Trial · NCT05260957
CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).
NCT05260957, Phase 2, Recruiting, Lazaros Lekakis
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL). Trials, record NCT05260957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05260957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).
- NCT number
- NCT05260957
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 22 participants, estimated
- Lead sponsor
- Lazaros Lekakis
- Conditions
- Refractory Non-Hodgkin Lymphoma, Relapsed Non Hodgkin Lymphoma, Aggressive Non-Hodgkin Lymphoma
- Interventions
- Mosunetuzumab, Polatuzumab, CAR-T Cell Therapy
- First posted
- 2022-03-02
- Last updated
- 2025-12-31
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate | 3 Months | Complete Response (CR) rate will be reported as the percentage of participants achieving complete response (CR) to study treatment. Response to therapy will be assessed using Positron Emission Tomography (PET)/ Computerized Tomography (CT) scan following Lugano 2014 criteria (Cheson et al, Journal of Clinical Oncology (JCO), 2014) at 3 months (Day +90) of study treatment. For equivocal PET-CT results, biopsy will be performed after day +90 PET/CT to assess true CR or persistent lymphoma. |
| Secondary | Overall Response Rate (ORR) | Up to 3 months | Overall response rate (ORR) will be reported as the percentage of participants achieving either complete response (CR) or partial response (ORR = CR + PR) to study treatment. Response to therapy will be assessed using Positron Emission Tomography (PET)/ Computerized Tomography (CT) scan following Lugano 2014 criteria (Cheson et al, Journal of Clinical Oncology (JCO), 2014) up to Day +90 of study treatment. |
| Secondary | Progression free survival (PFS) Rate | Up to 2 years | PFS is defined as the elapsed time from the date of starting treatment to the date of progression, or date of death from any cause; whichever comes first. PFS rate will be reported as the percentage of participants without progressive disease after start of treatment. |
| Secondary | Overall Survival (OS) Rate | Up to 2 years | Overall survival is defined as the elapsed time from the date of starting treatment to the date of death from any cause. OS rate will be reported as the percentage of participants still alive after start of treatment. |
| Secondary | Minimal residual disease (MRD) negativity | Up to 1 year | Minimal residual disease (MRD) negativity will be reported as the percentage of participants showing absence of measurable disease in peripheral blood after start of CAR-T Cell therapy. MRD negativity will be assessed by using the Clustering and Alignment of Polymorphic Sequences (CAPSeq) assay. |
| Secondary | Duration of Response (DoR) | Up to 2 years | Duration of response is defined as the elapsed time from date of complete response (CR) to the date of progression or death, whichever is first. DoR will be reported as the percentage of participants who relapsed after achieving CR on the Day +90 PET/CT scan. Relapse rate applies to unequivocal metabolic relapse or/and biopsy confirmed relapse among the patients who achieved CR on day +90 PET-CT |
| Secondary | Toxicity Rate of CAR-T Cell Therapy: ICANS Events | Up to 6 months | Toxicity rate of CAR-T Cell Therapy will be reported as the percentage of participants with treatment-emergent Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS), after start of therapy, as evaluated by treating physician. The severity of ICANS events in participants will be assessed using American Society for Transplantation and Cellular Therapy (ASTCT) Consensus grading criteria (Lee et al, Biol Blood Marrow Transplant., 2019). |
| Secondary | Toxicity Rate of CAR-T Cell Therapy: CRS Events | Up to 6 months | Toxicity rate of CAR-T Cell Therapy will be reported as the percentage of participants with treatment-emergent Cytokine Release Syndrome (CRS) events, after start of therapy, as evaluated by treating physician. The severity of CRS events in participants will be assessed using American Society for Transplantation and Cellular Therapy (ASTCT) Consensus grading criteria (Lee et al, Biol Blood Marrow Transplant., 2019). |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05260957
GET https://conductscience.org/api/trials/v1/NCT05260957/registered