Clinical trial · Interventional
Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
A Phase II/III Prospective, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed/ Refractory B-Acute Lymphoblastic Leukaemia
NCT03937544CI-TRIAL-00090305recruitingPhase 2 / Phase 3ClinicalTrials.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 is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia
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 |
|---|---|---|---|
| Refractory B Acute Lymphoblastic Leukaemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Relapsed B Acute Lymphoblastic Leukaemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR-T CELLS | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19 CAR-T CELLS
- description
- A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
- interventionNames
- Biological: CD19 CAR-T CELLS
- Drug: Cyclophosphamide
- Drug: Fludarabine
Primary outcomes (3)
- measure
- Overall response rate (ORR)
- timeFrame
- Participants will be followed for the duration of the treatment, with an expected average of 3 months.
- description
- Overall Response Rate (ORR) defined as Complete Response (CR) and CR with incomplete blood recovery (CRi) according to WHO criteria.
- measure
- Complete response (CR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with relapsed/refractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry, cytogenetics and molecular genetics * Age between ≥13 to ≤ 65 years * No detectable leukaemia in the CSF (CNS-1) * CNS leukaemia without clinically evident neurological symptoms (CNS-2; with \<5 WBC per μL and cytology positive for blasts) * Adequate organ function as defined by a creatinine clearance \> 50 ml/min, serum total bilirubin \< 5 times the normal value, left ventricular ejection fraction \> 40% * ECOG performance status ≤ 2 * Life expectancy \> 3 months * Post allogeneic HSCT must be ≥ Day +100 with no evidence of active GVHD and not receiving immunosuppression * Female patients of child bearing age must have negative pregnancy test and is on highly effective contraception methods * Male patients must use highly effective contraception methods Exclusion Criteria: * Patients with CNS-3 leukaemia. * Active cancer (other than B-ALL). * Evidence of severe lung, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder. * Presence of active autoimmune disease or atopic allergy. * HIV serology positivity. * Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay. * Uncontrolled sepsis * Pregnant / nursing female. * Ongoing prednisolone \> 1mg/kg daily or equivalent. * Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.