A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies

Trial Title: A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies

NCT ID: NCT05932173

Condition: B-Cell Leukemia
B-Cell Lymphoma
B-cell Tumors

Conditions: Official terms:
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell

Conditions: Keywords:
B Cell
CAR-T
CD19
Leukemia
Lymphoma

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Patients will receive one of the three doses of 0.5-2*10^6/kg, 3-4*10^6/kg, 5-6*10^6/kg.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Anti-CD19 Autologous CAR-T Cell Infusion
Description: Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform
Arm group label: OlyCAR-019 Cell Infusion

Other name: OlyCAR-019

Summary: It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies.

Detailed description: OlyCAR is a novel CAR-T manufacturing system which allows to generate clinical-use CAR-T cells in short time. This study is going to evaluate the feasibility of CAR-T manufactured by OlyCAR platform in the treatment of B-Cell malignancies. The OlyCAR-019 cells will be infused by vein. Subjects will be followed for safety and efficacy up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.

Criteria for eligibility:
Criteria:
Key Inclusion Criteria: 1. A definite diagnosis of relapsed/refractory B-cell malignancies; 2. Male or female, aged 2-75 years; 3. Confirmed detectable disease； 4. Expected survival time >12 weeks; 5. Eastern cooperative oncology group (ECOG) score is 0-2; 6. Adequate liver , kidney and cardiopulmonary function; 7. Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up; 8. Willingness to complete the informed consent process and to comply with study procedures and visit schedule. Key Exclusion Criteria: 1. Presence of other concurrent active malignancy; People with severe mental disorders; 2. History of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome; 3. Acute GVHD of grade II-IV or extensive chronic GVHD; 4. Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment; 5. The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters; 6. Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections; Patients with severe history of allergy or allergic constitution; 7. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years; Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis); 8. Had undergone other clinical trials in the 4 weeks prior to participating in this trial; 9. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; 10. For patients contraindicated with cyclophosphamide and fludarabine chemotherapy; 11. Subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after UCAR-T cell reinfusion, except for adverse events; 12. Receiving donor lymphocyte infusion within 6 weeks before enrollment; 13. Pregnant and lactating women; 14. Subjects with any other condition which the investigator considers unsuitable for inclusion in the study.

Gender: All

Minimum age: 2 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Address:
City: Kunming
Zip: 650100
Country: China

Status: Recruiting

Contact:
Last name: Lihua Zhang

Phone: 64774204

Phone ext: +0871
Email: zhanglihua95@126.com

Investigator:
Last name: Sanbin Wang, MD
Email: Principal Investigator

Start date: July 1, 2023

Completion date: June 30, 2025

Lead sponsor:
Agency: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Agency class: Other

Source: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05932173