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

C

Cellectis

Status and phase

Enrolling
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)

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

Trial contacts and locations

17

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Central trial contact

Cellectis Central Contact

Data sourced from clinicaltrials.gov

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