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Dual Anti-CD22/CD19 Chimeric Antigen Receptor-directed T Cells (CART2219.1) for Relapsed Refractory B-Lineage Leukaemia

NCT05429905 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-03-09

No results posted yet for this study

Summary

The purpose of this study is to deliver dual-targeting CAR-T cell therapy (CART 2219.1) as a salvage treatment to patients with relapsed/refractory B-lineage leukaemia in place of stem cell transplant or irradiation.

Conditions

  • Lymphoblastic Leukemia
  • Lymphoblastic Leukemia, Acute, Childhood
  • Lymphoblastic Leukemia in Children
  • Lymphoblastic Leukemia, Acute Adult
  • CAR

Interventions

BIOLOGICAL

Phase I

* Dose level 0: CAR+CD3+ 0.4 x 10e6/kg (de-escalation dose) * Dose level 1: CAR+CD3+ 1 x 10e6/kg (starting dose) * Dose level 2: CAR+CD3+ 2.5 x 10e6/kg. Dose-escalations for adults and paediatrics will be performed in 2 independent strata for determination of RP2D.

BIOLOGICAL

Phase II

RP2D will be determined in Phase I

Sponsors & Collaborators

  • Singapore General Hospital

    collaborator OTHER

  • National University Hospital, Singapore

    collaborator OTHER

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Michaela Seng, MD · KK Women's and Children's Hospital, BMTCT

  • Wing Hang Leung, MD PhD · KK Women's and Children's Hospital, BMTCT

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Singapore

Study Locations

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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 NCT05429905 on ClinicalTrials.gov