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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 below
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I am 18 years old or older.
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I am eligible for CAR-T therapy as per FDA-approved guidelines.
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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 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

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 more
Secondary outcome measures
Measurement of Duration of Response (DOR)
Measurement of Overall Survival (OS)
Measurement of Progression-Free Survival (PFS)
+4 more
Other outcome measures
Therapeutic procedure

Side effects data

From 2022 Phase 2 trial • 115 Patients • NCT02445248
48%
Anaemia
41%
Cytokine release syndrome
36%
White blood cell count decreased
35%
Neutrophil count decreased
33%
Platelet count decreased
31%
Diarrhoea
30%
Pyrexia
29%
Nausea
24%
Fatigue
24%
Hypotension
23%
Hypokalaemia
21%
Headache
18%
Neutropenia
17%
Constipation
17%
Hypomagnesaemia
17%
Hypophosphataemia
17%
Cough
15%
Oedema peripheral
14%
Arthralgia
14%
Dyspnoea
13%
Decreased appetite
13%
Thrombocytopenia
13%
Upper respiratory tract infection
12%
Chills
12%
Dizziness
12%
Weight decreased
10%
Febrile neutropenia
10%
Tachycardia
10%
Blood creatinine increased
10%
Anxiety
9%
Urinary tract infection
9%
Pain in extremity
9%
Hypogammaglobulinaemia
8%
Abdominal pain
8%
Hyponatraemia
8%
Vomiting
8%
Influenza like illness
8%
Nasopharyngitis
8%
Pneumonia
7%
Insomnia
7%
Asthenia
7%
Sinusitis
7%
Confusional state
7%
Hypoxia
6%
Back pain
6%
Stomatitis
6%
Influenza
6%
Blood immunoglobulin G decreased
6%
Lymphocyte count decreased
6%
Myalgia
5%
Dry mouth
5%
Pain
5%
Hypocalcaemia
5%
Acute kidney injury
5%
Pleural effusion
5%
Rash
5%
Oropharyngeal pain
5%
Night sweats
3%
Myelodysplastic syndrome
3%
Prostate cancer
3%
Multiple organ dysfunction syndrome
3%
Clostridium difficile infection
3%
Sepsis
3%
Encephalopathy
3%
Pancytopenia
2%
Bone marrow failure
2%
Gastrointestinal haemorrhage
2%
Infection
2%
Respiratory tract infection
2%
Staphylococcal infection
2%
Dehydration
2%
Respiratory failure
2%
Pneumocystis jirovecii pneumonia
2%
Pulmonary embolism
1%
Haemophagocytic lymphohistiocytosis
1%
Syncope
1%
Urosepsis
1%
C-reactive protein increased
1%
Hepatic failure
1%
Bronchopulmonary aspergillosis
1%
Polyarthritis
1%
Pulmonary haemorrhage
1%
Lymphadenopathy
1%
Acute myeloid leukaemia
1%
Atrial fibrillation
1%
Cardiac arrest
1%
Cardiac failure congestive
1%
Cardio-respiratory arrest
1%
Cardiopulmonary failure
1%
Vertigo
1%
Anal fissure
1%
Duodenal ulcer haemorrhage
1%
Haematemesis
1%
Large intestinal obstruction
1%
Melaena
1%
Pancreatitis acute
1%
Face oedema
1%
Cholecystitis acute
1%
Atypical pneumonia
1%
Bronchitis
1%
Candida infection
1%
Cerebral toxoplasmosis
1%
Corynebacterium infection
1%
Escherichia infection
1%
Lower respiratory tract infection
1%
Systemic infection
1%
Vaginal infection
1%
Blood bilirubin increased
1%
Liver function test increased
1%
Hypercalcaemia
1%
Tumour lysis syndrome
1%
Acute polyneuropathy
1%
Cerebral haemorrhage
1%
Demyelinating polyneuropathy
1%
Ischaemic cerebral infarction
1%
Metabolic encephalopathy
1%
Somnolence
1%
Status epilepticus
1%
Mental status changes
1%
Chronic kidney disease
1%
Urinary tract obstruction
1%
Allergic bronchitis
1%
Asphyxia
1%
Pneumonitis
1%
Deep vein thrombosis
1%
Neuroendocrine carcinoma
1%
Upper limb fracture
1%
Refractory cytopenia with multilineage dysplasia
1%
Pharyngeal haemorrhage
1%
Myopathy
1%
Tumour haemorrhage
1%
Pneumonia aspiration
1%
Pseudomonas infection
1%
Tumour associated fever
1%
Invasive ductal breast carcinoma
1%
Malignant melanoma
1%
Cystitis haemorrhagic
1%
Infusion related reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tisagenlecleucel - All Patients

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

Tisagenlecleucel Clinical Trial Eligibility Overview. Trial Name: NCT05075603 — Phase 1
Diffuse Large B-Cell Lymphoma Research Study Groups: NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Tisagenlecleucel Highlights & Side Effects. Trial Name: NCT05075603 — Phase 1
Tisagenlecleucel 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075603 — Phase 1

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
Recent research and studies
clinicaltrials.govStudy
Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy
2021. "Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05075603.
~7 spots leftby Nov 2024
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