Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT07003295 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT07003295: Recruiting Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by National Cancer Institute (NCI).

NCT07003295 is a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants, below the 37-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT07003295, a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.

Primary Outcome

A Simon 2-stage optimal design will be used with a favorable response of 55% and unfavorable response of 25%.

Conditions Studied

Recurrent Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Positron Emission Tomography
  • BIOLOGICAL Obinutuzumab
  • BIOLOGICAL Glofitamab

Study Locations (1)

Maryland

  • JHU Sidney Kimmel Comprehensive Cancer Center LAO - Baltimore

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2026-08-14
Est. Completion 2027-08-31
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT07003295 shows while recruiting

NCT07003295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 37-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (46% lower).

The record links to 2 conditions, with Recurrent Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT07003295 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT07003295 about?

NCT07003295 is a clinical study titled "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". This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-dir...

What is the current status of trial NCT07003295?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-08-14. Estimated completion is 2027-08-31.

What conditions does trial NCT07003295 study?

This clinical trial studies the following conditions: Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma.

What interventions are being tested in trial NCT07003295?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Obinutuzumab (BIOLOGICAL), Glofitamab (BIOLOGICAL).

Who is sponsoring clinical trial NCT07003295?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07003295 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent Mantle Cell Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07003295's enrollment target sits among peer trials

20 21st of 27 higher than 6 of 27 other Recurrent Mantle Cell Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Mantle Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00573339 · 20 participants

    Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing

  • NCT00692939 · 20 participants · Phase 1

    Autologous Stem Cell Transplantation for Crohn's Disease

  • NCT00967785 · 20 participants · Phase 1

    A Phase I Study of Mozobil in the Treatment of Patients With WHIMS

  • NCT01406691 · 20 participants · Phase 4

    Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT07003295

Source: ClinicalTrials.gov NCT07003295, the US trial registry maintained by the National Library of Medicine. NCT07003295 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.