Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06361745
Other study ID # PG-005-6
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2, 2024
Est. completion date March 1, 2025

Study information

Verified date April 2024
Source PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Contact songlou yin, master
Phone 0516-85806210
Email yinsonglou@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). Secondary purpose: To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID. To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID. To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects. To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects.


Description:

This clinical trial was designed as a single-arm, open-label, single-center, investigator-initiated early-stage clinical study to evaluate the safety of UTAA09 injection in patients with relapsed/refractory AID. After signing the informed consent letter, qualified subjects were screened for infusion of UTAA09 injection, and their blood was collected before and after infusion for pharmacokinetics, pharmacodynamics, immunogenicity, safety and other evaluation. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of 14d, 28d, 2m, 4m, 6m, 8m, 10m, 12m, 15m, 18m, 21m, 24m after cell transfusion until disease progression (PD), new anti-disease therapy, death, intolerable toxicity, investigator decision, or subject's voluntary withdrawal. Whichever comes first.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date March 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility inclusion criteria (2) Expected survival time =3 months; (3) Subjects with recurrent/refractory autoimmune diseases who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc. (3) Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction. (4) Liver and kidney function, cardiopulmonary function meet the following requirements: - Creatinine =1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands; - Blood oxygen saturation >91% in non-oxygen state; - Total bilirubin =2×ULN; ALT and AST=2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to =3.0×ULN and the direct bilirubin =1.5×ULN. (5) no serious mental disorders; (6) Can understand this test and have signed the informed consent. Exclusion criteria: 1. Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated 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; 2. Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive; 3. Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification =III), and severe arrhythmia; 4. Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment; 5. Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration; 6. Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion; 7. Patients who received CAR-T therapy or other gene-modified cell therapy before screening; 8. Participated in other clinical studies 1 month before screening; 9. Evidence of central nervous system invasion during subject screening; 10. Mental patients with depression or suicidal thoughts; 11. Those who received live vaccine within 28 days prior to screening; 12. Situations considered unsuitable for inclusion by other researchers.

Study Design


Intervention

Biological:
T cell injection targeting CD19 chimeric antigen receptor
Intravenous administration, 1 bag each time (depending on individual differences), dose: 1×108-1×109 CD19-CAR-gdT (UTAA09 injection), the investigator can decide whether to reduce or increase the dose and whether multiple infusions are required according to the condition of the subject.

Locations

Country Name City State
China PersonGen.Anke Cellular Therapeutice Co., Ltd Hefei

Sponsors (1)

Lead Sponsor Collaborator
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary AE Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities according to the Common Adverse Event Evaluation Standard NCI CTCAE version 5.0 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
Secondary Cmax The maximum amplified concentration (Cmax) of UTAA09 injection in peripheral blood after administration, the time to reach the maximum concentration (Tmax), and the area under the curve AUC0-28d at 28 days and the area under the curve AUC0-90d at 90 days 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
Secondary CD19-positive cells The content of CD19-positive cells in peripheral blood after UTAA09 injection administration: the proportion and absolute value of CD19-positive cells in peripheral blood at each time point; Concentration levels of CAR-T-associated serum cytokines. 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
Secondary Disease remission/response/improvement rates Disease remission/response/improvement rates at 28 days, 2 months, and 3 months after administration. 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
Secondary anti-CAR antibody The positive rate of human anti-CAR antibody at each time point. 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
See also
  Status Clinical Trial Phase
Terminated NCT03843125 - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) Phase 3
Recruiting NCT05698173 - Systemic Lupus Erythematosus and Accelerated Aging N/A
Active, not recruiting NCT01649765 - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy Phase 2
Recruiting NCT05704153 - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A) N/A
Completed NCT05048238 - Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus Phase 1
Recruiting NCT06056778 - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed NCT04358302 - Individual Patient Exposure and Response in Pediatric Lupus N/A
Completed NCT03802578 - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients N/A
Completed NCT02554019 - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus Phase 2
Recruiting NCT04835883 - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients Phase 2
Terminated NCT02665364 - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus Phase 2
Completed NCT00278538 - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus Phase 2
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed NCT03252587 - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus Phase 2
Terminated NCT02066311 - Nelfinavir in Systemic Lupus Erythematosus Phase 2
Recruiting NCT01892748 - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus. N/A
Terminated NCT01689025 - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE) Phase 1
Completed NCT01475149 - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE) N/A
Unknown status NCT01712529 - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients N/A
Completed NCT00962832 - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus Phase 2