Treatment of relapsed/refractory B-Cell malignancies with a novel CAR-T therapy
An Open Label, Single-site, Dose-escalation Study Aiming to Evaluate the Efficacy and Safety of Anti-CD19 CAR-T Manufactured by OlyCAR Platform(OlyCAR-019) in the Treatment of Relapsed/ Refractory(r/r) B-Cell Malignancies
This study is testing a new CAR-T therapy called OlyCAR-019 to see if it can help people with tough-to-treat B-Cell cancers feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 75 Years |
| Sex | All |
| Sponsor | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine, prednisone, CAR-T |
| Locations | 1 site (Kunming, Yunnan) |
| Trial ID | NCT05932173 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a novel anti-CD19 CAR-T therapy, OlyCAR-019, in patients with relapsed or refractory B-Cell malignancies. It is a single-center, open-label, single-arm trial where patients will receive an infusion of CAR-T cells manufactured using the OlyCAR platform. Participants will be monitored for safety and efficacy for up to 12 weeks, with extended follow-up for those achieving durable remission. The study aims to assess the feasibility of this rapid CAR-T cell production method in treating B-Cell cancers.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2-75 with relapsed or refractory B-Cell malignancies and detectable disease.
Not a fit: Patients with concurrent active malignancies or severe mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with difficult-to-treat B-Cell malignancies.
How similar studies have performed: Other studies have shown promise with CAR-T therapies, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kunming, Yunnan
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China — Kunming, Yunnan, China (Recruiting)
Study contacts
- Principal investigator: Sanbin Wang, Professor — 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Study coordinator: Sanbin Wang, Professor
- Email: Sanbin1011@163.com
- Phone: 13187424131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.