Actively Recruiting
BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL
Led by Chinese PLA General Hospital · Updated on 2025-06-25
30
Participants Needed
2
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 acute lymphoblastic leukaemia (B-ALL). In phase 1, 3 eligible patients will be enrolled and receive BCOR and ZC3H12 genes knock-out CD19 CAR T cell therapy 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 BCOR and ZC3H12 genes knock-out CD19 CAR T 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 BCOR and ZC3H12 genes knock-out CD19 CAR T cell infusion at dose of RP2D.
CONDITIONS
Official Title
BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, any gender
- Diagnosis of refractory or relapsed CD19-positive B-cell acute lymphoblastic leukemia
- At least 5% leukemic blasts in bone marrow or measurable minimal residual disease after last induction treatment
- Exhausted alternative treatment options
- Relapsed disease defined as second or later bone marrow relapse or any relapse after allogenic stem cell transplant
- Refractory disease defined as failure to achieve complete remission after two chemotherapy cycles or chemorefractory after initial remission
- Toxicities from prior therapy must be stable and recovered to Grade 1 or less (except certain non-significant toxicities)
- ECOG performance status 0 to 2
- Adequate kidney, liver, lung, and heart function as defined by laboratory and clinical criteria
- Oxygen saturation over 91% on room air
- Willingness to use birth control during consent through 6 months after chemotherapy; females of childbearing potential must have a negative pregnancy test
- Ability to voluntarily participate and sign informed consent
You will not qualify if you...
- Expected survival less than 3 months
- Prior or current cancer within 3 years except certain treated skin, cervical, or bladder cancers
- Previous CD19-targeted therapy or CAR T-cell/genetically modified T cell therapy
- Active central nervous system leukemia (CNS-3) or suspected extra-medullary involvement
- Burkitt cell or mixed lineage acute leukemia
- Significant CNS disorders or irreversible neurological toxicity
- Recent radioimmunotherapy or radiotherapy within 8 weeks (except CNS prophylaxis)
- Use of anti-leukemic therapy within 5 half-lives before CAR19TIF administration
- Severe allergic reactions to lymphodepletion drugs or CAR19TIF components
- Uncontrolled infections requiring intravenous treatment
- Active infectious diseases like HIV, hepatitis B or C, EBV, or CMV
- Cardiac lymphoma involvement or serious heart disease within 12 months
- Need for urgent therapy due to oncologic emergency within 6 weeks
- Primary immunodeficiency
- Autoimmune disease causing organ injury or needing systemic immunosuppression within 2 years
- Recent symptomatic deep vein thrombosis or pulmonary embolism requiring anticoagulation
- Any medical condition interfering with safety or efficacy assessments
- Vaccination within 6 weeks before conditioning chemotherapy
- Unlikely to complete study visits or comply with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
China
Beijing, Biotherapeutic Department of Chinese PLA General Hospital, China
Actively Recruiting
2
China
Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital, China
Not Yet 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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