Relapsed or Refractory B-Cell Acute Lymphoblastic LeukemiaPhase 1COLIBRÍNCT07883941
Phase I Safety Clinical Trial of Anti-CD19 CAR-T Therapy COL01 for the Treatment of Adults With Relapsed or Refractory B-cell Lymphoid Neoplasms: First-in-human Administration, COLIBRI.
A Phase 1 study testing CAR-T anti-CD19 COL01 in people with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia and Lymphoid Malignancies, run by GUSTAVO SALGUERO.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia, Lymphoid Malignancies, Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- CAR-T anti-CD19 COL01
- 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 Apr 2027to 1 May 2030
- Phase
- Phase 1
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Adults aged 18 years or older.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
- Life Expectancy: Expected life expectancy greater than 6 months.
- Informed Consent: Ability to sign the informed consent form.
- Organ Function: Adequate organ function defined as:
- Hematologic: Absolute neutrophil count \>= 1,000/mm³, platelets \>= 50,000/mm³, hemoglobin \>= 8 g/dL.
- Hepatic: Total bilirubin \<= 1.5 times the institutional upper limit of normal (ULN); AST/ALT \<= 2.5 x ULN.
Who cannot join
- Prior Transplant: Autologous or allogeneic stem cell transplant less than 6 weeks prior to CAR-T cell infusion.
- Active Infection: Active infection requiring systemic treatment.
- Autoimmune Disease: History of autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring immunosuppressive, immunomodulatory, or biological treatment, or having received such treatment within the last 6 months.
- Pregnancy / Lactation: Pregnancy or breastfeeding. Females of childbearing potential must have a negative pregnancy test. If breastfeeding is discontinued, the patient will be considered for study participation.
- Concurrent Investigational Agents: Simultaneous treatment with other investigational agents.
- Active Second Malignancy Treatment: Active cancer treatment for a second primary malignancy.
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- Recent Radiotherapy: Radiotherapy within the last 14 days.
- Recent Major Surgery: Major surgery within the last 4 weeks prior to lymphodepletion.
- Prior Malignancies: History of cancer within the last two years prior to screening, except for appropriately locally treated malignancies considered in complete remission with minimal risk of requiring systemic therapy during the study (squamous or basal cell skin cancer, breast carcinoma, bladder carcinoma, cervical carcinoma in situ, low-grade prostate cancer Gleason \<= 6).
- CNS Malignancy: Known brain metastases or epidural disease of origin other than CD19+ malignancy.
- Severe Leukopenia: Leukopenia with white blood cell count \< 1.0 x 10^9/L.
- Bilirubin Thresholds: Total bilirubin \> 2 mg/dL (except in patients with Gilbert's syndrome) or \> 1.5 mg/dL in patients with a history of hepatitis B or C.
- Transaminase Elevation \& Serology: Transaminase elevation \> 5 times the reference value, or \> 3 times in patients with a history of hepatitis B or C. Active or unresolved infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- 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.
- Active Infectious Diseases: Active infections including tuberculosis, active hepatitis B (positive viral load), hepatitis C (positive viral load), or HIV seropositivity.
- Cognitive / Psychiatric Conditions: Medical, psychiatric, or cognitive conditions that compromise the subject's capacity to understand information, make autonomous decisions, sign informed consent, or adhere to protocol requirements.
- Hypersensitivity: History of hypersensitivity reactions to investigational products.
- Treatment Washout Non-compliance: Inability to comply with protocol-stipulated washout periods.
- Relevant CNS Pathologies: History of clinically relevant CNS pathologies (e.g., epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injury, dementia, or Parkinson's disease).
- Unstable CNS Disease: History of CNS
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
GUSTAVO A SALGUERO LÓPEZ, Executive Director of IDCBIS contact
About this study
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:
Read more
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).
Read the detailed description
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.
- Conditions
- Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia, Lymphoid Malignancies, Diffuse Large B Cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma, Relapsed or Refractory B-Cell Lymphoid Malignancies
- Being tested
- CAR-T anti-CD19 COL01
- Keywords
- B-Cell Malignancies, Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Refractory Lymphoma, Relapsed Lymphoma
- Medical subject headings
- Recurrence, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T anti-CD19 COL01Other
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.
| Study group | Role | What they receive |
|---|---|---|
| A single-arm, non-randomized pilot clinical trial in patients over 18 years of age. | Experimental | 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). Receives: Other: CAR-T anti-CD19 COL01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 up to Day 30 post-infusion.
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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.
Measured: Up to 12 months post-infusion.
Overall Survival (OS)
Time from CAR-T cell infusion to death from any cause.
Measured: Up to 12 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 posted20 Oct 2026
- Study start1 Apr 2027 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GUSTAVO SALGUERO
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
- Responsible party
- Sponsor-investigator, GUSTAVO SALGUERO, Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS
- Investigators
- VIRGINIA ABELLO POLO, Internal Medicine - Hematology, Principal investigator, Fundación CTIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883941
- Sponsor's protocol ID
- IDCBIS-INV-UTA-PEC-002
- Acronym
- COLIBRÍ
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decision has been made on the matter yet.
Publications
Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. doi: 10.1056/NEJMoa1707447. Epub 2017 Dec 10.
PubMed 29226797Wang J, Bisson PJ, Marmolejos JM, Shultz MJ. Nonlinear interferometer: Design, implementation, and phase-sensitive sum frequency measurement. J Chem Phys. 2017 Aug 14;147(6):064201. doi: 10.1063/1.4997736.
PubMed 28810790Martyniak K, Wei F, Ballesteros A, Meckmongkol T, Calder A, Gilbertson T, Orlovskaya N, Coathup MJ. Do polyunsaturated fatty acids protect against bone loss in our aging and osteoporotic population? Bone. 2021 Feb;143:115736. doi: 10.1016/j.bone.2020.115736. Epub 2020 Nov 7.
PubMed 33171312Zhang M, Cui Y, Liu YH, Xu W, Sze SH, Murray SC, Xu S, Zhang HB. Accurate prediction of maize grain yield using its contributing genes for gene-based breeding. Genomics. 2020 Jan;112(1):225-236. doi: 10.1016/j.ygeno.2019.02.001. Epub 2019 Feb 28.
PubMed 30826444