Clinical trial · Interventional
Evaluation of CAR19 T-cells as an Optimal Bridge to Allogeneic Transplantation
COBALT: Evaluation of CAR19 T-cells as an Optimal Bridge to Allogeneic Transplantation
NCT02431988CI-TRIAL-00066042COBALTcompletedPhase 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)
The purpose of this study is to administer novel cluster of differentiation antigen 19 (CD19) specific Chimeric Antigen Receptor T-cells (CAR19 T-cells) to patients with relapsed or resistant Diffuse Large B Cell Lymphoma (DLBCL) to assess the safety and efficacy of this strategy as a bridge to allogeneic transplantation.
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 |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR19 T-Cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Leukapheresis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR19 T-cells
- description
- Patients will receive a single infusion of CAR19 T-cells following standard pre-conditioning with cyclophosphamide and fludarabine. The CAR19 T-cells are to be administered on day 0.
- interventionNames
- Procedure: Leukapheresis
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Biological: CAR19 T-Cells
Primary outcomes (3)
- measure
- Feasibility of adequate leucapheresis collection and generation of CAR19 T cells.
- timeFrame
- 1 month
- description
- The number of CAR19 T cells successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients registered).
- measure
- Toxicity evaluation following CAR19 T-cell administration.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 16-65 years 2. Confirmed diagnosis of CD19+ DLBCL 3. Primary resistant or relapsed disease failing to achieve metabolic Complete Response (CR) to 1st line salvage, or relapse post autograft failing to achieve metabolic CR following a single further cycle of salvage 4. Potential allogeneic transplant candidate 5. Agreement to have a pregnancy test, use adequate contraception for 12 months post-CAR19 T-cell infusion 6. Karnofsky performance status \>60 7. Written informed consent Exclusion Criteria: 1. Women who are pregnant or lactating 2. Prior allogeneic transplantation 3. Progressive disease following most recent salvage prior to planned leucapheresis (those with mixed response are eligible) 4. Prior history of ischaemic heart disease, dysrhythmias, abnormal electrocardiogram (ECG)(Left Bundle Branch Block (LBBB)), Multiple Gated Acquisition (MUGA) left ventricular ejection fraction (LVEF) \<40% 5. Exclusions for proceeding to allogeneic transplantation (active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV); liver function test (LFT) \>3 x upper limit of normal (ULN); Creatinine Clearance (CrCl) \<40 ml/min; or other comorbidity that precludes transplantation) 6. Known central nervous system (CNS) involvement or cerebral vascular accident (CVA) within prior 3 months 7. Patients receiving corticosteroids at a dose of \> 10mg prednisolone per day (or equivalent) 8. Use of rituximab within the last 2 months prior to CAR19 T-cell infusion 9. Active autoimmune disease requiring immunosuppression 10. Life expectancy \<3 months 11. Known allergy to albumin or dimethylsulfoxide (DMSO) 12. Any contraindication to the administration and use of ifosfamide, epirubicin, etoposide, fludarabine and cyclophosphamide.
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