Evaluation of CAR19 T-cells as an Optimal Bridge to Allogeneic Transplantation

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

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.