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Phase I Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

NCT04150497

Description:

This is a Phase I, first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety, tolerance, clinical activity of UCART22 and to determine the Maximum Tolerated Dose (MTD).

Related Conditions:
  • Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase I Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
  • Official Title: Phase I, Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

Clinical Trial IDs

  • ORG STUDY ID: UCART22_01
  • NCT ID: NCT04150497

Conditions

  • B-cell Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
UCART22Dose Escalation

Purpose

This is a Phase I, first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety, tolerance, clinical activity of UCART22 and to determine the Maximum Tolerated Dose (MTD).

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalPart 1: Dose Escalation One administration of UCART22 in the dose escalation phase will explore 4 doses of UCART22 and continue until the Maximum Tolerated Dose (MTD) is identified. Part 2: Dose Expansion One administration of UCART22 at the MTD.
  • UCART22

Eligibility Criteria

        Inclusion Criteria:

          1. Relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) after at least
             one standard chemotherapy regimen and one salvage regimen

          2. Eastern Cooperative Oncology Group performance status of 0 or 1

          3. No organ dysfunction that in the opinion of the investigator precludes intensive
             induction chemotherapy or cellular therapy
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of AE/SAE/DLT [Safety and Tolerability)
Time Frame:24 Months
Safety Issue:
Description:Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cellectis S.A.

Trial Keywords

  • BALLI-01
  • B-cell Acute Lymphoblastic Leukemia (B-ALL)
  • Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy
  • Allogeneic
  • Transcription Activator-Like Effector Nuclease (TALEN®)

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