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A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)

ConditionSystemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangdong Ruishun Biotech Co., Ltd

About this trial

This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign an ICF and expect to complete the subsequent follow-up.

Age 18～65 years old (including cut-off value), gender is not limited.

Diagnosed with SLE according to the 2019 EULAR/ACR version of the revised criteria.

Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 points; Anti-nuclear antibody titer ANA≥1:80, or positive anti-dsDNA and/or anti-Sm antibodies.

Disqualifiers

Other malignancies within 5 years prior to screening, except adequately treated non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma) or carcinoma in situ of the cervix;

Major surgery requiring hospitalization within 4 weeks prior to screening or during screening;

History of severe drug allergies or anaphylactic constitution;

Renal disease: Diagnosed with active severe lupus nephritis within 8 weeks prior to screening, requiring treatment with drugs prohibited by the study protocol for the treatment of active nephritis, hemodialysis or prednisone dose ≥ 100 mg/d, or equivalent glucocorticoids for ≥14 days; Creatinine clearance rate < 60mL/min and serum creatinine > 1.5 times ULN within 1 week before lymphodepleting chemotherapy;

Trial design

Design model

Single group

Treatments tested in this trial

  • RJMty19 (CD19-CAR-DNT cells)

    Biological/Vaccine

    Lentiviral vector-transducted double negative T cells (DNT) to express anti-CD19 CAR. Prior to cellular infusion, each patient received cyclophosphamide and fludarabine lymphodepleting chemotherapy.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: RJMty19 (CD19-CAR-DNT Cells)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity (DLT)

To evaluate the safety, tolerability, and determine the recommended dosage of RJMty19 for SLE subjects

Time frame
Up to 28 days
2

Maximum Tolerated Dose (MTD)

MTD is the highest dose for DLT in ≤1/6 subjects

Time frame
Up to 28 days
3

Incidence of abnormalities

Incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs.

Time frame
Up to 28 days

Secondary outcomes

1

Pharmacokinetics (PK) indicator (Cmax)

The peak concentration of CD19-CAR-DNT cells amplified in the peripheral blood (Cmax, detected by qPCR and Flow Cytometry).

Time frame
Up to 28 days
2

Pharmacokinetics (PK) indicator (AUC)

CD19-CAR-DNT cells blood concentrations will be measured at different time points to evaluate the area under the curve (AUC). (AUC, detected by qPCR and Flow Cytometry)

Time frame
Up to 90 days
3

Pharmacokinetics (PK) indicator (CAR copy numbers)

Changes in CAR copy numbers after injection of RJMty19

Time frame
Up to 24 months
4

Remission rate of SLE based on DORIS criteria

cSLEDAI=0 and PGA \< 0.5

Time frame
at 3 months, 6 months, 12 months and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Ruishun Biotech Co., Ltd

Lead sponsor

RenJi Hospital

Collaborator

Peking University People's Hospital

Collaborator

Changhai Hospital

Collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: