NCT05648019

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
7mo left

Started Mar 2022

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Mar 2022Dec 2026

Study Start

First participant enrolled

March 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

3.7 years

First QC Date

August 1, 2022

Last Update Submit

March 7, 2023

Conditions

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

Keywords

CAR T-cell therapyRelapse/RefractoryB-ALLB-Lineage Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Protocol Feasibility

    To describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma by assessing number and percentage of enrolled patients who have successful manufacturing of CAR T-cell product, and number and percentage of enrolled patients who go on to receive the CAR T-cell product.

    3 years

Secondary Outcomes (2)

  • Overall Response Rate

    6 months

  • Toxicity Evaluations

    6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

CD19-directed CAR T-cell therapy for relapsed/refractory B-lineage leukaemia/lymphoma.

Biological: Anti-CD19 CAR T-cells

Interventions

Anti-CD19 CAR T-cellsBIOLOGICAL

A target per-protocol dose of vi able CD19 CAR transduced T-cells will consist of a single infusion of 0.2 to 5.0 x 10e6 lentiviral-transduced viable 41BB-CD19 CAR T-cells per kg body weight.

Single Arm

Eligibility Criteria

Age0 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible disease conditions:
  • 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
  • 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.
  • Age at screening:
  • \< 18 years (paediatric group); or
  • ≥ 18 years (adult group)
  • Adequate organ functions:
  • Life expectancy more than 12 weeks.
  • Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening.
  • Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.

You may not qualify if:

  • 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.
  • Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells.
  • Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
  • Treatment with any prior gene therapy product
  • Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaRecurrence

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shui Yen Soh, MD

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Aloysius Ho, MD

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shui Yen Soh, MD

CONTACT

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

Germaine Liew, BS

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

December 13, 2022

Study Start

March 15, 2022

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations

SG(2)