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NT-I7 + CAR T-Cell Therapy for Large B-Cell Lymphoma
Phase 1
Recruiting
Research Sponsored by NeoImmuneTech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be ≥18 years on the day of signing informed consent
Subjects should be eligible for CAR-T therapy respective to the current FDA-approved CAR-T label for Yescarta, Breyanzi, or Kymriah
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and works well against large B-cell lymphoma that has come back or does not respond to treatment.
Who is the study for?
Adults over 18 with relapsed/refractory Large B-cell Lymphoma who've had at least two prior treatments and are eligible for CD19 CAR T-cell therapy. They must have an ECOG performance status of 0-1, measurable disease, a life expectancy of 12+ weeks, and adequate organ function. Exclusions include severe reactions to previous CAR T-cell therapy, pregnancy, CNS lymphoma involvement, active infections or concurrent clinical study participation.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of NT-I7 (Efineptakin alfa) given after standard CD19 CAR T-cell therapies like Axicabtagene ciloleucel, Lisocabtagene Maraleucel or Tisagenlecleucel in patients with r/r LBCL. It's a Phase 1b multicenter study focusing on how well patients tolerate this combination treatment.See study design
What are the potential side effects?
Potential side effects may include immune system reactions such as cytokine release syndrome (CRS), neurological events similar to those seen with other immunotherapies (ICANS), infection risks due to weakened immunity from the treatment, and typical infusion-related responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am eligible for CAR-T therapy as per FDA-approved guidelines.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My alkaline phosphatase levels are within the normal range, even with liver or bone issues.
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My organs and bone marrow are functioning well enough for chemotherapy before CAR T-cell therapy.
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I have a specific type of advanced lymphoma and am eligible for a special immune therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
For Dose Escalation Phase: Incidence of adverse events (AE)
Incidence of Dose Limiting Toxicities (DLT)
To determine the Maximum Tolerated Dose (MTD)
+1 moreSecondary outcome measures
Measurement of Duration of Response (DOR)
Measurement of Overall Survival (OS)
Measurement of Progression-Free Survival (PFS)
+4 moreOther outcome measures
Therapeutic procedure
Side effects data
From 2023 Phase 2 trial • 34 Patients • NCT0361072448%
Cytokine release syndrome
42%
Pyrexia
39%
Vomiting
33%
Anaemia
30%
Neutrophil count decreased
27%
Platelet count decreased
27%
Nausea
24%
White blood cell count decreased
24%
Headache
21%
Neutropenia
18%
Abdominal pain
15%
Leukopenia
15%
Alanine aminotransferase increased
15%
Fatigue
15%
Blood creatinine increased
15%
Cough
15%
Stomatitis
15%
Decreased appetite
15%
Hypokalaemia
12%
Tachycardia
12%
Chills
12%
Thrombocytopenia
12%
Hypomagnesaemia
12%
Epistaxis
9%
Diarrhoea
9%
Pleural effusion
9%
Lymphocyte count decreased
9%
Sinus tachycardia
9%
Constipation
9%
Catheter site pain
9%
Hypogammaglobulinaemia
9%
Weight decreased
9%
Hyperphosphataemia
9%
Hypertension
9%
Infusion related reaction
9%
Blood lactate dehydrogenase increased
9%
Paraesthesia
9%
Pruritus
6%
Generalised oedema
6%
Rash
6%
Neck pain
6%
Oedema peripheral
6%
Pain in extremity
6%
Depression
6%
Gastrooesophageal reflux disease
6%
Serum ferritin increased
6%
Neuralgia
6%
Blood bilirubin increased
6%
Febrile neutropenia
6%
Depressed level of consciousness
6%
Seizure
6%
Peripheral sensorimotor neuropathy
6%
Coagulopathy
6%
Dizziness
6%
Insomnia
6%
Neuropathy peripheral
6%
Anxiety
6%
Vision blurred
6%
Acute kidney injury
6%
Lymphopenia
6%
Lower gastrointestinal haemorrhage
6%
Small intestinal obstruction
6%
Cholelithiasis
6%
Bone marrow failure
6%
Abdominal pain upper
6%
Pain
6%
Myelitis
6%
SARS-CoV-2 test positive
6%
Drug hypersensitivity
6%
Hyponatraemia
6%
Hypophosphataemia
6%
Arthralgia
6%
Aspartate aminotransferase increased
6%
Dry skin
6%
Tachypnoea
6%
Alopecia
6%
Haematoma
6%
Hypotension
3%
Ejection fraction decreased
3%
Pneumothorax
3%
Respiratory distress
3%
Haemophagocytic lymphohistiocytosis
3%
Urinary tract infection
3%
Motor dysfunction
3%
Proctitis
3%
Hemiparesis
3%
Aspergillus infection
3%
Candida infection
3%
Condition aggravated
3%
Vascular device infection
3%
Disease progression
3%
Large intestinal obstruction
3%
Chest pain
3%
Cardiac arrest
3%
Pancreatitis
3%
Pseudomonas infection
3%
Dental caries
3%
Back pain
3%
Memory impairment
3%
Sepsis
3%
Aphasia
3%
Disturbance in attention
3%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tisagenlecleucel - Post-infusion
Tisagenlecleucel - Pre-infusion Deaths
Trial Design
1Treatment groups
Experimental Treatment
Group I: NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusionExperimental Treatment4 Interventions
CAR-T infusion administered per standard of care at Day 0 followed by NT-I7 on Day 21.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tisagenlecleucel
FDA approved
Find a Location
Who is running the clinical trial?
NeoImmuneTechLead Sponsor
10 Previous Clinical Trials
450 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot receive treatments by injection into my muscles.I am 18 years old or older.My lymphoma has not spread to my brain or spinal cord.My previously treated cancer area has grown and can be measured.I had severe reactions after a specific cancer treatment but they have resolved.I am eligible for CAR-T therapy as per FDA-approved guidelines.I haven't had cancer treatment in the last 30 days.My initial scans showed signs of cancer that match the tumor's location.My blood clotting tests are normal or within treatment range if I'm on blood thinners.I am fully active or restricted in physically strenuous activity but can do light work.I am a woman who cannot become pregnant or will avoid pregnancy during and after the study.My side effects from previous cancer treatments are mild, except for hair loss or specific lab values.I will need a new scan if my last one was over 28 days since my lymphodepletion therapy.I am not currently on any chemotherapy, biologic, or hormonal cancer treatments.I had bridging therapy before lymphodepletion and can join regardless of certain test results.I have had a transplant of an organ, tissue, or bone marrow from another person.I do not have serious heart problems.My alkaline phosphatase levels are within the normal range, even with liver or bone issues.I do not have any active infections like TB, Hepatitis, or HIV.My organs and bone marrow are functioning well enough for chemotherapy before CAR T-cell therapy.I have a specific type of advanced lymphoma and am eligible for a special immune therapy.I have not received a live vaccine within the last 30 days.I am a woman who can have children and have a recent negative pregnancy test.I haven't had any autoimmune diseases like lupus or MS in the last 2 years, except for conditions like vitiligo, type 1 diabetes, stable hypothyroidism, or psoriasis not needing systemic treatment.
Research Study Groups:
This trial has the following groups:- Group 1: NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Is this research new and innovative?
"At present, 16 live studies related to Tisagenlecleucel are taking place in 114 cities and 22 countries. Novartis Pharmaceuticals launched the first research into this drug back in 2015 with 115 participants completing Phase 2 of its approval process. Since then, a dozen further trials have been conducted."
Answered by AI
What risks are associated with utilization of Tisagenlecleucel?
"Due to a lack of data suggesting efficacy and safety, Tisagenlecleucel received the lowest score possible on our scale - one."
Answered by AI
How many participants are actively engaged in this trial?
"Confirmed. Clinicaltrials.gov indicates that this research study is actively recruiting participants, with an initial posting on August 6th 2021 and the most recent update occurring in August 9th 2022. This trial requires 57 patients from 3 distinct medical centres."
Answered by AI
Aside from the current research, what other experiments have been performed with Tisagenlecleucel?
"At present, 16 ongoing studies are assessing the efficacy of Tisagenlecleucel with two trials currently in their third phase. While most research is taking place within Badalona, Barcelona, a total of 296 locations have been enlisted to participate in clinical experiments regarding this drug."
Answered by AI
Are there any open enrollment spots for this clinical trial?
"Affirmative. Clinicaltrials.gov verifies that this medical trial is currently recruiting participants, which was initially posted on August 6th 2021 and last updated recently on August 9th 2022. The research team requires a total of 57 individuals to participate across 3 different sites."
Answered by AI
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