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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCART22 | Biological | Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 Months |
| Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs) | Up to D28 post initial UCART22 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL) | At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24 | |
| Duration of Response | 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 |
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Inclusion Criteria:
Exclusion Criteria:
-Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cellectis Central Contact | Contact | +1 (347) 752-4044 | clinicaltrials@cellectis.com |
| Name | Affiliation | Role |
|---|---|---|
| Nitin Jain, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles (UCLA) - Medical Center | Recruiting | Los Angeles | California | 90095 | United States |
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| CLLS52 | Biological | A monoclonal antibody that recognizes a CD52 antigen |
|
|
| Progression Free Survival | 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 |
| Overall Survival | From the first day of study treatment to the date of death from any cause, assessed up to Month 24 |
| Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion | Lymphodepletion to Day 56 |
| University of Colorado - Aurora Cancer Center | Recruiting | Aurora | Colorado | 80045 | United States |
| Sarah Cannon - Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
| University of Chicago | Recruiting | Chicago | Illinois | 60647 | United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Roswell Park Comprehensive Cancer Center | Recruiting | Buffalo | New York | 14263 | United States |
| Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10021 | United States |
| Weill Medical College of Cornell University | Withdrawn | New York | New York | 10065 | United States |
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon - HCA Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| Sarah Cannon - St. David's South Austin Medical Center | Recruiting | Austin | Texas | 78704 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Sarah Cannon - Texas Transplant Institute at Methodist Hospital | Recruiting | San Antonio | Texas | 78229 | United States |
| University of Wisconsin Carbone Cancer Center | Recruiting | Madison | Wisconsin | 53792 | United States |
| CHU de Nantes - Hôtel-Dieu | Recruiting | Nantes | 44093 | France |
| Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie | Recruiting | Paris | 75010 | France |
| Hôpital Robert Debré - Service d'hémato-immunologie | Recruiting | Paris | 75019 | France |
| Hôpital Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
| CHU Rennes - Hopital Pontchaillou | Recruiting | Rennes | 35033 | France |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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