This Clinical Trial is a Single-arm, Non-randomized Pilot Trial to Determine the Safety of Administering Autologous Anti-C19 Cells (ARI-0001) and the Feasibility of Local CAR-T Cell Production in Patients Over 18 Years of Age With Relapsed/Refractory (R/R) CD19+ Hematologic Malignancies, Including R

NCT07412405 | Not Yet Recruiting DMC

• 2 other identifiers: ACITAC-001-CART-19-ARI0001ACITAC-001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a hybrid type two study, with two simultaneous development phases. Phase A involves developing a public-private partnership to create the conditions for implementing CAR-T cell therapies in Colombia. Phase B will be a single-arm, non-randomized pilot clinical trial in patients over 18 years of age with recurrent/refractory (R/R) CD19+ hematopoietic lymphoid neoplasms, including R/R non-Hodgkin lymphoma (NHL), R/R B-cell acute lymphoblastic leukemia (B-ALL), and R/R mantle cell lymphoma; and R/R chronic lymphocytic leukemia (CLL) (including CLL with Richter transformation). This trial aims to determine the safety of administering autologous anti-C19 cells (ARI-0001) and the feasibility of local CAR-T cell production. Phase A of implementation aims to gather information on the domains of the multilevel model, including organizational context, suppliers, infrastructure, and institutional capacities, to identify barriers and facilitators in the implementation of CAR-T cell therapy in Colombia. National consensus will also be developed in the scientific, clinical, administrative, and regulatory spheres. Phase B will involve a pilot clinical trial in patients with relapsed/refractory CD19-positive hematopoietic lymphoid neoplasms. The production of ARI-0001 cells consists of the genetic modification of autologous T cells through lentiviral transduction of a chimeric antigen receptor (CAR) targeting the CD19 surface antigen. The process is carried out in the CliniMACS Prodigy® closed transduction system, which for this study will be located at and operated by staff from the District Institute of Science, Biotechnology, and Innovation in Health (IDCBIS). This pilot clinical trial will use an open-label, single-arm, staggered enrollment design with a safety observation period. The patient will receive the cell product infusion following administration of a lymphodepletion regimen at the National Cancer Institute (NCI). The patient will remain hospitalized for 14 days after the CAR-T cell infusion ARI-001 for medical monitoring, with subsequent outpatient follow-up until 12 months post-infusion. Subsequently, the patient will be offered a new informed consent process to participate in outpatient follow-up for up to 15 years.

Conditions

Adult B-cell Acute Lymphoblastic Leukemia; Follicular Lymphoma (FL); Mantle Cell Lymphoma (MCL); Diffuse Large B-Cell Lymphoma (DLBCL); Chronic Lymphocytic Leukemia

Keywords

Pilot; Implementation; Safety; ARI-0001; CAR-T; CD19; Lymphoma; Leukemia; Colombia

Outcome Measures

Primary Outcomes (3)

• 1. Clinical Safety Outcome (Pilot Cohort)

  Proportion of patients experiencing grade ≥3 treatment-related adverse events, including cytokine release syndrome (CRS), CAR-T cell-associated neurotoxicity (ICANS), and prolonged cytopenias beyond 30 days post-infusion (ICAHT).

  This outcome will be assessed 30 days post-infusion.

• 2. Clinical Safety Outcome (Pilot Cohort)

  Proportion of patients developing infections within the first 12 months after CAR-T cell infusion.

  12 months after CAR-T cell infusion.

• 3. Clinical Safety Outcome (Pilot Cohort)

  Early mortality, defined as death occurring within the first 30 days post-infusion.

  30 days post-infusion.

Secondary Outcomes (3)

• Overall response rate (ORR)

  at 28 and 100 days post - infusion

• Disease-free survival (DFS)

  at 12 and 24 months post - infusion

• Overall survival (OS)

  at 12 and 24 months post-infusion

Other Outcomes (3)

• Exploratory Outcomes: Persistence of ARI-0001 CAR-T cells in peripheral blood

  at 28, 100, 180, and 360 days post-infusion.

• Exploratory Outcomes: Direct and indirect costs

  Through study completion, an average of 1 year

• Exploratory Outcomes: Immunological profile and inflammatory markers

  on days +28, +100, and +360.

Study Arms (1)

Single-arm, non-randomized pilot clinical trial in patients aged between 18 and 80 years

EXPERIMENTAL

Patients over 18 years of age with recurrent/refractory (R/R) CD19+ hematopoietic lymphoid neoplasms, including R/R non-Hodgkin lymphoma (NHL), R/R B-cell acute lymphoblastic leukemia (B-ALL), and R/R mantle cell lymphoma; and R/R chronic lymphocytic leukemia (CLL) (including CLL with Richter transformation). 1. Collection of autologous T lymphocytes by apheresis Day -4 ± 7 2. Transport of cellular material to IDCBIS 3. Manufacture of ARI-0001 using CliniMACS Prodigy according to GMP 4. Cryopreservation of ARI-0001 cells 5. Transport of ARI-0001 cells to the INC 6. Temporary storage of ARI-0001 cells at the INC 7. Administration of lymphodepletion regimen to patient Days -5, -4, -3 8. Thawing of ARI-0001 cell product 9. ARI-0001 infusion Days 1, 2, 3 10. Outpatient follow-up 11. Inpatient monitoring for 14 days 12. Collection of samples for paraclinical analysis Days 4-7, 9, 12, 14 13. Visit on day 22, biweekly days 22-90, monthly days 91-360

Biological: ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T)

Interventions

ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T) BIOLOGICAL

Pilot clinical trial ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T) treatment of recurrent/refractory CD19+ hematolymphoid neoplasms.

Single-arm, non-randomized pilot clinical trial in patients aged between 18 and 80 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants (Men and Women) ≥ 18 and ≥ 80 years of age.
• Participants capable of understanding and voluntarily signing the informed consent forms (prescreening and study forms) prior to any study-related evaluation or procedure, and able to adhere to the study visit schedule and other protocol requirements.
• CD19+ hematologic malignancy with a histologically documented diagnosis.
• B-cell precursor acute lymphoblastic leukemia (B-ALL relapsed/refractory (R/R)): Second-line or later relapse (including patients with prior blinatumumab use), second-line or later non-candidate for allogeneic transplantation, or relapse post-allogeneic transplantation.
• The consideration of non-candidacy for allogeneic transplantation will be based on functional status, comorbidities, and persistence. Minimal Residual Disease (MRD) or lack of a donor.
• Relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma (R/R): Refractory to first-line treatment or relapsed within the first 12 months after completion of first-line chemoimmunotherapy, including an anti-CD20 monoclonal antibody, not a candidate for autologous transplantation; or refractory after two or more lines of systemic therapy; in second (or higher) relapse post-autologous transplantation; grade 3b follicular lymphoma or transformed to relapsed or refractory large B-cell lymphoma after at least one line of standard treatment.
• Symptomatic relapsed/refractory follicular lymphoma (FL): In third-line therapy (after at least two treatment regimens), including anti-CD20 therapy, and with a progression-free interval of less than two years; or in Relapse after autologous or allogeneic transplantation.
• Relapsed/refractory (R/R) mantle cell lymphoma, including Bruton's tyrosine kinase inhibitor (BTKi) therapy: In first (or higher) relapse, not a candidate for autologous or allogeneic transplantation; or in second (or higher) relapse following autologous or allogeneic transplantation.
• Eastern Cooperative Oncology Group (ECOG) functional status ≤ 2.
• Life expectancy \> 6 months, as determined by the Principal Investigator.
• Adequate organ function, defined as the following parameters at visit 2 Selection criteria:
• Absolute neutrophil count (ANC) ≥ 1,000/mm3
• Platelet count ≥ 50,000/mm3
• Hemoglobin ≥ 10 g/dL
• Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN).

You may not qualify if:

• The presence of any of the following will exclude the subject from trial enrollment:
• Failure to comply with the washout periods.
• Autologous or allogeneic stem cell transplantation or CAR-T cell therapy within 6 weeks prior to CAR-T cell infusion.
• Subjects with an active infection requiring systemic treatment. This definition excludes participants with Hepatitis B (known positive hepatitis B surface antigen \[HBsAg\] result), latent Tuberculosis, Hepatitis C, or HIV seropositivity.
• History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) requiring immunosuppressive medication within the past 6 months.
• Pregnant or breastfeeding women are excluded from this trial because CAR-T cell therapy may be associated with teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Due to the unknown, but potential, risk of adverse events in infants from maternal CAR-T cell therapy, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this trial.
• Participation in another interventional research study.
• Major surgery within 4 weeks prior to enrollment from which the patient has not fully recovered, as determined by the investigator.
• Active central nervous system (CNS) involvement due to leukemia or lymphoma, including leptomeningeal lymphoma. Patients with a history of CNS or meningeal involvement must be in documented remission, as determined by cerebrospinal fluid (CSF) evaluation, for at least 90 days prior to enrollment.
• Diagnosis of another malignancy within ≤ 5 years prior to trial enrollment, except for those considered adequately treated with no evidence of disease or symptoms and/or not requiring therapy during the trial (e.g., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder, or cervix, or low-grade prostate cancer with a Gleason score ≤ 6).
• Known brain metastases or cranial epidural disease. Note: Patients with brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks prior to the first dose of trial treatment will be eligible for the trial. Subjects must be neurologically asymptomatic and not receiving corticosteroid treatment at the time of the first dose of trial treatment.
• Current evidence of significant uncontrolled comorbidity, including, but not limited to, the following conditions:
• New York Heart Association Class III or IV congestive heart failure, unstable angina, serious cardiac arrhythmias.
• Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism) within 3 months prior to the first dose.
• QTc prolongation defined as QTcF \> 500 ms.

Sponsors & Collaborators

• GUSTAVO SALGUERO: lead
• Instituto Nacional de Cancerologia, Columbia: collaborator

Related Links

• Research center
• Centro de manufactura

MeSH Terms

Conditions

Burkitt Lymphoma; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gustavo Salguero, MD PhD MBA

  Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS

  STUDY DIRECTOR

Central Study Contacts

Beatriz Wills, MD - IP

CONTACT

+57 601 4817000; bwills@cancer.gov.co

Xiomara Olaya, Enf. MsC - IDCBIS

CONTACT

+57 601 3649620; ensayosclinicosuta@idcbis.org.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/D
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Model Details: Hybrid type two study (implementation of CAR-T therapy in Colombia and pilot clinical trial ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T) for the treatment of recurrent/refractory CD19+ hematolymphoid neoplasms.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: February 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02