Trial · NCT07883941
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.
NCT07883941, Phase 1, Not yet recruiting, GUSTAVO SALGUERO
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07883941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07883941
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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.
- NCT number
- NCT07883941
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 12 participants, estimated
- Lead sponsor
- GUSTAVO SALGUERO
- 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
- Interventions
- CAR-T anti-CD19 COL01
- First posted
- 2026-10-20
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), Cytokine Release Syndrome (CRS), and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) | From Day 0 (infusion) up to Day 365 post-infusion. | 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. |
| Primary | Incidence of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), and Recommended Phase 2 Dose (RP2D) | Day 0 up to Day 30 post-infusion. | 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. |
| Secondary | Overall Response Rate (ORR) | Evaluated at Month 1, Month 3, Month 6, and Month 12 post-infusion. | 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). |
| Secondary | Cellular Expansion and Persistence of CAR-T anti-CD19 COL01 | Baseline (pre-infusion), Days +7, +14, +28, Month 3, Month 6, and Month 12 post-infusion. | 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). |
| Secondary | Progression-Free Survival (PFS) | Up to 12 months post-infusion. | Time from CAR-T cell infusion to disease progression, relapse, or death from any cause. |
| Secondary | Overall Survival (OS) | Up to 12 months post-infusion. | Time from CAR-T cell infusion to death from any cause. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07883941
GET https://conductscience.org/api/trials/v1/NCT07883941/registered