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Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL | Clinical Trials | Clareo Health

SUSPENDEDPHASE1/PHASE2

Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL

Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to CAR-T Therapy for Relapsed/Refractory Large B-Cell Lymphomas

NCT04855253•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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

Detailed Description

E7777 is a recombinant fusion toxin consisting of full-length human IL-2 fused to the catalytic domains of diphtheria toxin. This trial is designed to augment lymphodepletion prior to CAR-T cells by administration of a targeted immunotoxin against CD25-expressing T-cells. CD25 is expressed at high levels on Tregs but also on activated effector T cells. The use of the CAR-T cell product and associated apheresis and LD chemotherapy is considered standard of care (SOC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+11 more criteria

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
+1 more criteria

Locations (1)

University of Minnesota, Masonic Cancer Center

Minneapolis, Minnesota, United States

Key Dates

Start Date

June 9, 2021

Primary Completion Date

September 1, 2026

Completion Date

December 1, 2026

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

DLBCLDiffuse Large B Cell LymphomaHigh-grade B-cell LymphomaDLBCL Arising From Follicular Lymphoma

Interventions

E7777

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Tisagenlecleucel

DRUG

Axicabtagene Ciloleucel

DRUG

Lisocabtagene Maraleucel Intravenous Suspension

DRUG

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

View study

RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies