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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Feb 17, 2026

Start date

Sep 1, 2026

Status verified

Feb 2026

Primary completion

Sep 1, 2028

Completion

Sep 1, 2029

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

1. Clinical Safety Outcome (Pilot Cohort) [ Time Frame: This outcome will be assessed 30 days post-infusion. ]

Central Contacts

• Beatriz Wills, MD - IP
  +57 601 4817000
  [email protected]
• Xiomara Olaya, Enf. MsC - IDCBIS
  +57 601 3649620
  [email protected]

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