Study of the Infusion of ARI-0001 Cells in Patients With CD19 + Acute Lymphoid Leukemia Resistant or Refractory to Therapy

NCT04778579 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CART19-BE-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

Brief Summary

To assess the efficacy (in terms of response rate and duration) of the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity \[A3B1\] conjugated to the 4-aBB and CD3z co-stimulatory regions) in patients with resistant or refractory CD19+ acute lymphoid leukemia

Conditions

Acute Lymphoid Leukemia

Outcome Measures

Primary Outcomes (1)

• Response rate

  • Response rate with measurable residual disease negative by multiparametric flow cytometry

  20 days after infusion

Study Arms (1)

ARI-0001

EXPERIMENTAL

After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused.

Drug: ARI-0001 cells

Interventions

ARI-0001 cells DRUG

Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z

Also known as: CART19, PEI 19-187

ARI-0001

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnoses of CD19+ acute lymphoid leukemia, with a life expectancy of less than 2 years that meet the following conditions:
• Relapsed/refractory not candidate for transplantation (due to associated diseases or absence of donor)
• in allogenic post-transplant relapse.
• Measurable disease understood as the presence of measurable residual disease by flow cytometry in bone marrow or peripheral blood
• Age less than 70 years (from 18 to 70).
• ECOG functional status from 0 to 2
• Life expectancy of at least 3 months.
• Adequate venous access to perform a lymphapheresis. Absence of contraindications for it.
• Signature of informed consent.

You may not qualify if:

• Treatment with any experimental or non-marketed substance within four weeks prior to recruitment, or actively participating in another therapeutic trial.
• Previous treatment with CART therapy (commercial or experimental)
• Diagnosis of another neoplasm, past or present. Patients may be included in complete remission for more than 3 years, or have a history of non-melanoma skin cancer or in-situ carcinoma resected completely.
• Isolated extramedullary involvement (i.e. in the absence of minimal residual disease in peripheral blood, bone marrow, or cerebrospinal fluid)
• Early relapse after transplantation (less than 3 months for mononuclear cell apheresis, less than 6 months for infusion of ARI-0001)
• Active infection requiring systemic medical treatment such as chronic kidney infection, chronic lung infection or tuberculosis.
• HIV infection.
• Positive serology for hepatitis B, defined as a positive test for HBsAg. In addition, if the patient is HBsAg negative but has anti-HBc antibodies it will be necessary to perform a DNA test of the hepatitis B virus, and if the result is positive the patient will be excluded
• Positive serology for hepatitis C, defined as a positive test for anti-VHC antibodies confirmed by RIBA
• Concurrent uncontrolled medical illnesses including cardiac, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological or psychiatric diseases that in the opinion of the investigator are potential risk factors to the patient.
• Severe organ involvement, defined as cardiac ejection fraction \<40%; DLCO \<40%; calculated glomerular filtrate \<30 ml/min; or bilirubin \> 3 times the upper limit of normality (unless Gilbert syndrome).
• Pregnant or lactating women. Woman of childbearing potential should have a negative pregnancy test in the screening phase.
• Women of childbearing potential, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods\* from the start of the study to the completion of the study.
• Men who cannot or do not wish to use highly effective contraceptive methods\* from the beginning of the study until the end of the study

Sponsors & Collaborators

• Sara V. Latorre: lead
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (9)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clínico Universitario Virgen de La Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital U. Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

CTL019 chimeric antigen receptor

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: May 11, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)