Clinical trial

Long-term Follow-up Study of Patients Who Have Previously Been Exposed to UCART19 (Allogeneic Engineered T-cells Expressing a Lentiviral-based Anti-CD19 Chimeric Antigen Receptor)

Name

CL1-68587-003

Description

The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.

Trial arms

Trial start

2021-03-10

Estimated PCD

2025-02-01

Trial end

2025-02-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

UCART19 follow-up

UCART19 will not be administered during the study period. Patients who will be rolled-over from the parent study to this long term follow-up study, have previously received UCART19. The roll-over occurs at the end of the parent study, or at any time after UCART19 administration, in case of premature discontinuation from the parent study.

Arms:

UCART19 follow-up

Size

Primary endpoint

Long-term safety of UCART19 with or without alemtuzumab

Up to 15 Year

Eligibility criteria

Inclusion Criteria: * Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative) * Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use); * Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners for a 12-month duration after the last UCART19 administration. Exclusion Criteria: - No exclusion criteria for this study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2023-09-13

1 organization

1 product

1 indication

Organization

Institut de Recherches Internationales Servier

Product

UCART19

Indication

Advanced Lymphoid Leukemia