Health TrialsbyHealthPanel

Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

ConditionB-cell Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age15-50
SponsorCellectis S.A.

About this trial

This is a 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 and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

B-ALL blast cells expressing CD22

Diagnosed with R/R B-ALL

Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • UCART22

    Biological/Vaccine

    Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen

  • CLLS52

    Biological/Vaccine

    A monoclonal antibody that recognizes a CD52 antigen

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Dose EscalationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of AE/SAE/DLT [Safety and Tolerability]

Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion

Time frame
24 Months
2

Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)

Time frame
Up to D28 post initial UCART22 infusion

Secondary outcomes

1

Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)

Time frame
At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24
2

Duration of Response

Time frame
From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
3

Progression Free Survival

Time frame
From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
4

Overall Survival

Time frame
From the first day of study treatment to the date of death from any cause, assessed up to Month 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cellectis S.A.

Lead sponsor

Source ClinicalTrials.gov
Apply now