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

NCT02431988 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-04-28

No results posted yet for this study

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.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

PROCEDURE

Leukapheresis

Patients will undergo leukapheresis prior to pre-conditioning chemotherapy to provide the immune cells required to produce the therapeutic product.

DRUG

Cyclophosphamide

Patients will receive a standard pre-conditioning regime with cyclophosphamide 60mg/kg/day IV over 1 hour for 2 days (day-7 and day-6).

DRUG

Fludarabine

Fludarabine 25mg/m2/day IV over 15/30 minutes for 5 days (Day-5 to day-1).

BIOLOGICAL

CAR19 T-Cells

The CAR19 T-cells are to be administered on day 0 at the dose specified by the Cancer Trials Centre (CTC) at the time of registration. Three dose cohorts are planned: * Dose Level 1: 2x105 CAR19 T-cells/kg * Dose Level 2: 1x106 CAR19 T-cells/kg * Dose Level 3: 5x106 CAR19 T-cells/kg

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Karl Peggs · University College, London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-02-02
Completion
2022-03-21

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431988 on ClinicalTrials.gov