DLBCLPhase 1/2NCT04855253
Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL
A Phase 1/2 study testing E7777, Fludarabine and Cyclophosphamide in people with DLBCL and Diffuse Large B Cell Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
- What is being tested?
- E7777, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to Dec 2028
- Phase
- Phase 1/2
- 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
- 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
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- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to CAR-T Therapy for Relapsed/Refractory Large B-Cell Lymphomas
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
Read the 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).
- Conditions
- DLBCL, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, DLBCL Arising From Follicular Lymphoma
- Being tested
- E7777, Fludarabine, Cyclophosphamide, Tisagenlecleucel, Axicabtagene Ciloleucel
- Keywords
- E7777, Axicabtagene, Lisocabtagene, Tisagenlecleucel
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7777Drug
E7777 is a recombinant fusion toxin consisting of full-length human IL-2 fused to the catalytic domains of diphtheria toxin. E7777 is preferentially bound to and internalized by cells expressing the high affinity form (CD25+) of the IL-2 receptor.
FludarabineDrug
Fludarabine 25 mg/m2 IV daily for 3 days. Days -5, -4 and -3. Taken in combination with Cyclophosphamide
CyclophosphamideDrug
Cyclophosphamide 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine. Days -5, -4 and -3.
TisagenlecleucelDrug
Also called kymriah
Patient will receive one FDA approved CAR-T product - Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma
Axicabtagene CiloleucelDrug
Also called Yescarta
Patient will receive one FDA approved CAR-T product - Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma
Lisocabtagene Maraleucel Intravenous SuspensionDrug
Also called Breyanzi
Patient will receive one FDA approved CAR-T product - Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 : E7777 at 5 mcg/kg | Experimental | Single dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy Receives: Drug: E7777; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tisagenlecleucel; Drug: Axicabtagene Ciloleucel; Drug: Lisocabtagene Maraleucel Intravenous Suspension |
| Dose level 1 : E7777 at 7 mcg/kg | Experimental | Single dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy Receives: Drug: E7777; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tisagenlecleucel; Drug: Axicabtagene Ciloleucel; Drug: Lisocabtagene Maraleucel Intravenous Suspension |
| Dose level 1 : E7777 at 9 mcg/kg | Experimental | Single dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy Receives: Drug: E7777; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tisagenlecleucel; Drug: Axicabtagene Ciloleucel; Drug: Lisocabtagene Maraleucel Intravenous Suspension |
| MTD from phase 1 | Experimental | Single dose of E7777 (Maximum tolerated dose level identified in phase 1) given on Day -7 two days prior to the start of lymphodepleting chemotherapy Receives: Drug: E7777; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tisagenlecleucel; Drug: Axicabtagene Ciloleucel; Drug: Lisocabtagene Maraleucel Intravenous Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish maximum tolerated dose (MTD)
The primary objective of this Phase I study is to establish a maximum tolerated dose (MTD) of E7777 when given prior to standard of care CAR-T therapy product for the treatment of relapsed/refractory B-cell lymphoma who are at a higher risk for failure of CAR-T therapy.
Measured: 1 month
Secondary outcomes (7)
Number of participants experiencing adverse events
Number of participants experiencing adverse events related to E7777 to determine safety of the E7777
Measured: 100 days Post E7777 infusion
Number of participants experiencing disease free survival (DFS)
Number of participants experiencing disease free survival (DFS) at 1 year
Measured: 1 year Post E7777 infusion
Number of participants experiencing overall survival (OS)
Number of participants experiencing overall survival (DFS) at 1 year
Measured: 1 year Post E7777 infusion
Number of non-relapse mortality incidents at day 100
Number of participants experiencing non-relapse mortality at day 100 post E7777 infusion
Measured: 100 days Post E7777 infusion
Number of Grade 3 or 4 cytokine release syndrome (CRS) incidents
Number of participants experiencing Grade 3 or 4 cytokine release syndrome (CRS) after CAR-T cell therapy.
Measured: 28 Days Post E7777 infusion
Number of Grade 3 or 4 immune effector cell associated neurotoxicity (ICAN) syndrome incidents
Number of participants experiencing Grade 3 or 4 immune effector cell associated neurotoxicity (ICAN) syndrome after CAR-T cell therapy.
Measured: 28 Days Post E7777 infusion
Number of participants experiencing dose limiting toxicity events
Dose Limiting Toxicity (DLT) is defined as any of the following events based on CTCAE v5 from the 1st infusion of E7777 through 21 days after the administration of CAR-T:
- Grade 4 infusion related reaction (IRR) associated with E7777
- Grade 4 or Grade 3 capillary leak syndrome (CLS)
- Grade 3 or 4 liver function test abnormality that do not resolve to <Grade 2 within 5 days
- Grade 3 or 4 non-hematologic toxicity event that occurs after the administration of E7777 and before lymphodepleting therapy
- Any adverse event that results in a delay of lymphodepleting therapy for more than 72 hours and attributed to E7777
- Any Grade 5 adverse event
Measured: 28 Days Post E7777 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start9 Jun 2021
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Accrual met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DLBCLStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The Phase I study consists of two components: dose finding to establish a maximum tolerated dose (MTD) of E7777 and a small extension component to provide an estimate of efficacy at the MTD. A single dose of E7777 is given on Day -7, two days prior to the start of lymphodepleting chemotherapy. Up to 3 dose levels will be tested. The MTD is determined by using the continual reassessment method (CRM). Enrollment begins with Dose Level 1 using a cohort of two patients. Twenty one (21) days after the 2nd patient's CAR-T cell infusion the next cohort of 2 patients are assigned to the most appropriate strategy based on updated toxicity probabilities corresponding to the desired maximum toxicity rate of ≤ 25% as determined by the study statistician (or designee). Enrollment continues in cohorts of 2 separated by a minimum of 28 days until 20 patients are enrolled or 10 sequential patients are enrolled at the same dose level. No intra-cohort staggering is required.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronika Bachanova, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855253
- Sponsor's protocol ID
- 2020LS100
- Other IDs
- MT2020-27
- Status last verified
- Nov 2026
- First submitted
- 19 Apr 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mahdi HS, Woodall-Jappe M, Singh P, Czuczman MS. Targeting regulatory T cells by E7777 enhances CD8 T-cell-mediated anti-tumor activity and extends survival benefit of anti-PD-1 in solid tumor models. Front Immunol. 2023 Oct 27;14:1268979. doi: 10.3389/fimmu.2023.1268979. eCollection 2023.
PubMed 38022532
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to CAR-T Therapy for Relapsed/Refractory Large B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT04855253
- Acronym / sponsor ID
- 2020LS100
- Conditions
- DLBCL, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, DLBCL Arising From Follicular Lymphoma
- Keywords
- E7777, Axicabtagene, Lisocabtagene, Tisagenlecleucel
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Accrual met
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The Phase I study consists of two components: dose finding to establish a maximum tolerated dose (MTD) of E7777 and a small extension component to provide an estimate of efficacy at the MTD. A single dose of E7777 is given on Day -7, two days prior to the start of lymphodepleting chemotherapy. Up to 3 dose levels will be tested. The MTD is determined by using the continual reassessment method (CRM). Enrollment begins with Dose Level 1 using a cohort of two patients. Twenty one (21) days after the 2nd patient's CAR-T cell infusion the next cohort of 2 patients are assigned to the most appropriate strategy based on updated toxicity probabilities corresponding to the desired maximum toxicity rate of ≤ 25% as determined by the study statistician (or designee). Enrollment continues in cohorts of 2 separated by a minimum of 28 days until 20 patients are enrolled or 10 sequential patients are enrolled at the same dose level. No intra-cohort staggering is required.
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 : E7777 at 5 mcg/kg | Experimental | Drug: E7777, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Tisagenlecleucel, Drug: Axicabtagene Ciloleucel, Drug: Lisocabtagene Maraleucel Intravenous SuspensionSingle dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy |
| Dose level 1 : E7777 at 7 mcg/kg | Experimental | Drug: E7777, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Tisagenlecleucel, Drug: Axicabtagene Ciloleucel, Drug: Lisocabtagene Maraleucel Intravenous SuspensionSingle dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy |
| Dose level 1 : E7777 at 9 mcg/kg | Experimental | Drug: E7777, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Tisagenlecleucel, Drug: Axicabtagene Ciloleucel, Drug: Lisocabtagene Maraleucel Intravenous SuspensionSingle dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy |
| MTD from phase 1 | Experimental | Drug: E7777, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Tisagenlecleucel, Drug: Axicabtagene Ciloleucel, Drug: Lisocabtagene Maraleucel Intravenous SuspensionSingle dose of E7777 (Maximum tolerated dose level identified in phase 1) given on Day -7 two days prior to the start of lymphodepleting chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E7777E7777 is a recombinant fusion toxin consisting of full-length human IL-2 fused to the catalytic domains of diphtheria toxin. E7777 is preferentially bound to and internalized by cells expressing the high affinity form (CD25+) of the IL-2 receptor. | Drug | Dose level 1 : E7777 at 5 mcg/kg, Dose level 1 : E7777 at 7 mcg/kg, Dose level 1 : E7777 at 9 mcg/kg, MTD from phase 1 |
| FludarabineFludarabine 25 mg/m2 IV daily for 3 days. Days -5, -4 and -3. Taken in combination with Cyclophosphamide | Drug | Dose level 1 : E7777 at 5 mcg/kg, Dose level 1 : E7777 at 7 mcg/kg, Dose level 1 : E7777 at 9 mcg/kg, MTD from phase 1 |
| CyclophosphamideCyclophosphamide 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine. Days -5, -4 and -3. | Drug | Dose level 1 : E7777 at 5 mcg/kg, Dose level 1 : E7777 at 7 mcg/kg, Dose level 1 : E7777 at 9 mcg/kg, MTD from phase 1 |
| TisagenlecleucelAlso: kymriahPatient will receive one FDA approved CAR-T product - Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma | Drug | Dose level 1 : E7777 at 5 mcg/kg, Dose level 1 : E7777 at 7 mcg/kg, Dose level 1 : E7777 at 9 mcg/kg, MTD from phase 1 |
| Axicabtagene CiloleucelAlso: YescartaPatient will receive one FDA approved CAR-T product - Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma | Drug | Dose level 1 : E7777 at 5 mcg/kg, Dose level 1 : E7777 at 7 mcg/kg, Dose level 1 : E7777 at 9 mcg/kg, MTD from phase 1 |
| Lisocabtagene Maraleucel Intravenous SuspensionAlso: BreyanziPatient will receive one FDA approved CAR-T product - Tisagenlecleucel/Kymriah, Axicabtagene Ciloleucel/Yescarta, or lisocabtagene maraleucel/Breyanzi) for the treatment of relapsed/refractory diffuse large B-cell lymphoma | Drug | Dose level 1 : E7777 at 5 mcg/kg, Dose level 1 : E7777 at 7 mcg/kg, Dose level 1 : E7777 at 9 mcg/kg, MTD from phase 1 |
Primary outcome
Establish maximum tolerated dose (MTD)
Time frame: 1 month
The primary objective of this Phase I study is to establish a maximum tolerated dose (MTD) of E7777 when given prior to standard of care CAR-T therapy product for the treatment of relapsed/refractory B-cell lymphoma who are at a higher risk for failure of CAR-T therapy.
7 secondary outcomes
Number of participants experiencing adverse events
Time frame: 100 days Post E7777 infusion
Number of participants experiencing disease free survival (DFS)
Time frame: 1 year Post E7777 infusion
Number of participants experiencing overall survival (OS)
Time frame: 1 year Post E7777 infusion
Number of non-relapse mortality incidents at day 100
Time frame: 100 days Post E7777 infusion
Number of Grade 3 or 4 cytokine release syndrome (CRS) incidents
Time frame: 28 Days Post E7777 infusion
Number of Grade 3 or 4 immune effector cell associated neurotoxicity (ICAN) syndrome incidents
Time frame: 28 Days Post E7777 infusion
Number of participants experiencing dose limiting toxicity events
Time frame: 28 Days Post E7777 infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 38022532Mahdi HS, Woodall-Jappe M, Singh P, Czuczman MS. Targeting regulatory T cells by E7777 enhances CD8 T-cell-mediated anti-tumor activity and extends survival benefit of anti-PD-1 in solid tumor models. Front Immunol. 2023 Oct 27;14:1268979. doi: 10.3389/fimmu.2023.1268979. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronika Bachanova, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing E7777, Fludarabine and Cyclophosphamide in people with DLBCL and Diffuse Large B Cell Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
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 21 inclusion and 11 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: paused, as of the sponsor's last update on 4 Nov 2026. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Establish maximum tolerated dose (MTD) (time frame: 1 month). 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 NCT04855253, which also lists 1 linked publication.
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 Nov 2026.