Clinical trial · Interventional
CD19-redirected Autologous Cells (CAR-CD19 T Cells)
Autologous T Cells With a Chimeric Antigen Receptor in Patients With CD19-positive Malignant B Cell Leukemia and Lymphoma
NCT02933775CI-TRIAL-00024278unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is designed for determining the safety and relative engraftment levels of the redirected autologous T cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell leukemia and malignant lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD19 Positive Malignant B-cell Leukemia and Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-CD19 T cells | Genetic | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-CD19 T cells
- description
- Autologous T Cells with a CD19-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection. Lymphodepleting conditioning regimen: A combination of fludarabine and cyclophosphamide will be administered at Day -9 - Day -4.
- interventionNames
- Genetic: CAR-CD19 T cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Study related adverse events
- timeFrame
- 24 weeks
- description
- Occurrence of study related adverse events, defined as NCI CTC ≥ Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible, likely or definitely related to study treatment at any time from the infusion until week 24, including infusional toxicity and any toxicity possibly related to the CAR-CD19 T cells.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with documented CD19-positive malignant B cell leukemia and lymphoma. 1. Patients aged between 18 \~ 65 with malignant B cell leukemia and lymphoma. 2. CD19-positive B cell leukemia or lymphoma. 3. Expected survival \> 12 weeks. 4. ECOG scores 0-1, or KPS scores \> 80. 5. Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis. 6. WBC ≥ 2.5×109/L; LY ≥ 0.7×109/L; LY% ≥ 15%. 7. Creatinine ≤ 2.0 mg/dL (176.8 μmol/L). 8. ALT/AST ≤ 2.5 ULN. 9. Bilirubin ≤ 2.0 mg/dL (34.2 μmol/L). 10. Prothrombin Time (PT) : International Normalized Ratio (INR) \< 1.7, or PT is at most 4 s longer than normal value. All tests results should comply with the above criteria. No continuing supportive care is received. Exclusion Criteria: * 1\. CD19-negative B cell leukemia or lymphoma. 2. Feasibility assessment during screening demonstrates \< 5% transduction of target lymphocytes, or insufficient expansion (\< 5-fold) in response to αCD3/CD28 costimulation. 3\. Pregnant or lactating women. (The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.) 4. Active hepatitis B or hepatitis C infection. 5. HIV/AIDS infection. 6. Uncontrolled active infection. 7. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. 8\. Previously treatment with any gene therapy products. 9. Allergy to immunotherapy and associated drugs. 10. Patients with heart disease that is in need of treatment or with poorly controlled hypertension determined by investigators. 11\. Patients with unstable or active ulceration or with gastrointestinal bleeding. 12\. Patients with previous or planed organ transplantation. 13. Hyponatremia with concentration of sodium in the blood \< 125 mmol/L. 14. Serum potassium (baseline) \< 3.5 mmol/L (Patients can take potassium supplements to recover serum potassium level prior to participating the study). 15\. Patients need anticoagulant (e.g. Warfarin or heparin). 16. Patients need long-term antiplatelet agent (Aspirin, dose \> 300 mg/d; Clopidogrel, dose \> 75 mg/d). 17\. Any radiotherapy conducted within 4 weeks prior to blood sampling.
References
Publications (1)
- DERIVEDErnst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. PMID 34515338