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

NCT ID: NCT05932173

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-06-30

Brief 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.

Conditions

B-Cell Leukemia; B-Cell Lymphoma; B-cell Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OlyCAR-019 Cell Infusion

OlyCAR-019 cell infusion will be administered by vein after short-time manufacture.

Group Type: EXPERIMENTAL

Anti-CD19 Autologous CAR-T Cell Infusion

Intervention Type: BIOLOGICAL

Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform

Interventions

Anti-CD19 Autologous CAR-T Cell Infusion

Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform

Intervention Type: BIOLOGICAL

Other Intervention Names

OlyCAR-019

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanbin Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sanbin Wang, Professor

Role: CONTACT

Sanbin1011@163.com

13187424131 ext. +86

Shiqi Li, MD

Role: CONTACT

Lystch@qq.com

15398671578

Facility Contacts

Lihua Zhang

Role: primary

zhanglihua95@126.com

64774204 ext. +0871

Other Identifiers

KM-PBC920

Identifier Type: -

Identifier Source: org_study_id