syphilis infection;
- With an active infection that requires intravenous antibiotics or hospitalization;
- Obvious evidence of cardiovascular disease as follows: a N-terminal B-type natriuretic peptide (NT proBNP)>8500ng/L; b. The New York Heart Association (NYHA) classifies heart failure as Grade IV; c. Patients who received hospitalization for unstable angina or myocardial infarction within 6 months prior to the first administration, or patients who received percutaneous cardiac intervention and received the most recent stent placement within 6 months or coronary artery bypass grafting within 6 months;
- People who have a known allergy, hypersensitivity, intolerance, or contraindication to any component of PRG-2311 or the drugs that may be used in the study, including fludarabine, cyclophosphamide, tolumab, or albumin, or who have had a prior severe allergic reaction;
- Patients with other conditions determined by the investigator to be unsuitable for lymphocyte clearance or cell infusion, or who are otherwise unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Lingli Dong, MD, 02783665519, tjhdongll@163.com
Ziwei Hu, MD, 02783665518, 836048368@qq.com
About this study
Official title: Safety and Efficacy of PRG-2311 (CD19/BCMA-targeting CAR-T Cells) for Refractory Lupus Nephritis and IgG4-Related Disease
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.
- Conditions
- Lupus Nephritis, IgG4-related Disease
- Being tested
- PRG-2311
- Medical subject headings
- Lupus Nephritis, Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRG-2311Biological
PRG-2311 (CD19/BCMA-targeting CAR-T Cells)
| Study group | Role | What they receive |
|---|---|---|
| CAR T cells therapy | Experimental | The study was divided into two phases: dose exploration phase and dose extension phase. Three dose levels (35×10^6 CAR-T, 100×10^6 CAR-T, 300×10^6 CAR-T) were planned for the dose-exploration phase, and 3 to 6 LN or IgG4-RD subjects were included in each dose group. When 1 out of 3 subjects in a dose group showed DLT, 3 subjects were re-enrolled at that dose level. If DLT occurs in ≥2 of 6 subjects, dose reduction or study termination should be considered.
The safe and effective fixed dose of PRG-2311 was determined through the dose-exploration phase, and after evaluation by the investigators, the dose-expansion phase was conducted, in which an additional 3-6 subjects were included in the safe and effective fixed dose for each of the two indications (Lupus Nephritis and IgG4-Related Disease) to further determine the safety and efficacy of this dose for each indications. Receives: Biological: PRG-2311 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 months after PRG-2311 infusion
Occurrence of AE after PRG-2311 infusion
To evaluate the occurrence of AE after PRG-2311 infusion based on CTCAE v5.0
Measured: Up to 24 months after PRG-2311 infusion
Secondary outcomes (23)
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.
Measured: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: Changes of FACIT score
FACIT score is used to assess the fatigue status of patient
Measured: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: Changes of PGA score
PGA score is used to assess the disease activity status of patient by physician
Measured: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: Changes of UPCR
UCPR: urinary protein creatinine ratio (ug/mg)
Measured: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: Changes of eGFR
eGFR : estimated glomerular filtration rate (ml/min/1.73m^2)
Measured: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: overall response rate (complete or partial renal response
complete renal response rate or partial renal response rate
Measured: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
IgG4-RD: time to disease relapse
Definition:The number of days between the date of CAR-T infusion and the date of IgG4-RD recurrence determined by a clinical professional physician during the follow-up period
Measured: Up to 24 months after PRG-2311 infusion
IgG4-RD: changes in the proportion of patients with improved disease activity (IgG4-RD RI)
IgG4-RD (IgG4-RD RI) responder index is the most commonly used IgG4-RD assessment scale
Measured: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
IgG4-RD: The annual relapse rate
The annual recurrence rate
Measured: Up to 24 months after PRG-2311 infusion
IgG4-RD: The proportion of patients achieved a complete response at week 52
The proportion of complete response
Measured: 24 months after cell infusion
PK: the feature of copy numbers of CAR-Cmax
Cmax
Measured: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: the feature of copy numbers of CAR-Tmax
Tmax
Measured: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: the feature of copy numbers of CAR-AUC0-28d
Cmax、Tmax、AUC0-28d、AUC0-90d、T last of the copy numbers of CAR
Measured: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: the feature of copy numbers of CAR-AUC0-90d
AUC0-90d
Measured: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: the feature of copy numbers of CAR-T last of the copy numbers of CAR
T last of the copy numbers of CAR
Measured: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: changes of the proportion of CAR-T cells to T cells
Flow cytometry is used to detect the proportion of CAR-T cells to T cells.
Measured: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month
PD: changes of the levels of plasma sBCMA, IgG, IgA, IgM, complement C3 and C4
Immunology-related index
Measured: Screening period, Baseline, Day 14, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PD: changes of pathogenic antibody titers
Changes of ANA, anti-JO1, anti-SSA, anti-SSB, anti-Ro52, anti-centromerin B, anti-histone, anti-rRNP, anti-Scl70, anti smith, anti-ul-RNP and anti-dsDNA antibody titers in peripheral blood (only for enrolled lupus nephritis patients), and changes of IgG1, IgG2, IgG3, IgG4, and IgE (only for enrolled IgG4-RD patients)
Measured: Screening period, Baseline, Day 14, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PD: changes of immunoinflammation related laboratory indices
Changes of laboratory indices related to immune responses and inflammation in peripheral blood, including ESR, hsCRP, LDH, and serum cytokines
Measured: Screening period, Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28 after cell infusion
PD: changes of T and B lymphocyte subpopulations in peripheral blood
Changes of lymphocyte subgroup in peripheral blood
Measured: Screening period, Baseline, Day 14, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
BCMA expression levels of memory B cells and plasma blast cells
BCMA expression levels of memory B cells and plasma blast cells in peripheral blood
Measured: Screening period, baseline, Day 14, Day 28, month 2, month 3, month 6, month 9, month 12 and month 24
Single cell sequencing
Single cell sequencing of peripheral blood T cells, B cells and CAR-T
Measured: Screening period, 3 months after cell infusion (or B cell recovery stage), or depending on the investigator's assessment
The change of national planning vaccine antibody levels
To evaluate the effect of CAR-T clearance of B cell on immunological protection after vaccination
Measured: Screening period, 3 months after cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Responsible party
- Principal investigator, Lingli Dong, Tongji Hospital
- Investigators
- Lingli Dong, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497361
- Sponsor's protocol ID
- S114
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of PRG-2311 (CD19/BCMA-targeting CAR-T Cells) for Refractory Lupus Nephritis and IgG4-Related Disease
- ClinicalTrials.gov ID
- NCT06497361
- Acronym / sponsor ID
- S114
- Conditions
- Lupus Nephritis, IgG4-related Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR T cells therapy | Experimental | Biological: PRG-2311The study was divided into two phases: dose exploration phase and dose extension phase. Three dose levels (35×10^6 CAR-T, 100×10^6 CAR-T, 300×10^6 CAR-T) were planned for the dose-exploration phase, and 3 to 6 LN or IgG4-RD subjects were included in each dose group. When 1 out of 3 subjects in a dose group showed DLT, 3 subjects were re-enrolled at that dose level. If DLT occurs in ≥2 of 6 subjects, dose reduction or study termination should be considered. The safe and effective fixed dose of PRG-2311 was determined through the dose-exploration phase, and after evaluation by the investigators, the dose-expansion phase was conducted, in which an additional 3-6 subjects were included in the safe and effective fixed dose for each of the two indications (Lupus Nephritis and IgG4-Related Disease) to further determine the safety and efficacy of this dose for each indications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥ 18 years old;
- If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2;
- The following test values within 3 days before the collection of mononuclear cells meet the following standards:
- Fertile men and women of childbearing age must agree to use effective contraception from the time they sign an informed consent and up to 1 year after the study drug is used. Blood pregnancy tests for women of reproductive age at the time of screening and before cell infusion must be negative.
- The patients or their guardians agree to participate in the clinical study and sign the informed consent, indicating that they understand the purpose and procedure of the clinical study and are willing to participate in the study.
Key exclusion criteria (11 listed)
- 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;
- Received live vaccine or live therapeutic STDS within 2 weeks prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRG-2311PRG-2311 (CD19/BCMA-targeting CAR-T Cells) | Biological | CAR T cells therapy |
Primary outcome
Safe dose of PRG-2311 infusion
Time frame: Up to 24 months after 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
Occurrence of AE after PRG-2311 infusion
Time frame: Up to 24 months after PRG-2311 infusion
To evaluate the occurrence of AE after PRG-2311 infusion based on CTCAE v5.0
23 secondary outcomes
LN: Changes of SLE disease activity Index (SLEDAI-2000) score
Time frame: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: Changes of FACIT score
Time frame: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: Changes of PGA score
Time frame: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: Changes of UPCR
Time frame: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: Changes of eGFR
Time frame: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
LN: overall response rate (complete or partial renal response
Time frame: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
IgG4-RD: time to disease relapse
Time frame: Up to 24 months after PRG-2311 infusion
IgG4-RD: changes in the proportion of patients with improved disease activity (IgG4-RD RI)
Time frame: Baseline,1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
IgG4-RD: The annual relapse rate
Time frame: Up to 24 months after PRG-2311 infusion
IgG4-RD: The proportion of patients achieved a complete response at week 52
Time frame: 24 months after cell infusion
PK: the feature of copy numbers of CAR-Cmax
Time frame: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: the feature of copy numbers of CAR-Tmax
Time frame: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: the feature of copy numbers of CAR-AUC0-28d
Time frame: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: the feature of copy numbers of CAR-AUC0-90d
Time frame: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: the feature of copy numbers of CAR-T last of the copy numbers of CAR
Time frame: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PK: changes of the proportion of CAR-T cells to T cells
Time frame: Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28, 2nd month, 3rd month
PD: changes of the levels of plasma sBCMA, IgG, IgA, IgM, complement C3 and C4
Time frame: Screening period, Baseline, Day 14, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PD: changes of pathogenic antibody titers
Time frame: Screening period, Baseline, Day 14, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
PD: changes of immunoinflammation related laboratory indices
Time frame: Screening period, Baseline, Day 2, Day 6, Day 10, Day 14, Day 21, Day 28 after cell infusion
PD: changes of T and B lymphocyte subpopulations in peripheral blood
Time frame: Screening period, Baseline, Day 14, Day 28, 2nd month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month after cell infusion
BCMA expression levels of memory B cells and plasma blast cells
Time frame: Screening period, baseline, Day 14, Day 28, month 2, month 3, month 6, month 9, month 12 and month 24
Single cell sequencing
Time frame: Screening period, 3 months after cell infusion (or B cell recovery stage), or depending on the investigator's assessment
The change of national planning vaccine antibody levels
Time frame: Screening period, 3 months after cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lingli Dong principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PRG-2311 in people with Lupus Nephritis and IgG4-related Disease, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingli Dong (02783665519, tjhdongll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe dose of PRG-2311 infusion (time frame: Up to 24 months after PRG-2311 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.