A Phase 1 interventional study of CAR-T anti-CD19 COL01 in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia, Lymphoid Malignancies and Diffuse Large B Cell Lymphoma (DLBCL), sponsored by GUSTAVO SALGUERO. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by GUSTAVO SALGUERO · Phase 1, Interventional, and Treatment
The objective of this Phase I clinical trial is to evaluate the safety, toxicity profile, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of autologous CAR-T anti-CD19 cell therapy (CAR-T ANTI-CD19 COL01) in adult participants (aged 18 years and older) with relapsed or refractory CD19-positive B-cell lymphoid malignancies (including diffuse large B-cell lymphoma [DLBCL], mantle cell lymphoma [MCL], follicular lymphoma [FL], and precursor B-cell acute lymphoblastic leukemia [B-ALL]) after at least two prior lines of systemic treatment.
The primary questions this study aims to answer are:
What is the safety and toxicity profile, including the incidence and severity of adverse events (such as Cytokine Release Syndrome [CRS], Immune Effector Cell-Associated Neurotoxicity Syndrome [ICANS]), and dose-limiting toxicities (DLTs) associated with CAR-T ANTI-CD19 COL01?
What is the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CAR-T ANTI-CD19 COL01 for future clinical studies?
Comparison Group:
This is a single-arm, non-comparative Phase I study; there is no comparison or control group. All enrolled participants receive the investigational CAR-T ANTI-CD19 COL01 therapy.
Participants will be asked to:
Undergo screening procedures and baseline diagnostic assessments to determine eligibility.
Undergo leukapheresis for peripheral blood T-cell collection to manufacture the autologous CAR-T cell product.
Receive a lymphodepleting conditioning chemotherapy regimen prior to product administration.
Receive a single intravenous infusion of CAR-T ANTI-CD19 COL01 cells. Complete mandatory post-infusion monitoring (inpatient and outpatient surveillance), safety checks, blood sampling, and clinical disease response evaluations (including imaging and/or bone marrow examinations).
Background and Study Rationale
Relapsed or refractory (R/R) CD19-positive B-cell malignancies-including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and precursor B-cell acute lymphoblastic leukemia (B-ALL)-represent a critical unmet medical need in Colombia. Commercial CAR-T therapies face severe financial and logistical access barriers in resource-limited healthcare settings. The COLIBRÍ trial evaluates the feasibility, safety, and preliminary biological activity of locally manufactured autologous CAR-T anti-CD19 COL01 cells produced by the District Institute of Science, Biotechnology, and Health Innovation (IDCBIS) as an Advanced Therapy Medicinal Product (ATMP).
Investigational Product and Manufacturing
CAR-T anti-CD19 COL01 consists of autologous CD4+ and CD8+ T lymphocytes genetically modified using a lentiviral vector to express a second-generation chimeric antigen receptor (CAR) targeting the CD19 cell surface antigen. Centralized biomanufacturing, viral transduction, and cellular expansion are performed in a closed, automated system (CliniMACS Prodigy®) under Good Manufacturing Practices (GMP) at the IDCBIS Advanced Therapies Unit in Bogotá, Colombia.
Study Design and Sequential Dose Escalation
This is an open-label, single-center, single-arm, Phase I study enrolling a total of 12 adult participants. The protocol employs a sequential dose-escalation design across three dose cohorts (n = 3 per cohort) to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D), based on Dose-Limiting Toxicity (DLT) evaluations during the first 30 days post-infusion:
Cohort 1 (Low Dose): Initial evaluation of safety and tolerability. Cohort 2 (Medium Dose): Dose escalation following independent safety clearance of Cohort 1.
Cohort 3 (High Dose): Dose escalation contingent upon favorable safety in Cohort 2.
Expansion Cohort (n = 3): Optimization cohort treated at the selected RP2D to further characterize biological activity, cellular kinetics, and safety profiles.
Clinical Workflow and Patient Care Continuum
The clinical sequence is conducted at the Cancer Treatment and Research Center (CTIC) and involves five key operational stages:
Screening and Selection: Multidisciplinary medical board review and baseline clinical assessments.
Leukapheresis and Manufacturing: Autologous peripheral blood T-cell collection followed by centralized GMP processing, quality control testing, and cryopreservation.
Lymphodepletion: A standardized conditioning chemotherapy regimen (Fludarabine and Cyclophosphamide) administered on Days -5 to -3 prior to infusion to optimize CAR-T engraftment.
Administration and Acute Surveillance: Single intravenous administration of CAR-T anti-CD19 COL01 cells on Day 0, followed by mandatory inpatient monitoring (Days +1 to +8) for acute toxicities, including Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
Long-term Follow-up: Outpatient safety and efficacy follow-up visits up to Day +365, including immune reconstitution, cellular persistence tracking (flow cytometry and qPCR), and disease response evaluations.
4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.
This study's planned enrollment of 12 is below the median of 50 across 3,429 interventional studies indexed under Recurrence.
Browse Recurrence studies →GUSTAVO SALGUERO is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Organ Function: Adequate organ function defined as:
Exclusion Criteria
Uncontrolled Intercurrent Illness: Evidence of uncontrolled intercurrent illness, including but not limited to:
Active Cardiovascular Disease: Class III or IV congestive heart failure according to NYHA; unstable angina pectoris; severe cardiac arrhythmias.
Ischemic/Thromboembolic Events: Stroke (including transient ischemic attack , myocardial infarction, or thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) within 3 months prior to the first dose.
ECG/Cardiac Parameters: QTc interval prolongation defined as QTcF \> 500 ms; known congenital long QT syndrome; Left Ventricular Ejection Fraction (LVEF) \\< 45%.
Hypertension: Uncontrolled arterial hypertension (\>= 140/90 mmHg average of 3 measurements over 10 minutes despite \>= 2 antihypertensive drugs).
Metabolic / Renal: Poorly controlled diabetes mellitus despite adequate therapy; acute kidney disease requiring dialysis.
Other Safety Contraindications: Any condition that, in the principal investigator's judgment, contraindicates participation due to safety or protocol compliance concerns.
This is an open-label, single-center, non-randomized, single-arm, Phase I dose-escalation clinical trial employing a single group assignment design. The study uses a sequential cohort dose-escalation scheme (3 cohorts of 3 participants each) to evaluate safety and toxicity, and to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of autologous CAR-T ANTI-CD19 COL01 cells. Each participant receives a single intravenous infusion following standardized lymphodepleting conditioning chemotherapy. Safety and Dose-Limiting Toxicities (DLTs) are monitored during a mandatory 30-day post-infusion observation period before advancing to the next dose level. Following the identification of the MTD/RP2D, an expansion cohort of 3 additional participants will be treated at the RP2D to further characterize safety, cellular expansion, and persistence kinetics (total target sample size: N = 12).
Other: CAR-T anti-CD19 COL01
Anti-CD19 CAR-T COL01 is an autologous cell therapy product composed of human peripheral blood T lymphocytes, genetically modified using a second-generation lentiviral vector to express a chimeric antigen receptor (CAR) targeting the CD19 cell-surface molecule. Key features of this intervention include: * Produced locally in Bogotá, Colombia, at the Advanced Therapies Unit of the District Institute of Science, Biotechnology, and Innovation in Health (IDCBIS). * Manufacturing, lentiviral transduction, and cell expansion are performed using the automated closed-system CliniMACS Prodigy® platform, under Good Manufacturing Practice (GMP) conditions. * Specifically designated under protocol IDCBIS-INV-UTA-PEC-002 (COLIBRÍ trial). * Administration regimen: Administered as a single intravenous dose following standardized lymphodepleting chemotherapy (fludarabine/cyclophosphamide), across three defined sequential dose-escalation cohorts.
Incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), Cytokine Release Syndrome (CRS), and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Safety profile evaluation of CAR-T anti-CD19 COL01. Adverse events and lab toxicities graded according to NCI CTCAE v5.0. CRS graded according to ASTCT consensus criteria; ICANS graded according to ASTCT consensus criteria.
Time frame: From Day 0 (infusion) up to Day 365 post-infusion.
Incidence of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), and Recommended Phase 2 Dose (RP2D)
Evaluation of protocol-defined DLTs occurring during the acute post-infusion observation window to identify the MTD and select the RP2D across dose-escalation cohorts.
Time frame: Day 0 up to Day 30 post-infusion.
Overall Response Rate (ORR)
Proportion of participants achieving Complete Response (CR) or Partial Response (PR) determined by standard disease-specific response criteria (e.g., Lugano 2014 criteria for malignant lymphomas and NCCN/IMWG guidelines where applicable).
Time frame: Evaluated at Month 1, Month 3, Month 6, and Month 12 post-infusion.
Cellular Expansion and Persistence of CAR-T anti-CD19 COL01
Quantitative measurement of CAR-T anti-CD19 COL01 cellular expansion -including peak expansion, time to peak expansion , and long-term persistence in peripheral blood measured by flow cytometry and/or quantitative polymerase chain reaction (qPCR).
Time frame: Baseline (pre-infusion), Days +7, +14, +28, Month 3, Month 6, and Month 12 post-infusion.
Progression-Free Survival (PFS)
Time from CAR-T cell infusion to disease progression, relapse, or death from any cause.
Time frame: Up to 12 months post-infusion.
Overall Survival (OS)
Time from CAR-T cell infusion to death from any cause.
Time frame: Up to 12 months post-infusion.
No study locations are listed for this record.
Plan to share: Undecided — No decision has been made on the matter yet.
Start is estimated for Apr 2027; primary completion for Oct 2029, 30 months later.
Of 256 non-industry phase 1 interventional studies under Recurrence, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 77. This study's planned 30 months is below that.
Counting every sponsor, half of 400 studies reached it within 54 months; a quarter within 32 and three quarters within 77.
Recurrence covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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GUSTAVO SALGUERO