Colombia-Made CAR-T cells put to the test against stubborn blood cancers
NCT ID NCT07883941
First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time
Summary
Researchers are running a first-in-human Phase I trial of COL01, an experimental CAR-T cell therapy that targets the CD19 marker on B cells. The study enrolls adults with relapsed or refractory B-cell cancers, including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, and B-cell acute lymphoblastic leukemia, after at least two prior treatments. Participants give blood cells through leukapheresis so the therapy can be manufactured from their own T cells, receive conditioning chemotherapy, and then get a single infusion of the modified cells. The main goals are to measure safety, side effects such as cytokine release syndrome and neurotoxicity, and to find the highest dose people can tolerate for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental anti-CD19 CAR-T cell therapy called COL01, made from a patient's own modified T cells
- What this could lead to
- If it works, this could offer a locally produced CAR-T option for people whose B-cell cancers have come back after standard treatment.
- What could go wrong
- This is a very small first-in-human safety trial, so researchers do not yet know the right dose or how well it works. CAR-T therapy can cause serious immune reactions and neurological side effects that require close monitoring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2027
An estimate. Start dates often move.
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Age: Adults aged 18 years or older. 2. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status \\\<= 2. 3. Life Expectancy: Expected life expectancy greater than 6 months. 4. Informed Consent: Ability to sign the informed consent form. 5. Organ Function: Adequate organ function defined as: 1. Hematologic: Absolute neutrophil count \\\>= 1,000/mm³, platelets \\\>= 50,000/mm³, hemoglobin \\\>= 8 g/dL. 2. Hepatic: Total bilirubin \\\<= 1.5 times the institutional upper limit of normal (ULN); AST/ALT \\\<= 2.5 x ULN. Exclusion Criteria 1. Prior Transplant: Autologous or allogeneic stem cell transplant less than 6 weeks prior to CAR-T cell infusion. 2. Active Infection: Active infection requiring systemic treatment. 3. 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. 4. 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. 5. Concurrent Investigational Agents: Simultaneous treatment with other investigational agents. 6. Active Second Malignancy Treatment: Active cancer treatment for a second primary malignancy. 7. Recent Radiotherapy: Radiotherapy within the last 14 days. 8. Recent Major Surgery: Major surgery within the last 4 weeks prior to lymphodepletion. 9. 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). 10. CNS Malignancy: Known brain metastases or epidural disease of origin other than CD19+ malignancy. 11. Severe Leukopenia: Leukopenia with white blood cell count \\\< 1.0 x 10\^9/L. 12. 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. 13. 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). 14. 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. 15. Active Infectious Diseases: Active infections including tuberculosis, active hepatitis B (positive viral load), hepatitis C (positive viral load), or HIV seropositivity. 16. 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. 17. Hypersensitivity: History of hypersensitivity reactions to investigational products. 18. Treatment Washout Non-compliance: Inability to comply with protocol-stipulated washout periods. 19. 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). 20. \*\*Unstable CNS Disease:\*\* History of CNS
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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