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CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol | Clinical Trials | Clareo Health

RECRUITINGPHASE2

CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol

NCT05648019•KK Women's and Children's Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.

Detailed Description

This is a single arm, open-label, multi-center, phase II feasibility study to deliver point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma. The study consists of the following phases: 1. Screening phase: Eligibility; enrolment 2. Preparatory phase: Bridging therapy (if required); leukapheresis; CAR T manufacturing; lymphodepletion. 3. Treatment phase: Infusion of single dose of anti-CD19 CAR T-cells 4. Follow-up Phase: Efficacy and safety monitoring up to 24 months

Eligibility

Age

0 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Eligible disease conditions:
•1. Relapsed or refractory B-cell ALL (all must be satisfied)
•* Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.
•* Relapsed or refractory or ineligible for HSCT
•* For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry
•2. Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
•2. Age at screening:
•1. \< 18 years (paediatric group); or
•2. ≥ 18 years (adult group)
•3. Adequate organ functions:
+3 more criteria

Exclusion Criteria

•Patients with any of the following will be excluded:
•B-ALL with isolated extramedullary disease relapse
•Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.
•Patients with Burkitt's lymphoma/leukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell \[sIg positive and kappa or lambda restricted positivity\] ALL, with FAB L3 morphology and /or a MYC translocation)
•Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
•Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening
•Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)
•Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible.
•Patient has an investigational medicinal product within the last 30 days prior to screening.
•Pregnant or nursing women.
+4 more criteria

Locations (2)

Singapore General Hospital

Singapore, Singapore

KK Women's and Children's Hospital

Singapore, Singapore

Key Dates

Start Date

March 15, 2022

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

March 9, 2023

Enrollment

ESTIMATED participants

Conditions

Lymphoblastic LeukemiaLymphoblastic Leukemia in ChildrenLymphoblastic Leukemia, Acute AdultB-cell Acute Lymphoblastic LeukemiaLarge B-cell LymphomaCAR

Interventions

Anti-CD19 CAR T-cells

BIOLOGICAL

Contacts

Shui Yen Soh, MD

CONTACT

+65 6394 1045 soh.shui.yen@singhealth.com.sg

Germaine Liew, BS

CONTACT

+65 6394 5025 germaine.liew.shimin@singhealth.com.sg

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol

Inclusion Criteria

Exclusion Criteria

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