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E7777 Before CAR-T Therapy for Lymphoma
Phase 1 & 2
Recruiting
Led By Murali Janakiram, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate bone marrow reserve defined as: Absolute neutrophil count (ANC) > 1,000/mm^3, Platelets ≥ 50,000/mm^3 (transfusion support can be provided), Hemoglobin >8.0 mg/dl (transfusion support can be provided) Bone marrow involvement at disease assessment is an exclusion as these patients are at an increased risk of severe CRS and/or neurotoxicity
Diagnosis of a relapse or refractory (r/r) large B cell lymphoma, for which treatment with Kymriah is planned, including: diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma, DLBCL arising from follicular lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post e7777 infusion
Awards & highlights
Study Summary
This trial is to find the highest dose of E7777 that can be given with chemotherapy to people with DLBCL who have a higher chance of CAR-T therapy not working.
Who is the study for?
Adults with relapsed/refractory large B-cell lymphoma at high risk after CAR-T therapy, who have not had allogeneic transplants or CNS malignancy involvement, and are not pregnant. They must have adequate organ function, no severe heart issues or uncontrolled infections, and agree to use birth control.Check my eligibility
What is being tested?
The trial is testing the maximum tolerated dose of E7777 given before standard chemotherapy (CY/Flu) and Kymriah for treating high-risk patients with diffuse large B-cell lymphoma who might not respond well to CAR-T therapy alone.See study design
What are the potential side effects?
Potential side effects of E7777 may include reactions related to immune system activation, infusion-related symptoms, impact on blood counts leading to increased infection risk or bleeding tendencies. Specific side effects will be monitored closely due to the novel combination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood counts meet the required levels and my bone marrow is not affected by my disease.
Select...
I have a type of large B cell lymphoma and plan to be treated with Kymriah.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post e7777 infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post e7777 infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants experiencing dose limiting toxicity events
Secondary outcome measures
Number of Grade 3 or 4 cytokine release syndrome (CRS) incidents
Number of Grade 3 or 4 immune effector cell associated neurotoxicity (ICAN) syndrome incidents
Number of non-relapse mortality incidents at day 100
+3 moreSide effects data
From 2019 Phase 2 trial • 45 Patients • NCT0267677882%
Lymphopenia
76%
Aspartate aminotransferase increased
76%
Alanine aminotransferase increased
71%
Hypoalbuminaemia
53%
Gamma-glutamyltransferase increased
53%
Pyrexia
53%
Thrombocytopenia
35%
Lipase increased
29%
Nausea
29%
Oedema peripheral
29%
Decreased appetite
29%
Hypertriglyceridaemia
24%
Malaise
24%
Constipation
24%
Vomiting
24%
Weight increased
24%
Leukopenia
18%
Insomnia
18%
Anaemia
18%
Hyponatraemia
18%
Dehydration
18%
Hypokalaemia
18%
Hypophosphataemia
18%
Fatigue
18%
Blood cholesterol increased
18%
Blood lactate dehydrogenase increased
18%
Dysgeusia
18%
Amylase increased
12%
Hyperglycaemia
12%
Diarrhoea
12%
Tumour associated fever
12%
Weight decreased
12%
Neutropenia
12%
Stomatitis
12%
Lung infection
12%
Blood alkaline phosphatase increased
12%
Proteinuria
6%
Angular cheilitis
6%
Brain natriuretic peptide increased
6%
Pneumonia
6%
Dermatosis
6%
Conjunctivitis allergic
6%
Hypertension
6%
Dermatitis exfoliative generalised
6%
Face oedema
6%
Dysphagia
6%
Cytomegalovirus test positive
6%
Hypothyroidism
6%
Hypoacusis
6%
Sinus tachycardia
6%
Altered state of consciousness
6%
Electrocardiogram QT prolonged
6%
Cytomegalovirus chorioretinitis
6%
Sinus bradycardia
6%
Cancer pain
6%
Delirium
6%
Vasculitis
6%
Vessel puncture site erythema
6%
Drug hypersensitivity
6%
Peripheral sensory neuropathy
6%
Oropharyngeal pain
6%
Gingival pain
6%
Nasopharyngitis
6%
Parotitis
6%
Blood creatine phosphokinase increased
6%
Blood bilirubin increased
6%
N-terminal prohormone brain natriuretic peptide increased
6%
Tumour lysis syndrome
6%
Musculoskeletal stiffness
6%
Cough
6%
Laryngeal pain
6%
Laryngeal haemorrhage
6%
Drug eruption
6%
Lymphocytosis
6%
Cardiomegaly
6%
Supraventricular extrasystoles
6%
Ventricular arrhythmia
6%
Eye pain
6%
Eczema eyelids
6%
Ascites
6%
Colitis
6%
Haemorrhoids
6%
Perianal erythema
6%
Cellulitis
6%
Conjunctivitis
6%
Folliculitis
6%
Gastroenteritis
6%
Upper respiratory tract infection
6%
Blood creatinine increased
6%
Blood fibrinogen decreased
6%
Blood urea increased
6%
Hyperuricaemia
6%
Arthralgia
6%
Tumour pain
6%
Headache
6%
Hallucination, auditory
6%
Upper respiratory tract inflammation
6%
Rash generalised
100%
80%
60%
40%
20%
0%
Study treatment Arm
PTCL: E7777 9 mcg/kg/Day
CTCL: E7777 9 mcg/kg/Day
Other: E7777 9 mcg/kg/Day
Trial Design
4Treatment groups
Experimental Treatment
Group I: MTD from phase 1Experimental Treatment1 Intervention
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
Group II: Dose level 1 : E7777 at 9 mcg/kgExperimental Treatment1 Intervention
Single dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy
Group III: Dose level 1 : E7777 at 7 mcg/kgExperimental Treatment1 Intervention
Single dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy
Group IV: Dose level 1 : E7777 at 5 mcg/kgExperimental Treatment1 Intervention
Single dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E7777
2016
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,595 Total Patients Enrolled
Murali Janakiram, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
Veronika Bachanova, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
5 Previous Clinical Trials
675 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs in the week before my cell collection or CAR-T therapy.My blood counts meet the required levels and my bone marrow is not affected by my disease.I am living with HIV.I have eye problems like vision loss, color distortion, or blurry vision and need an eye exam.I've had a bone marrow biopsy to check for cancer if I had it there before.I am at high risk for cancer progression after CAR-T therapy due to one or more specific factors.I do not have an active infection that hasn't been treated.I have had a transplant from a donor.I do not have uncontrolled hepatitis B or C.My cancer has not spread to my brain, as confirmed by tests.I have a type of large B cell lymphoma and plan to be treated with Kymriah.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I have a history of heart failure or swelling in my lungs or legs.I haven't had a recent heart attack or severe chest pain.
Research Study Groups:
This trial has the following groups:- Group 1: Dose level 1 : E7777 at 5 mcg/kg
- Group 2: Dose level 1 : E7777 at 7 mcg/kg
- Group 3: Dose level 1 : E7777 at 9 mcg/kg
- Group 4: MTD from phase 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being signed up to participate in this research?
"The information available on clinicaltrials.gov seems to suggest that this particular study is still recruiting patients. This trial was first posted on June 9th 2021 and has since been updated on July 1st of 2022. They are looking for a total 30 subjects from a single site."
Answered by AI
How many people are being tested in this clinical trial at most?
"Yes, currently this study is still recruiting patients as indicated by recent updates on clinicaltrials.gov. The listing for the trial was created on 6/9/2021 and has been edited most recently on 7/1/2022. They are looking to enroll 30 patients at a single location."
Answered by AI
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