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New combo aims to boost CAR-T success in hard-to-treat lymphomas
NCT ID NCT04855253
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding an experimental drug called E7777 before standard CAR-T therapy can help people with aggressive B-cell lymphomas that have come back or not responded to treatment. About 30 participants will receive E7777 followed by chemotherapy and a CAR-T product. The goal is to find the safest dose and see if this approach improves disease control.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of a relapse or refractory (r/r) B cell lymphoma, for which treatment with tisagenleucel (Kymriah), Axicabtagene (Yescarta) or Lisocabtagene Maraleucel (Breyanzi) is planned, including : * diffuse large B-cell lymphoma (DLBCL) not otherwise specified, * high grade B-cell lymphoma * DLBCL arising from follicular lymphoma * Primary mediastinal B cell lymphoma * Follicular lymphoma grade 3B * And considered at high risk for progression after CAR-T therapy by meeting one or more of the following factors: * refractory to last line of therapy/remission of less than 12 months * myc over expression \>40% in any prior biopsy or bcl2/bcl6 and c-myc re-arrangement (double/triple hit) * 2 sites of extranodal disease * IPI ≥ 3 * Elevated LDH at the time of relapse * Has secured coverage for Kymriah, Yescarta,Breyanzi administration * Age 18 years or older at the time of signing the consent * ECOG Performance status of 0, 1, or 2 * Adequate bone marrow reserve (may be transfusion dependent) * Adequate organ function at enrollment and within 14 days of planned E7777 treatment as defined in Section 4.1.7 * Hemodynamically stable and LVEF ≥ 50% confirmed by echocardiogram or MUGA * Grade 1 dyspnea (CTCAE v5) and SpO2 \> 91% on room air * Sexually active females of child-bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy * Provides voluntary written consent prior to the performance of any research related activities. Exclusion Criteria: * Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing) * Known bone marrow involvement, if history of bone marrow involvement must have a BM biopsy to rule-out current involvement * Prior allogeneic transplant * Ocular disease or complaints visual acuity impairment, color or shape distortion, or blurred vision - potential participants are required to have an ophthalmological examine as part of screening * Active CNS involvement by malignancy (history of CNS disease with negative CSF by flow cytometry and/or stable findings on brain MRI are acceptable) * Uncontrolled active hepatitis B or hepatitis C * Active or inactive HIV infection * Untreated active bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to enrollment) * History of heart failure or pulmonary edema, evidence of pleural effusion or active lower extremity edema * Uncontrolled unstable angina and/or myocardial infarction within 3 months of enrollment * Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
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Other studies related to the condition(s) this trial covers.
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- A CAR-T therapy given by injection: can it help Hard-to-Treat lymphoma?
- New drug joins standard chemotherapy in fight against B-Cell lymphoma