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 range18 Years
SexALL
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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…
What they're measuring
1
Establish maximum tolerated dose (MTD)
Timeframe: 1 month
Trial details
NCT IDNCT04855253
SponsorMasonic Cancer Center, University of Minnesota