Trial · NCT07003295
Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy
NCT07003295, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy. Trials, record NCT07003295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07003295
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy
- NCT number
- NCT07003295
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
- Interventions
- Biospecimen Collection, Computed Tomography, Glofitamab, Obinutuzumab, Positron Emission Tomography
- First posted
- 2025-06-04
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate | Up to 2 years | A Simon 2-stage optimal design will be used with a favorable response of 55% and unfavorable response of 25%. |
| Secondary | Complete response rate | Up to 2 years | Proportions will be estimated with Agresti-Coull 95% binomial confidence intervals. |
| Secondary | Progression-free survival (PFS) | Up to 24 months | Proportions will be estimated with Agresti-Coull 95% binomial confidence intervals. Will be estimated using the Kaplan Meier method. Estimates of PFS will be reported with a 95% confidence interval. |
| Secondary | Overall survival (OS) | Up to 24 months | Proportions will be estimated with Agresti-Coull 95% binomial confidence intervals. Will be estimated using the Kaplan Meier method. Estimates of OS will be reported with a 95% confidence interval. |
| Secondary | Incidence of grade 3-4 cytokine release syndrome | Up to 2 years | Proportions will be estimated with Agresti-Coull 95% binomial confidence intervals. Incidence will be described. |
| Secondary | Incidence of grade 3-4 neurologic toxicity | Up to 2 years | Proportions will be estimated with Agresti-Coull 95% binomial confidence intervals. Incidence will be described. |
| Secondary | Changes in glofitamab clearance | At baseline and up to 2 years | Pharmacokinetics (PK) of glofitamab will also be determined to assess exposure-response and clearance-response relationships. When appropriate, Bayesian logistic regression analysis will be performed to assess exposure-response and clearance-response relationships. Basic non-compartmental analyses will be performed with the concentration versus time data to summarize several pharmacokinetic parameters including observed maximum concentration and area under the observed concentration versus time curves. Descriptive statistics will be used to summarize these results. Nonlinear mixed-effects modeling will also be performed to develop a population PK model of glofitamab to describe PK properties, including absorption, distribution, and overall elimination. |
| Other | Relationship in circulating tumor deoxyribonucleic acid (ctDNA) in plasma, treatment response, and duration of response | On day 1 of cycles 1, 3, and 5 (cycle length = 21 days) | Descriptive statistics will be used to summarize the ctDNA results. |
| Other | Relationship between chimeric antigen receptor (CAR) T-cell levels in plasma, immunophenotype, treatment response, and duration of response | On day 1 of cycles 1, 3 and 5 (cycle length = 21 days) | Descriptive statistics will be used to summarize the CAR-T and T-cell immunophenotype results. |
| Other | Glofitamab PK | Before and 5-60 minutes after glofitamab infusions on day 8 of cycle 1 and day 1 of cycles 2-4, 6, 9, and 12 (cycle length = 21 days) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186691 | The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies | CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
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/NCT07003295
GET https://conductscience.org/api/trials/v1/NCT07003295/registered