Adult B-cell Acute Lymphoblastic LeukemiaACITAC-001NCT07412405
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
A study testing ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T) in people with Adult B-cell Acute Lymphoblastic Leukemia and Follicular Lymphoma (FL), run by GUSTAVO SALGUERO.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adult B-cell Acute Lymphoblastic Leukemia, Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL)
- What is being tested?
- ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Inclusion criteria according to the type of CD19+ hematologic malignancy measurable by the 2014 Lugano criteria (NHL) or IWCLL criteria (CLL) or EWALL criteria (ALL).
- 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.
- For patient inclusion, the disease must have progressed after the last regimen or the patient must not have achieved partial or complete remission with the last regimen, defined by the presence of at least 5% blasts in bone marrow or peripheral blood in an evaluation confirmed by flow cytometry or immunohistochemistry at least 2 weeks prior to recruitment (prescreening visit).
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- 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.
- Symptomatic chronic lymphocytic leukemia (CLL): Relapse after two treatment regimens (including BTKi and BCL2 inhibitor in combination with anti-CD20) and with a progression-free interval of less than two years (POD24); or transformation to Richter syndrome, see inclusion criteria for DLBCL.
- 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).
- AST (SGOT)/ALT (SGPT) ≤ 3 x the institutional ULN
- Serum creatinine ≤ 2 x the institutional ULN or eGFR > 30 mL/min/1.73 m2
- Left ventricular ejection fraction > 45% as determined by echocardiogram
- Pulmonary function tests: FEV1 (forced expiratory volume in 1 second): ≥ 50% of predicted and FVC (forced vital capacity): ≥ 50% of predicted Predicted value and FEV1/FVC ratio: ≥ 0.7 (or without significant obstruction) and SpO2 (oxygen saturation): ≥ 89% on room air at rest and hemoglobin-corrected DLCO: ≥ 70% of the predicted value.
- Have adequate venous access.
- Participants of reproductive potential must meet the following criteria:
- Negative pregnancy test 14 days before trial enrollment and subsequently every month for the duration of the trial, or evidence of postmenopausal status or surgical sterilization.
- Postmenopausal status is defined as the absence of menstruation for 12 months without an alternative medical cause. The following age-specific requirements apply:
- < 50 years: Amenorrhea for ≥12 months after discontinuation of exogenous hormonal treatments; and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range as defined by the institution.
- ≥ 50 years: Patient with amenorrhea for 12 months or more after discontinuation of all exogenous hormonal treatments; or radiation-induced menopause with last menstrual period more than 1 year ago; or chemotherapy-induced menopause with last menstrual period more than 1 year ago.
- All participants of reproductive potential and those with a sexual partner of reproductive potential must agree to use a highly effective contraceptive method from the start of trial therapy until 12 months after the last infusion dose. Options for adequate contraception with a failure rate of <1% per year include: bilateral tubal ligation/occlusion; partner vasectomy; intrauterine device (IUD) or hormonal delivery system (IUS); any hormonal contraceptive (estrogen combined with progesterone or progesterone alone) combined with ovulation inhibition: implanted, oral, intravaginal, transdermal, or injectable; spermicide with a compatible barrier method (e.g., diaphragm, sponge, or condoms). Alternatively, two methods (e.g., two barrier methods, such as a condom and a cervical cap) may be combined to achieve a failure rate of <1% per year. Barrier methods must always be supplemented with the use of spermicide. Abstinence is acceptable only if it is consistent with the patient's preferred and usual lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulatory methods) and withdrawal are not acceptable contraceptive methods. If pregnancy is suspected or confirmed in a female patient or a female partner of a male patient during trial participation or within 12 months of ARI-0001 cell infusion, the Principal Investigator must be informed immediately.
- Participants with prior or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
- Specific Inclusion Criteria Before Lymph Depletion
- The following criteria must be confirmed 7 days prior to lymph depletion:
- Confirmation of successful CAR-T cell fabrication.
- No evidence or suspicion of infection.
- Serum creatinine ≤ 2 times the institutional upper limit of normal (ULN) or eGFR >30 mL/min/1.73 m².
- Confirmation of compliance with washout periods.
- No worsening of the patient's clinical status compared to the initial eligibility criteria that, in the opinion of the treating physician, significantly increases the risk due to lymph depletion chemotherapy or excludes them from treatment with the trial CAR-T cell therapy.
- Specific inclusion criteria prior to CAR-T cell infusion.
- Participants must meet the following criteria (Failure to meet these criteria will result in the individual subject's enrollment being halted or suspended entirely at the discretion of the CES and the Principal Investigator):
- No evidence or suspicion of infection.
- Confirmation of compliance with the washout periods.
- No worsening of clinical status compared to the initial eligibility criteria that, in the opinion of the treating physician, significantly increases the risk due to lymphodepleting chemotherapy or excludes them from treatment with the ARI-0001 CAR-T therapy in the trial.
Who cannot join
- 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.
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- 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.
- Known congenital long QT syndrome.
- Left ventricular ejection fraction < 45%.
- Uncontrolled hypertension, defined as ≥ 140/90 mmHg as assessed by the average of three consecutive blood pressure measurements taken over 10 minutes.
- Any other condition that, in the Investigator's judgment, contraindicates the subject's participation in the clinical trial due to safety concerns or issues with compliance with clinical trial procedures (e.g., infection/inflammation, bowel obstruction, inability to swallow medication [subjects cannot receive the medication via a feeding tube], social/psychological problems, etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ACITAC-001: Hybrid Type Two Implementation Study of CAR-T Therapy in Colombia Based on a Pilot Clinical Trial ARI-0001 T Cells With Anti-CD19 Chimeric Antigen Receptor (CAR-T) for the Treatment of Recurrent/Refractory CD19+ Hematolymphoid Neoplasms.
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.
Read more
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.
Read the detailed description
- Collection of autologous T lymphocytes by apheresis Day -4 ± 7
- Transport of cellular material to IDCBIS
- Manufacture of ARI-0001 using CliniMACS Prodigy according to GMP
- Cryopreservation of ARI-0001 cells
- Transport of ARI-0001 cells to the INC
- Temporary storage of ARI-0001 cells at the INC
- Administration of lymphodepletion regimen to patient Days -5, -4, -3
- Thawing of ARI-0001 cell product
- ARI-0001 infusion Days 1, 2, 3
- Outpatient follow-up
- Inpatient monitoring for 14 days
- Collection of samples for paraclinical analysis Days 4-7, 9, 12, 14
- Visit on day 22, biweekly days 22-90, monthly days 91-360
- Conditions
- Adult B-cell Acute Lymphoblastic Leukemia, Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Chronic Lymphocytic Leukemia
- Being tested
- ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T)
- Keywords
- Pilot, Implementation, Safety, ARI-0001, CAR-T, CD19, Lymphoma, Leukemia, Colombia
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 30 days post-infusion.
Secondary outcomes (3)
Overall response rate (ORR)
- Overall response rate (ORR) at 28 and 100 days post-infusion, according to specific diagnostic criteria for each type of CD19+ neoplasm.
Measured: at 28 and 100 days post - infusion
Disease-free survival (DFS)
at 12 and 24 months post-infusion, defined as the time from infusion to progression or death, stratified by type of CD19+ neoplasm.
Measured: at 12 and 24 months post - infusion
Overall survival (OS)
at 12 and 24 months post-infusion, defined as the time from infusion to death.
Measured: at 12 and 24 months post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GUSTAVO SALGUERO
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Cancerologia, Columbia
- Responsible party
- Sponsor-investigator, GUSTAVO SALGUERO, Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS
- Investigators
- Gustavo Salguero, MD PhD MBA, Study director, Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412405
- Sponsor's protocol ID
- ACITAC-001-CART-19-ARI0001
- Other IDs
- ACITAC-001
- Acronym
- ACITAC-001
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACITAC-001: Hybrid Type Two Implementation Study of CAR-T Therapy in Colombia Based on a Pilot Clinical Trial ARI-0001 T Cells With Anti-CD19 Chimeric Antigen Receptor (CAR-T) for the Treatment of Recurrent/Refractory CD19+ Hematolymphoid Neoplasms.
- ClinicalTrials.gov ID
- NCT07412405
- Acronym / sponsor ID
- ACITAC-001 / ACITAC-001-CART-19-ARI0001
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- GUSTAVO SALGUEROUniversity, hospital or other
- Collaborators
- Instituto Nacional de Cancerologia, Columbia
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Collection of autologous T lymphocytes by apheresis Day -4 ± 7
- Transport of cellular material to IDCBIS
- Manufacture of ARI-0001 using CliniMACS Prodigy according to GMP
- Cryopreservation of ARI-0001 cells
- Transport of ARI-0001 cells to the INC
- Temporary storage of ARI-0001 cells at the INC
- Administration of lymphodepletion regimen to patient Days -5, -4, -3
- Thawing of ARI-0001 cell product
- ARI-0001 infusion Days 1, 2, 3
- Outpatient follow-up
- Inpatient monitoring for 14 days
- Collection of samples for paraclinical analysis Days 4-7, 9, 12, 14
- Visit on day 22, biweekly days 22-90, monthly days 91-360
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single-arm, non-randomized pilot clinical trial in patients aged between 18 and 80 years | Experimental | Biological: ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T)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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- 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.
- Inclusion criteria according to the type of CD19+ hematologic malignancy measurable by the 2014 Lugano criteria (NHL) or IWCLL criteria (CLL) or EWALL criteria (ALL).
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T)Pilot clinical trial ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T) treatment of recurrent/refractory CD19+ hematolymphoid neoplasms. | Biological | Single-arm, non-randomized pilot clinical trial in patients aged between 18 and 80 years |
Primary outcome
1. Clinical Safety Outcome (Pilot Cohort)
Time frame: This outcome will be assessed 30 days post-infusion.
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).
2. Clinical Safety Outcome (Pilot Cohort)
Time frame: 12 months after CAR-T cell infusion.
Proportion of patients developing infections within the first 12 months after CAR-T cell infusion.
3. Clinical Safety Outcome (Pilot Cohort)
Time frame: 30 days post-infusion.
Early mortality, defined as death occurring within the first 30 days post-infusion.
3 secondary outcomes
Overall response rate (ORR)
Time frame: at 28 and 100 days post - infusion
Disease-free survival (DFS)
Time frame: at 12 and 24 months post - infusion
Overall survival (OS)
Time frame: at 12 and 24 months post-infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Research centerLink provided by the sponsor.
- Centro de manufacturaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gustavo Salguero, MD PhD MBA study director
Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS
Questions about this trial
What is this clinical trial studying?
A study testing ARI-0001 T cells with anti-CD19 chimeric antigen receptor (CAR-T) in people with Adult B-cell Acute Lymphoblastic Leukemia and Follicular Lymphoma (FL), run by GUSTAVO SALGUERO.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 42 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Wills, MD - IP (+57 601 4817000, bwills@cancer.gov.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Clinical Safety Outcome (Pilot Cohort) (time frame: This outcome will be assessed 30 days post-infusion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.