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B-cell Lymphoma RefractoryPhase 2PRIME-CARNCT06912529

Axicabtagene Ciloleucel CAR T-cells in Patients With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma

A Phase 2 study testing Leukapheresis, Bridging Therapy and Lymphodepletion in people with B-cell Lymphoma Refractory and B-cell Lymphoma Recurrent, run by Universität Münster at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II study will evaluate the efficacy, safety and tolerability of second-line treatment with axicabtagene ciloleucel in primary mediastinal B-cell lymphoma patients (PMBCL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Leukapheresis, Bridging Therapy and Lymphodepletion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteGermany
Study dates
13 Mar 2025to 25 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent form (ICF) according to ICH/EU GCP and national regulations
  • Age > 18 years
  • ECOG performance status < 2
  • Histologically confirmed primary mediastinal B-cell lymphoma (PMBCL)
  • based on the 2022 World Health Organization (WHO) (R. Allagio et al.)
  • classification by local pathology laboratory assessment
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  • Patients must have received adequate first-line therapy including:
  • An anti-CD20 monoclonal antibody (rituximab), and
  • CHOP or CHOP-like chemotherapy Note: CHOP-like chemotherapy corresponds to CHOEP, ACVBP or EPOCH or COPADEM. Patients who received dose-reduced CHOP (e.g., mini-CHOP) are excluded except for dose reductions of vincristine due to peripheral neuropathy. Patients who have received additional drugs in combination with CHOP or CHOP-like regimen are eligible.
  • Relapsed or refractory disease after first-line chemoimmunotherapy, documented by PET-CT:
  • Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse
  • Refractory disease defined as:
  • Progressive disease (PD) during first-line therapy
  • Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP) and biopsy-proven residual disease, or
  • Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease
  • At least 2 weeks must have elapsed since any prior systemic cancer therapy at the time the patient provides consent
  • Lymphoma tissue at recurrence available for central pathologic examination, exploratory endpoints, and ancillary studies (detailed sample collection requirements are described in protocol section 8.2)
  • Patients must have at least 1 measurable lesion per the Lugano Classification on anatomical imaging such as computed tomography (CT) imaging (functional imaging such as PET may not be used to identify a measurable lesion). A measurable lesion is defined as greater than 1.5 cm LDi for lymph node and greater than 1.0 cm LDi for extranodal lesions
  • Patients must be eligible for CAR T-cells as defined by:
  • Patient deemed eligible for CAR T-cells therapy by the study physician
  • Adequate vascular access for leukapheresis procedure (either peripheral or central venous line)
  • Adequate bone marrow, renal, hepatic, cardiac and pulmonary function defined as:
  • Absolute neutrophil count (ANC) ≥ 1000 cells/μL
  • Absolute lymphocyte count > 100/μL
  • Platelets ≥ 75,000 cells/μL
  • Creatinine clearance (as estimated by Cockcroft Gault) ≥ 40 ml/min
  • Transaminases (AST and ALT) <2.5 x ULN
  • Total bilirubin < 1.5 x ULN unless other reason known (Gilbert-Meulengracht-Syndrome in which 3 x ULN would be acceptable)
  • Left ventricular ejection fraction (LVEF) ≥ 40% and no evidence of clinically significant pericardial effusion, and no significant abnormal electrocardiogram (ECG) findings
  • No evidence of Grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] 5.0) or greater pleural effusion or ascites (subjects with Grade 1 ascites or pleural effusion are eligible)
  • Baseline oxygen saturation > 92% on room air
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing potential)
  • Sexually active men and FCBP must agree to use one of the highly effective contraceptive methods (combined oral contraceptives using two hormones, contraceptive implants, injectables, intrauterine devices, sterilized partner) together with one of the barrier methods (latex condoms, diaphragms, contraceptive caps) while on study; this should be maintained for 12 months after the last dose of study drug
  • Willingness not to drive a vehicle for 8 weeks post CAR T-cell treatment

Who cannot join

  • Patients who received more than one prior line of systemic therapy
  • Prior CD19-targeted therapy
  • History of another primary malignancy that has not been in remission for at least 2 years (except for non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast)). A maintenance treatment is not allowed
  • History or presence of non-malignant CNS disorder, such as seizure disorder requiring anti-convulsive therapy, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema with confirmed structural defects by appropriate imaging. History of stroke or transient ischemic attack within 12 months prior to enrollment.
  • Secondary CNS involvement of PMBCL is not an exclusion criterion
  • History of acute or chronic active hepatitis B or C infection. If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing
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  • Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a CD4 count > 200 cells/μl
  • Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal catheter). Dedicated venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted
  • Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antimicrobials at the time of enrollment
  • Presence of cardiac atrial or ventricular lymphoma involvement
  • History of any one of the following cardiovascular conditions within the past 12 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
  • History of any medical condition including but not limited to autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression and/or systemic disease modifying agents within the last year. Endocrine conditions that require maintenance with physiologic dose steroids are allowed
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed
  • History of severe immediate hypersensitivity reaction to any of the agents used in this study, including aminoglycosides, cyclophosphamide, fludarabine or tocilizumab
  • Treatment with a live, attenuated vaccine within 6 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study
  • FCBP who are pregnant or breastfeeding
  • In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
  • Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
  • Simultaneously active participation in another clinical trial involving an IMP within 30 days prior to enrolment into this clinical trial
  • Patients with a physical or psychiatric condition which at the investigator's discretion may put the patient at risk, may confound the trial results, or may interfere with the patient's participation in this clinical trial
  • Known or persistent abuse of medication, drugs or alcohol
  • History of deep vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within 6 months of enrollment
  • Primary immunodeficiency
  • Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
  • Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow up schedule

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Medizinische Klinik A Hämatologie, Hämostaseologie, Onkologie und Pneumologie Universitätsklinikum Münster

    Münster, 48149

Other trials in Germany

About this study

This phase II study will evaluate the efficacy, safety and tolerability of second-line treatment with axicabtagene ciloleucel in primary mediastinal B-cell lymphoma patients (PMBCL).

Read the detailed description

Patients who are refractory or relapse after first-line therapy of PMBCL have poor outcomes when treated with standard salvage therapy consisting of high-dose therapy and autologous stem cell transplantation. Recent studies and real-world data on CAR T-cells in patients with early relapsed or refractory aggressive B-cell lymphoma, particularly diffuse large cell B-Cell lymphoma, showed improved event free survival and overall survival with axicabtagene ciloleucel compared with the previous standard of care. These reports suggest comparable efficacy with similar toxicity profiles for CAR T-cells in PMBCL. However, larger studies with CAR T-cells in patients who are refractory to first-line therapy or who relapse after an initial response are urgently needed.

Being tested
Leukapheresis, Bridging Therapy, Lymphodepletion, Axicabtagene Ciloleucel

What participants receive

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

  • LeukapheresisProcedure or surgery

    Also called apheresis

    Axicabtagene ciloleucel is prepared from the patient's peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure.

  • Bridging TherapyDrug

    Bridging therapy refers to treatment used to control a patient's disease or disease related inflammation prior to lymphodepletion.

  • LymphodepletionDrug

    Patients will receive a non-myeloablative lymphodepleting regimen consisting of fludarabine and cyclophosphamide (FC) to induce lymphocyte depletion and create an optimal environment for expansion of axicabtagene ciloleucel in vivo.

  • Axicabtagene CiloleucelGenetic

    Also called axi-cel

    Patient will receive the axicabtagene ciloleucel infusion in the hospital followed by daily monitoring in the hospital.

Study groups in NCT06912529
Study groupRoleWhat they receive
Treatment armExperimentalWhile completing the screening process corticoid therapy may be continued up 7 days prior to leukapheresis. After leukapheresis, one cycle of any therapy can be given as bridging therapy to reduce tumor burden if clinically necessary. Lymphodepletion (LD) can be started after PET-CT-based staging. LD consists of lymphocyte depleting chemotherapy with fludarabine and cyclophosphamide (FC) applied on day -5 to day -3 followed by administration of axicabtagene ciloleucel on day 0. Patients will be observed as inpatients until at least day 10. Once the patient is discharged, outpatient visits including PET-CT-based staging are required on day 30 (±2 days), day 100 (±7 days), month 6 and 12 after axicabtagene ciloleucel administration.
Receives: Procedure: Leukapheresis; Drug: Bridging Therapy; Drug: Lymphodepletion; Genetic: Axicabtagene Ciloleucel

What is being measured

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

  1. Complete metabolic response (CMR)

    Complete metabolic response at 3 months from axicabtagene ciloleucel infusion (without additional anticancer therapy). Assessment of response will be based on the Lugano classification.

    Measured: 3 months from axicabtagene ciloleucel infusion

Secondary outcomes (10)

  1. Best response rate

    Best response rate is defined as the percentage of responder determined investigator disease assessment (INV) among all patients between day 30 and 12 months from axicabtagene ciloleucel infusion.

    Measured: between day 30 and 12 months from axicabtagene ciloleucel infusion

  2. Duration of complete metabolic response (DOCMR)

    The time from attainment of CMR to the date of first documented disease progression/relapsed (based on investigator disease assessment (INV)) or lymphoma-related deaths

    Measured: 3 months from axicabtagene ciloleucel infusion

  3. Time to first response

    Time from axicabtagene ciloleucel infusion after which the first response (CMR without additional anticancer therapy/PMR at day 30, 3 months, 6 months, 12 months) has ocurred

    Measured: time from axicabtagene ciloleucel infusion after which the first response (CMR without additional anticancer therapy/PMR at 30 days, 3 months, 6 months and 12 months) has ocurredhas occurred

  4. Relapse rate (RR)

    Number of relapses divided by the number of patients included with complete metabolic response (CMR) at 3 months from axicabtagene ciloleucel infusion (without additional anticancer therapy) based on investigator disease asessment (INV)

    Measured: 3 months from axicabtagene ciloleucel infusion

  5. Progression-free survival (PFS)

    Time from enrolment to the first observation of documented disease progression/relapsed (based on INV) or death due to any cause

    Measured: until last visit of patient, assessed up to 24 months

  6. Progression-free survival modified (mPFS)

    Time from axicabtagene ciloleucel infusion to the first observation of documented disease progression/relapsed (based on INV)) or death due to any cause

    Measured: until last visit of patient, assessed up to 24 months

  7. Event-free survival (EFS)

    Time from enrolment to failure to achieve a CMR at 12 months post CAR infusion, or start of any new lymphoma therapy, or the first observation of documented disease progression/relapsed (based on INV)) or death due to any cause, whichever comes first.

    Measured: until last visit of patient, assessed up to 24 months

  8. Modified EFS (mEFS)

    Time from axicabtagene ciloleucel infusion to failure to achieve a CMR at 12 months post CAR infusion, or start of any new lymphoma therapy, or to the first observation of documented disease progression/relapsed (based on INV)), or death due to any cause, whichever comes first.

    Measured: until last visit of patient, assessed up to 24 months

  9. Overall survival (OS)

    Time from enrolment to the date of death from any cause.

    Measured: From enrollment to the date of death. Alive patients will be censored at the last date where it is known that the patient is still alive, assessed up to 24 months

  10. Overall survival modified (mOS)

    From date of the axicabtagene ciloleucel infusion to the date of death from any cause.

    Measured: From date of axicabtagene ciloleucel infusion to the date of death. Alive patients will be censored at the last date where it is known that the patient is still alive, assessed up to 24 months

Timeline

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

  1. First posted4 Apr 2025
  2. Study start13 Mar 2025
  3. Primary completion25 Jul 2025
  4. Study completion25 Jul 2025

Why it stopped: Funder of the study terminated contract

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06912529
Sponsor's protocol ID
UniMS23_0018
Other IDs
2024-510972-19-00
Acronym
PRIME-CAR
Status last verified
Mar 2025
First submitted
24 Mar 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes
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 Leukapheresis, Bridging Therapy and Lymphodepletion in people with B-cell Lymphoma Refractory and B-cell Lymphoma Recurrent, run by Universität Münster at 1 site 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 34 inclusion and 25 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: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was stopped early (reason given: Funder of the study terminated contract). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete metabolic response (CMR) (time frame: 3 months from axicabtagene ciloleucel infusion). 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 NCT06912529.

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 4 Sep 2025.

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