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

Cellectis

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: B-cell Acute Lymphoblastic Leukemia

Treatments: Biological: CLLS52; Biological: UCART22

Study type: Interventional

Funder types: Industry

Identifiers

NCT04150497

UCART22_01

Details and patient eligibility

About

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)

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

-Prior cellular therapy or investigational cellular or gene therapy within 60 days prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Dose Escalation

Experimental group

Description:

Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified and establish Recommended Phase 2 Dose (RP2D) Dose Expansion: UCART22 administered at the RP2D

Treatment:

Biological: UCART22

Biological: CLLS52