Glofitamab plus drug combination for relapsed/refractory large B‑cell lymphoma in high‑risk second‑line patients eligible for CAR‑T therapy

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What is this study about?

Patients with relapsed/refractory Large B-Cell Lymphoma have disease that has come back or does not respond to standard treatments, making it harder to achieve lasting control. The trial investigates a treatment plan that first uses the medication glofitamab together with two chemotherapy drugs, gemcitabine and oxaliplatin, followed by a form of personalized immunotherapy called CAR‑T cell therapy. After the CAR‑T cells are given, additional doses of glofitamab are used to try to keep the cancer in check.

The purpose of the study is to see if this step‑by‑step approach can improve outcomes for people with this high‑risk lymphoma. Participants will receive the initial combination of glofitamab plus chemotherapy in several treatment cycles, then undergo infusion of a CAR‑T product such as Breyanzi or Yescarta, and finally receive further glofitamab doses as consolidation. The whole sequence takes place over several months, with regular clinic visits for infusions, monitoring, and safety checks.

Throughout the trial, doctors will watch for any side effects, assess how well the disease responds, and evaluate overall health and quality of life. Follow‑up continues after the last treatment to see how long the response lasts and to track any late‑appearing effects.

1 start induction therapy

receive glofitamab (columvi) as an intravenous infusion at a dose of 30 mg. the medication is delivered through a vein using a drip pump.

together with glofitamab, gemcitabine and oxaliplatin (standard chemotherapy drugs) are given. the exact amounts and how often they are administered are defined by the study protocol.

the induction period continues until the scheduled response assessment is completed.

2 response assessment after induction

clinical examinations, laboratory tests and imaging scans are performed to evaluate how the disease has responded to the induction treatment.

the results determine whether the patient will proceed to the next phase of therapy.

3 receive car‑t cell therapy

a single infusion of a genetically modified immune‑cell product is administered intravenously.

two possible products may be used:

• lisocabtagene maraleucel (breyanzi) at a dose of 120 000 000 cells.

• axicabtagene ciloleucel (yescarta) at a dose of 2 000 000 cells.

the chosen product is infused through a vein; the exact procedure follows the study protocol.

4 start consolidation therapy

after recovery from the car‑t cell infusion, glofitamab monotherapy is given as an intravenous infusion at a dose of 30 mg.

the medication is administered according to the schedule defined in the protocol (for example, every few weeks).

consolidation continues until the end‑of‑treatment visit.

5 follow‑up visits and evaluations

regular visits are scheduled to monitor safety and effectiveness. assessments include physical examinations, blood tests, and imaging studies.

key time points include the visit three months after the car‑t cell infusion, as well as later visits up to two years from the start of treatment.

quality‑of‑life questionnaires may be completed during these visits.

Who Can Join the Study?

Written informed consent: you must sign a document showing you understand the study and agree to take part.
Successful MNC-leucapheresis (a procedure that collects your immune cells to make a CAR‑T‑cell therapy) for a commercially available CAR‑T‑cell product.
Willing and able to provide a baseline biopsy (a small sample of tumor tissue, either from old records or a fresh sample) for central review.
If you are a male with a female partner who could become pregnant, you must agree to use contraception for the entire study period and for a set time after the study drugs (the longest required time).
If you are a female who could become pregnant, you must agree to use a highly effective method of contraception (such as hormonal birth control, an intrauterine device, or surgical sterilization) for the entire study period and for a set time after the study drugs (the longest required time).
Age between 18 and 80 years at the time you sign the consent form.
Confirmed diagnosis of large B‑cell lymphoma by a local pathologist at the time your disease returns or does not improve.
You have received first‑line treatment called R‑CHOP (a chemotherapy regimen that includes a CD20‑targeting antibody and anthracycline drugs).
Your disease must be relapsed or refractory:
- Relapsed: cancer came back within 12 months after a partial or complete response.
- Refractory: cancer never responded or got worse less than 6 months after the first‑line therapy.
You have at least one tumor spot that shows up on an FDG‑PET scan (a type of imaging) and is at least 1.5 cm in two dimensions if it is in a lymph node, or a spot outside a lymph node that is larger than 1 cm on a CT scan.
Your ECOG performance status (a measure of how well you can carry out daily activities) must be between 0 and 2.
Your absolute lymphocyte count (a type of white blood cell) must be greater than 200 per microliter of blood.
You must be considered eligible for CAR‑T‑cell therapy by the investigator and have adequate organ function, meaning:
- Kidney: estimated glomerular filtration rate (eGFR) ≥ 60 mL/min.
- Liver: ALT and AST enzymes ≤ 5 times the normal upper limit, and bilirubin ≤ 2.0 mg/dL (unless you have a specific liver condition).
- Bone marrow: absolute neutrophil count ≥ 1,000/µL, platelets ≥ 50,000/µL, and hemoglobin > 8.0 g/dL.
- Heart: ejection fraction (a measure of heart pumping) ≥ 45%.
- Lungs: pulmonary function judged adequate by the investigator.

Who Cannot Join the Study?

HIV infection of any stage, meaning you have a positive HIV test (antibodies or RNA) during the screening.
Current or past disease of the brain or spinal cord, such as stroke, epilepsy, blood‑vessel inflammation in the brain, or a neurodegenerative disorder.
Significant heart problems, including severe heart failure (class III or IV), a heart attack in the last three months, unstable irregular heart rhythms, or unstable chest pain (angina).
An active autoimmune disease that needs treatment that affects the whole body (systemic treatment).
Regular use of high‑dose steroids (more than 20 mg of prednisone or an equivalent each day). Low‑dose steroids (20 mg or less) taken steadily for at least a week, or short courses of higher doses finished before the first study drug, are allowed.
Women who are pregnant, breastfeeding, or who plan to become pregnant within 18 months after starting the study, and women who could become pregnant must have a negative pregnancy test within three days before treatment.
A personal relationship of dependence or an employer‑employee relationship with the study sponsor or investigator.
Inability to understand the trial, its risks, and benefits, or to make decisions about participation.
Non‑compliance issues, such as heavy alcohol use, drug or substance abuse that would interfere with study requirements, refusal to receive blood products, or any situation that would make the treatment or follow‑up impossible.
Previous or current other cancers, except for a cancer that was cured by surgery and was carcinoma in‑situ, or other cancers that have been disease‑free for at least three years.
Known severe allergy to any part of the study drugs (Glofitamab, Obinutuzumab, Yescarta®, Breyanzi®), or a history of serious allergic reactions (including anaphylaxis) to similar antibody medicines.
Severe active infection that needed IV antibiotics or antiviral medication within 14 days before the first dose of study drugs.
Congenital (present at birth) or acquired (developed later) immune system problems, including having had an organ transplant or a stem‑cell transplant from another person.
Previous treatment with Glofitamab or other “bispecific” antibodies that target both CD20 and CD3 proteins on cells.
Previous use of the chemotherapy drugs gemcitabine and oxaliplatin in earlier lymphoma treatment.
Major surgery performed within four weeks before the first dose of study drugs.
Having primary (originating in the brain/spinal cord) or secondary (spread to the brain/spinal cord) central nervous system lymphoma at the time of enrollment, or a past history of CNS lymphoma.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Ufjsajhqknenemnodqvzh Dwtchpirapd Avs	Duesseldorf	Germany
Uktgnlkplvwvbvhribvel Mtdhbrql Afx	Munster	Germany
Umsgupddpsrrgptshoaxe Ecxbv Afz	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	15.04.2026

Trial locations

Investigated drugs:

Glofitamab is a laboratory-made antibody that helps the immune system recognize and attack large B‑cell lymphoma cells. In this study it is given first together with chemotherapy to shrink the cancer, and later it is used alone to try to keep the disease from coming back after the patients receive CAR‑T cell therapy.

Gemcitabine is a chemotherapy drug that interferes with the DNA of cancer cells, making it harder for them to grow and divide. In the trial it is combined with oxaliplatin and given together with glofitamab as an initial “induction” treatment to reduce the tumor burden before the CAR‑T cell therapy.

Oxaliplatin is another chemotherapy medication that damages the DNA inside cancer cells, helping to stop their growth. It is used alongside gemcitabine and glofitamab in the early part of the treatment plan to make the lymphoma more responsive to later therapies.

Obinutuzumab is a targeted antibody that binds to a protein (CD20) found on the surface of many B‑cell lymphomas. By attaching to this protein, it marks the cancer cells for destruction by the immune system and can also directly trigger cell death. It is given as part of the study to help control the disease before or after the CAR‑T cell therapy.

Lisocabtagene maraleucel is a type of CAR‑T cell therapy. Doctors take a patient’s own T‑cells, modify them in a lab to recognize lymphoma cells, grow many of them, and then infuse them back into the patient. These engineered cells can seek out and kill cancer cells throughout the body. In the trial it is offered as the standard CAR‑T treatment option for eligible patients.

Axicabtagene ciloleucel is another CAR‑T cell therapy that works in the same way as lisocabtagene maraleucel: a patient’s T‑cells are collected, genetically altered to target lymphoma cells, expanded, and returned to the patient to attack the cancer. It is also used as a standard CAR‑T option for participants in the study.

Investigated diseases:

Diffuse large B-cell lymphoma recurrent

relapsed/refractory Large B-Cell Lymphoma – Relapsed/refractory Large B-Cell Lymphoma is a type of blood cancer that originates from large B lymphocytes, a kind of white blood cell. It initially develops as a mass of abnormal cells in lymph nodes or other organs. After initial therapy, the disease can return (relapse) or fail to respond (refractory), leading to new growth of cancer cells. The returning or resistant cells keep dividing, causing the tumor to enlarge and possibly spread to other parts of the body. As the disease progresses, symptoms such as swelling, fatigue, and weight loss may become more noticeable.

Trial ID:

2025-523806-34-00

Protocol code:

UKD-IKF-Double-T

Trial Phase:

Therapeutic exploratory (Phase II)

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Glofitamab plus drug combination for relapsed/refractory large B‑cell lymphoma in high‑risk second‑line patients eligible for CAR‑T therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?