Clinical trial · Interventional
Anti-CD19 CAR in PiggyBac Transposon-Engineered T Cells for Relapsed/Refractory B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia
A Phase I Clinical Trial of Anti-CD19 Chimeric Antigen Receptor in PiggyBac Transposon-Engineered T Cells for the Treatment of Patients With Relapsed/Refractory/High-risk B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Our previous study demonstrated that anti-CD19 chimeric antigen receptor in piggyBac transposon-engineered T cells have strong tumor-killing activity in vitro and therapeutic effects in cell line-derived xenograft models, and no obvious side effects such as neurotoxicity and cytokine storm occurred. Therefore, we want to evaluate the safety and clinical effect of anti-CD19 CAR-T cells in clinical trials.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD19 CAR-T Cells Injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-CD19 CAR-T Cells Injection
- description
- Anti-CD19 CAR-T Cells Injection, Dosage form:injection Dosage:1-2.5x10\^6/kg, 100ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes, Frequency: total one time
- interventionNames
- Biological: Anti-CD19 CAR-T Cells Injection
Primary outcomes (2)
- measure
- Grade and number of cytokine release syndrome and neurotoxic effects in participants receiving treatment
- timeFrame
- 14 day
- description
- Anti-CD19 CAR-T cells growing use requires further education/training and prompt management of safety and tolerability.
- measure
- Persistence of anti-CD19 CAR-T cells in participants
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients or their legal guardians voluntarily participate and sign the Informed Consent Document; 2. Male or female patients aged 18 to 70 years (inclusive); 3. Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program; 4. B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:1) B-cell acute lymphoblastic leukemia;2) Indolent B-cell lymphomas;3) Aggressive B-cell lymphoma; 4) Multiple myeloma; 5. Subjects: (1) Residual lesions remain after treatment and Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (2) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (3) Patients with high risk factors; (4) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy. 6\. Have measurable or evaluable tumor foci; 7\. Liver, kidney and cardiopulmonary functions meet the following requirements: 1\) Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) \<3 ×upper limit of normal (ULN);2) Total bilirubin ≤34.2μmol/L;3) Serum creatinine\<220μmol/L;4) Baseline oxygen saturation≥95%;5) Left ventricular ejection fraction(LVEF)≥40%. 8\. Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss); 9\. Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 10\. Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2,Expected survival≥3 months; Exclusion Criteria: 1. Pregnant (urine/blood pregnancy test positive) or lactating women; 2. Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion; 3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment; 4. Active or uncontrollable infection within four weeks prior to enrollment; 5. Patients with active hepatitis B/C; 6. HIV-infected patients; 7. Severe autoimmune or immunodeficiency disorders; 8. Patients are allergic to macromolecule drugs such as antigens or cytokines; 9. Subjects participated in other clinical trials within 6 weeks before enrollment; 10. Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones); 11. Mental illness; 12. Drug abuse/addiction; 13. The investigators consider other conditions unsuitable for enrollment.
References
Publications (0)
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