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Relapsed /Refractory DLBCLPhase 2NCT07542678

Double-T - Improving Outcomes in High-risk 2nd Line Relapsed/Refractory Large B-Cell Lymphoma Patients Eligible for CAR-T-cell Therapy With a Glofitamab-based Induction and Consolidation Concept

A Phase 2 study testing Glofitamab, Gemcitabine, and Oxaliplatin as Induction Therapy and Glofitamab as Consolidation therapy in people with Relapsed /Refractory DLBCL, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 5 sites in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The Double-T trial is a prospective, randomized, single-arm, open-label, multicenter phase II trial investigating a double T-cell therapy strategy, which includes glofitamab with gemcitabine/oxaliplatin (Glofi-Gem/Ox) prior to and glofitamab monotherapy consolidation after standard of care Chimeric Antigen Receptor… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Relapsed /Refractory DLBCL
What is being tested?
Glofitamab, Gemcitabine, and Oxaliplatin as Induction Therapy and Glofitamab as Consolidation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesGermany
Study dates
Apr 2026to Apr 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient* has given written informed consent.
  • Patient is 18-80 years of age at time of signing the written informed consent
  • Patient has histologically confirmed diagnosis of large B-cell lymphoma by local pathologist at time of relapse.
  • Patient received R-CHOP based first-line therapy containing a CD20-antibody and anthracyclines.
  • Patient has relapsed/refractory disease, defined as follows:
  • Relapsed: disease that had recurred following partial or complete response (PR/CR) within 12 months of adequate first-line therapy
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  • Refractory: disease that did not respond to, or that progressed <6 months after, completion of first-line therapy
  • Patient has at least one FDG-PET positive bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi dimensionally measurable (>1 cm extranodal lesion, as measured on computed tomography (CT) scan
  • Patient has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 2
  • Patient has an absolute lymphocyte count > 200/µL
  • Patient is eligible for CAR-T cell therapy as per investigator´s discretion meeting all of the following criteria of adequate organ function:
  • Adequate kidney function, defined as: Serum creatinine estimated glomerular filtration rate (MDRD) ≥ 60 mL/min.
  • Adequate hepatic function, defined as: ALAT and ASAT ≤ 5 ULN. Bilirubin
  • ≤ 2.0 mg/dl (except for Meulengracht disease)
  • Adequate bone marrow function, defined as: Absolute neutrophil count (ANC) ≥ 1000/µL, Platelets ≥ 50.000/µL and Hemoglobin > 8.0 g/dL.
  • Adequate cardiac function, defined as: Cardiac ejection fraction ≥ 45%.
  • Adequate pulmonary function as per investigators discretion
  • Patient successfully performed MNC-leucapheresis procedure for a commercially available CAR-T-cell product
  • Patient is willing and able to provide baseline biopsy material (archival or fresh tumor sample) for central review
  • Male patients with female partners of childbearing potential are eligible to participate if they agree to contraceptive methods throughout the duration of the trial and at least 18 months after obinutuzumab administration, 12 months after lost dose oxaliplatin, 6 months after lymphodepletion or 2 months after last dose glofitamab, whatever is last
  • Female participants of childbearing potential must agree to use a highly effective method of contraception (e.g., hormonal contraception, intrauterine device (IUD), or surgical sterilization) throughout the duration of the trial and at least 18 months after obinutuzumab administration, 15 months after lost dose oxaliplatin, 6 months after lymphodepletion or 2 months after last dose glofitamab, whatever is last. * There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the trial gender-independently

Who cannot join

  • Patient has HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR during screening
  • Patient has previous or concurrent malignancies with the following exceptions:
  • Surgically cured carcinoma in-situ
  • Other kinds of cancer without evidence of disease for at least 3 years
  • Patient has known hypersensitivity to any component of the Glofitamab, Obinutuzumab, Yescarta and/or Breyanzi formulation formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to one of the other trial drugs
  • Patient has severe active infection requiring iv treatment within 14 days prior first dose of study drugs
Show all 22Show fewer
  • Patient has congenital or acquired immunodeficiency including previous organ or allogeneic stem cell transplantation
  • Patient received prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
  • Patient received prior treatment with gemcitabine and oxaliplatin in prior lymphoma treatment line
  • Patient had a major surgery within 4 weeks prior to first dose of study drugs
  • Patient has primary or secondary central nervous system (CNS) lymphoma at the time of enrollment or history of CNS lymphoma
  • Patient has current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Patient has significant or extensive cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina
  • Patient has an active autoimmune disease requiring systemic treatment
  • Patient receives ongoing corticosteroid use >20 mg/day of prednisone or equivalent. Patients on stable low-dose corticosteroids (≤20 mg/day of prednisone or equivalent for at least 7-14 days prior to first IMP administration) or on short courses of higher-dose corticosteroids that are completed before first IMP administration are eligible.
  • Female patients who are pregnant or breast feeding or planning to become pregnant within up to 18 months after start of treatment. Female patients of childbearing potential must have a negative serum pregnancy test result within 3 days prior to initiation of trial treatment.
  • Patient has a relationship of dependence or employer-employee relationship to the sponsor or the investigator
  • Patient lacks accountability and inability to appreciate the nature, meaning and consequences of the trial
  • Patient is non-compliant, for reasons including, but not limited to the following:
  • Increased alcohol consumption, drug dependency or substance abuse that would interfere with cooperation with requirements of the trial
  • Refusal of blood products during treatment
  • Any similar circumstances that appear to make protocol treatment or follow-up impossible

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Birte Friedrichs, Dr. contact

birte.friedrichs@med.uni-duesseldorf.de

Johanna Riedel contact

double-t@ikf-khnw.de

5 sites in 1 country

Germany5 sites

  • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

    Berlin, State of Berlin, 12203

    Björn Chapuy, Prof. Dr.

  • Universitätsklinikum Düsseldorf - Klinik für Hämatologie, Onkologie und klinische Immunologie

    Düsseldorf, North Rhine-Westphalia, 40225

    Sascha Dietrich, Prof. Dr.

  • Universitätsklinikum Essen (AöR) - Westdeutsches Tumorzentrum Essen - Klinik für Hämatologie und Stammzellltransplantation

    Essen, North Rhine-Westphalia, 45147

    Bastian von Tresckow, Prof. Dr.

  • Universitätsklinikum Heidelberg - Innere Medizin V

    Heidelberg, Baden-Wurttemberg, 69120

    Peter Dreger, Prof. Dr.

  • Universitätsklinikum Münster - Medizinische Klinik A

    Münster, North Rhine-Westphalia, 48149

    Evgenii Shumilov, PD Dr.

Other trials in Germany

About this study

The Double-T trial is a prospective, randomized, single-arm, open-label, multicenter phase II trial investigating a double T-cell therapy strategy, which includes glofitamab with gemcitabine/oxaliplatin (Glofi-Gem/Ox) prior to and glofitamab monotherapy consolidation after standard of care Chimeric Antigen Receptor (CAR)-T cell therapy in high-risk 2nd line relapsed/refractory Large B-Cell Lymphoma (r/r LBCL) patients.

Data on safety, efficacy, and quality of life (QoL) will be collected and analyzed.

Being tested
Glofitamab, Gemcitabine, and Oxaliplatin as Induction Therapy, Glofitamab as Consolidation therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glofitamab, Gemcitabine, and Oxaliplatin as Induction TherapyDrug

    Induction Therapy before Standard of Care CAR-T Cell therapy

  • Glofitamab as Consolidation therapyDrug

    Consolidation with Glofitamab after CAR-T Cell Therapy

Study groups in NCT07542678
Study groupRoleWhat they receive
Double-TExperimentalglofitamab with gemcitabine/oxaliplatin (Glofi-Gem/Ox) prior to and glofitamab monotherapy consolidation after standard of care CAR-T cell therapy
Receives: Drug: Glofitamab, Gemcitabine, and Oxaliplatin as Induction Therapy; Drug: Glofitamab as Consolidation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CRR@EOT

    Complete response rate (CRR) at end of treatment (CCR@EOT), defined as proportion of patients who achieved complete response (CR) at the end of trial treatment (EOT) as per Lugano classification

    Measured: at the end of trial treatment, on average after 10 months

Secondary outcomes (15)

  1. CCR@pIT and CCR@3MpCT

    CRR post induction (CCR@pIT) and at 3 months post-CAR-T cell infusion (CCR@3MpCT), defined as proportion of patients who achieved complete response after two cycles induction treatment and 3 months after CAR-T cell infusion as per Lugano classification

    Measured: post induction (after 6 weeks) and 3 months post-CAR-T cell infusion (after 4,5 months)

  2. Overall CRR

    Overall CRR, defined as proportion of patients who achieved CR as best overall response (BOR)

    Measured: from first Investigational Medicinal Product (IMP) administration until end of follow-up, on average 2,5 years

  3. ORR post induction, at 3 months post-CAR-T cell infusion, and at EOT

    Objective Response rate (ORR) post induction (OOR@pIT), at 3 months post-CAR T cell infusion (ORR@3MpCT) and at end of trial treatment (ORR@EOT), defined as proportion of patients who achieved complete or partial response (CR/PR) after 2 cycles of induction treatment, at 3 months after CAR-T cell infusion and at the end of the treatment

    Measured: post induction (after 6 weeks), at 3 months post-CAR-T cell infusion (after 4,5 months), and at end of trial treatment (on average after 10 months)

  4. Overall ORR

    Overall ORR, defined as proportion of patients who achieved CR/PR as BOR

    Measured: from first IMP administration until end of follow-up, on average 2,5 years

  5. Best overall response (BOR) rate

    Best overall response (BOR) rate

    Measured: from first IMP administration until end of follow-up, on average 2,5 years

  6. PFS

    Progression-free survival (PFS) plus PFS rate at one and two years, defined as time from start of treatment until date of progression or death due to any cause

    Measured: from first IMP administration until end of follow-up, on average 2,5 years

  7. OS

    Overall survival (OS) plus OS rate at one and two years, defined as time from start of treatment until death due to any cause

    Measured: from first IMP administration until end of follow-up, on average 2,5 years

  8. CAR-T cell expansion

    Quantification of peak CAR-T cell expansion in peripheral blood following glofitamab consolidation (measured by flow cytometry and/or qPCR for CAR transgene)

    Measured: from CAR-T Cell infusion until End of treatment visit (on average after 10 months)

  9. Time to peak CAR-T cell expansion post-infusion

    Time to peak CAR-T cell expansion post-infusion

    Measured: from CAR-T Cell infusion until End of treatment visit (on average after 10 months)

  10. CAR-T cell persistence

    Duration of CAR-T cell persistence in peripheral blood (up to end of evaluation period or loss of detectability)

    Measured: from CAR-T Cell infusion until End of treatment visit (on average after 10 months)

  11. Correlation between CAR-T cell expansion/persistence and clinical response

    Correlation between CAR-T cell expansion/persistence and clinical response (e.g., CR, PR, PFS)

    Measured: End of study, after 3 years

  12. Quality of life (QLQ-C30)

    Quality of life (QoL) over time as determined by EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 is a widely used, validated, 30-question, self-report questionnaire designed to assess the quality of life of cancer patients. It covers functional scales, symptom scales, and global health status. The questionnaire uses a Likert scale for responses, typically ranging from 1 ("Not at all") to 4 ("Very much"). Global health status/QoL is scaled from 1 ("very poor") to 7 ("Excellent"). The data collected is used to score 10 subscales, providing a multidimensional overview of a patient's quality of life.

    Measured: From Screening until End of treatment visit (on average after 10 months)

  13. Adverse events

    Assessment of safety of the treatment as determined by the incidence, type, causality, frequency, timing, severity and seriousness of adverse events using NCI CTCAE 6.0

    Measured: from first IMP administration until end of follow-up, on average 2,5 years

  14. Adverse events of special interest

    Incidence of AEs of special Interest (AESIs) as defined in protocol

    Measured: from first IMP administration until end of follow-up, on average 2,5 years

  15. Proportion of patients completing all planned cycles (Tolerability)

    Tolerability as determined by proportion of patients completing all planned cycles

    Measured: from first IMP administration until end of treatment, on average 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07542678
Sponsor's protocol ID
UKD-IKF-Double-T
Other IDs
2025-523806-34-00, 2025
Status last verified
Apr 2026
First submitted
2 Apr 2026
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glofitamab, Gemcitabine, and Oxaliplatin as Induction Therapy and Glofitamab as Consolidation therapy in people with Relapsed /Refractory DLBCL, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Birte Friedrichs, Dr. (birte.friedrichs@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CRR@EOT (time frame: at the end of trial treatment, on average after 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07542678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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