Colombia-Made CAR-T cells put to the test against stubborn blood cancers

NCT ID NCT07883941

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2027

An estimate. Start dates often move.

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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