Actively Recruiting
BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma
Led by Chinese PLA General Hospital · Updated on 2025-06-25
30
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this single-center, single-arm, prospective, Phase 1/2 study, the safety and efficacy of autologous BCOR and ZC3H12 genes knock-out CD19-targeting chimeric antigen receptor (CAR) T-cell therapy will be evaluated in patients with refractory/relapsed (r/r) B-cell Lymphoma. For simplicity, we have termed these CD19 CAR T cells lacking ZC3H12A and BCOR as CAR19TIF( immortal-like and functional CD19 CAR T ) cells, reflecting their immortal-like and functional characteristics. In phase 1, 3 eligible patients will be enrolled and receive CAR19TIF cells at a initial dose of 5×10\^5 cells/kg. Based on the results, subsequently an additional 3-15 patients will be enrolled in a "3+3" dose-escalation/decline design to adjust the dose of CAR19TIF cells to achieve optimal safety and efficacy. The recommended Phase 2 dose (RP2D) will then be established. 10 to 12 subjects will be enrolled and receive CAR19TIF cells infusion at dose of RP2D.
CONDITIONS
Official Title
BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old (inclusive).
- Histologically confirmed refractory or relapsed B-cell Non-Hodgkin's lymphoma including DLBCL NOS, PMBCL, TFL, HGBCL, FL, MCL, and Marginal zone lymphoma.
- Relapsed disease defined as progression after remission with latest standard treatment.
- Refractory disease defined as no complete response to first-line therapy or progression as specified.
- Intolerance to standard treatment allowed per investigator judgment.
- Prior therapy for MCL must include anthracycline or bendamustine chemotherapy, anti-CD20 monoclonal antibody (unless tumor is CD20-negative), and BTK inhibitor.
- Prior therapy for other types must include anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and anthracycline chemotherapy.
- Transformed follicular lymphoma must have relapsed or refractory disease after transformation to DLBCL.
- At least one measurable lesion by size criteria.
- CD19 positive by immunohistochemistry.
- Stable toxicities from prior therapy recovered to grade 1 or less, except hematologic and alopecia.
- ECOG performance status 0 to 2.
- Adequate blood counts with specified minimums.
- Adequate kidney, liver, lung, and heart function within defined limits.
- Willingness to practice birth control and negative pregnancy test if applicable.
- Voluntary informed consent.
You will not qualify if you...
- Expected survival less than 3 months.
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ unless disease free for 3 years.
- History of allogeneic stem cell or organ transplantation.
- Prior CD19 targeted therapy.
- Recent chemotherapy, monoclonal antibodies, or radiotherapy within specified timeframes before lymphodepletion.
- Prior CAR-T or genetically modified T cell therapy.
- Presence of malignant cells in cerebrospinal fluid, brain metastases, or CNS lymphoma history.
- Severe allergic reaction to lymphodepletion drugs or CAR19TIF components.
- Uncontrolled or requiring IV treatment infections.
- Active infections including HIV, hepatitis B/C, EBV, or CMV.
- CNS disorders including seizures, stroke, dementia, or autoimmune CNS disease.
- Cardiac lymphoma involvement or significant cardiac disease within 12 months.
- Oncologic emergencies requiring urgent therapy within 6 weeks.
- Primary immunodeficiency.
- Autoimmune disease causing organ injury or needing systemic immunosuppression within 2 years.
- Recent deep vein thrombosis or pulmonary embolism needing anticoagulation.
- Any condition interfering with safety or efficacy assessment.
- Severe allergic reactions to study agents.
- Vaccinations within 6 weeks before conditioning.
- Unlikely to complete study visits or comply with requirements.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
W
Weidong Han, Ph.D
CONTACT
Y
Yang Liu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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