A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJuly 11, 2023
July 1, 2023
1 year
June 27, 2023
July 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Up to 12 months after infusion
MTD
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Up to 28 days after infusion
Secondary Outcomes (2)
Overall Response Rate (ORR)
Up to 3 months after infusion
Progression-free survival(PFS)
Up to 3 months after infusion
Study Arms (1)
OlyCAR-019 Cell Infusion
EXPERIMENTALOlyCAR-019 cell infusion will be administered by vein after short-time manufacture.
Interventions
Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform
Eligibility Criteria
You may qualify if:
- A definite diagnosis of relapsed/refractory B-cell malignancies;
- Male or female, aged 2-75 years;
- Confirmed detectable disease；
- Expected survival time \>12 weeks;
- Eastern cooperative oncology group (ECOG) score is 0-2;
- Adequate liver , kidney and cardiopulmonary function;
- 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;
- Willingness to complete the informed consent process and to comply with study procedures and visit schedule.
You may not qualify if:
- Presence of other concurrent active malignancy; People with severe mental disorders;
- 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;
- Acute GVHD of grade II-IV or extensive chronic GVHD;
- 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;
- 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;
- 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;
- 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);
- Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
- Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
- For patients contraindicated with cyclophosphamide and fludarabine chemotherapy;
- 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;
- Receiving donor lymphocyte infusion within 6 weeks before enrollment;
- Pregnant and lactating women;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, 650100, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanbin Wang, Professor
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
July 6, 2023
Study Start
July 1, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2025
Last Updated
July 11, 2023
Record last verified: 2023-07