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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cellectis S.A.
Study ID
NCT04150497
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
15 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • UCART22 — BIOLOGICAL
    Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
  • CLLS52 — BIOLOGICAL
    A monoclonal antibody that recognizes a CD52 antigen

Study Details

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)

Key Dates

Start date
Oct 14, 2019
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    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

Primary Outcome Measure

Incidence of AE/SAE/DLT [Safety and Tolerability] [ Time Frame: 24 Months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of California, Los Angeles (UCLA) - Medical CenterLos AngelesCalifornia90095-
University of Colorado - Aurora Cancer CenterAuroraColorado80045-
Sarah Cannon - Colorado Blood Cancer InstituteDenverColorado80218-
University of ChicagoChicagoIllinois60647-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Weill Medical College of Cornell UniversityNew YorkNew York10065-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Sarah Cannon - HCA Research InstituteNashvilleTennessee37203-
Sarah Cannon - St. David's South Austin Medical CenterAustinTexas78704-
MD Anderson Cancer CenterHoustonTexas77030-
Sarah Cannon - Texas Transplant Institute at Methodist HospitalSan AntonioTexas78229-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles (UCLA) - Medical Center· Los Angeles, CAUniversity of Colorado - Aurora Cancer Center· Aurora, COSarah Cannon - Colorado Blood Cancer Institute· Denver, COUniversity of Chicago· Chicago, ILDana Farber Cancer Institute· Boston, MARoswell Park Comprehensive Cancer Center· Buffalo, NY

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