Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy

NCT06552572 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MO44989
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to determine whether the CD20-CD3 bispecific antibody, glofitamab, is effective in treating residual diffuse large B-cell lymphoma (DLBCL) in adults who have responded to CD19 Chimeric antigen receptor (CAR) T-cell therapy for their relapsed or refractory DLBCL. Additionally, the trial will assess the safety of glofitamab in patients undergoing CD19 CAR T-cell therapy. The primary questions to be addressed are: Does glofitamab reduce the number of participants experiencing disease progression following CD19 CAR T-cell therapy? What are the medical complications in participants already treated with CD19 CAR T-cell therapy when administered glofitamab? Participants are required to: Receive glofitamab every 21 days for 12 cycles or until disease progression. Attend the clinic for checkups and tests every three weeks.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse large B-cell lymphoma; Glofitamab; CD19 CAR T-cell

Outcome Measures

Primary Outcomes (1)

• 1-year progression free survival rate after enrollment

  Measurement of progression-free survival after CD19 CAR T-cell therapy

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years

Study Arms (1)

Glofitamab

EXPERIMENTAL

Glofitamab every 21 days for 12 cycles or until progression. 1. First cycle * Obinutuzumab (GPT) 1000mg (D1) * Glofitamab step up dosing 2.5mg (D8) → 10mg (D15) 2. After the first cycle (completed priming): 30mg IV every 3 weeks.

Drug: Glofitamab

Interventions

Glofitamab DRUG

Glofitamab is administered to patients who have residual disease after CD19 CAR T-cell therapy for their relapsed or refractory diffuse large B-cell lymphoma

Also known as: Columvi® (Roche)

Glofitamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Age ≥ 18 years at the time of signing the informed consent form.
• Histologically diagnosed diffuse large B-cell lymphoma, NOS initially, as defined by 2016 WHO guidelines and confirmed relapsed and refractory disease, defined as follows.
• Relapsed: the disease that has recurred following a response that lasted over 6 months after completing the last line of therapy.
• Refractory: the disease that did not respond to or that progressed less than 6 months after completion of the last line of therapy
• RR-DLBCL patients who should undergo CD 19 CAR-T cell treatment prior to recruitment of this study have achieved partial response (PR) at one or three months after CAR-T cell infusion (If the patient achieves PR at one or three months, patients have to enroll within at least 3 months after CAR-T cell infusion.)
• ECOG PS: 0-2
• Adequate hematologic function, as defined by the following laboratory values (If cytopenia is associated with bone marrow involvement, the subject is excluded):
• Absolute neutrophil \> 1,000/mm3
• Hemoglobin \> 9.0 g/dL (Transfusion free within 21 days prior to administration of glofitamab)
• Platelet \> 75,000/mm3 (Transfusion free within 21 days prior to administration of glofitamab)
• If the patient does not recover neutropenia at one month even though achieving PR, the investigator could wait until 3 months from first achieving PR at one month. However, the patient has to remain in PR status.
• Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
• Adequate organ function, as defined by the following laboratory values
• AST, ALT \< 3.0x upper limit of normal (ULN).

You may not qualify if:

• Patients have failed to respond to CD19 CAR-T cell therapy.
• Patients who received previously treated bispecific antibodies.
• Current or past history of primary or secondary central nervous system (CNS) lymphoma.
• Peripheral neuropathy was assessed to be grade \>1 according to NCI CTCAE v5.0 at enrollment.
• Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
• \- Patients with a history of stroke who have not experienced a stroke of transient ischemic attack within the past 2 years and have no residual neurologic deficits, as judged by the investigator, are allowed.
• Any of the following abnormal laboratory values, unless abnormal laboratory values are associated with the underlying lymphoma per the investigator. (Patients with a documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible if the total bilirubin is ≤ 3 × ULN)
• AST/ ALT ≥ 3.0 X upper limit of normal (ULN).
• Total bilirubin ≥ 1.5 X ULN.
• Has a concomitant malignancy or had a malignancy (except for appropriately treated basal or squamous cell carcinoma or cervical carcinoma in situ) in the last 3 years prior to initiation of the study treatment
• Underwent a major surgery within 21 days prior to initiating the study treatment or has not recovered from severe side effects of surgery
• Concomitant use of immunosuppressants, except for the following:
• \- Intranasal, inhaled, or topical steroid, or local steroid injection (such as intra-articular injection)
• Physiological dose ≤ 10 mg/day of prednisone or equivalent doses of systemic corticosteroid
• Premedication with steroids to prevent hypersensitivity reaction (such as premedication prior to a CT scan). At the discretion of the investigator, the use of prednisolone at ≥10 mg for adrenal insufficiency may be acceptable.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

glofitamab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Seok Jin Kim, MD., PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients with relapsed or refractory diffuse large B-cell lymphoma who respond to CD19 CAR T-cell therapy: Partial response at one or three months after CAR T-cell therapy

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 14, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)