Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL (NCT04855253) | Clinical Trial Compass
SuspendedPhase 1/2
Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL
Stopped: Accrual met
United States30 participantsStarted 2021-06-09
Plain-language summary
This is a multicenter Phase I study to determine the maximum tolerated dose (MTD) of E7777 when given prior to cyclophosphamide/fludarabine (CY/Flu) lymphodepletion (LD) chemotherapy and an FDAapproved CAR-T product Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma grade 3 who are at a higher risk for failure of CAR-T therapy
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Establish maximum tolerated dose (MTD)
Timeframe: 1 month
Trial details
NCT IDNCT04855253
SponsorMasonic Cancer Center, University of Minnesota