COMPLETED

Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy

Conditions

Refractory Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified Recurrent Diffuse Large B-Cell Lymphoma Refractory High Grade B-Cell Lymphoma Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter Phase 1b study evaluating the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard of care CD19 CAR T-cell therapy for eligible subjects with r/r LBCL.

Official Title

A Phase 1b Study Evaluating the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa) a Long-acting Human IL-7, Post-Kymriah® (Tisagenlecleucel), Post-Yescarta® (Axicabtagene Ciloleucel), or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma

Quick Facts

Study Start:2021-08-06

Study Completion:2025-03-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05075603

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. In Dose Escalation phase: Grade ≥3 CRS or ICANS post-CD19 CAR T-cell infusion. Note: Grade 1 or 2 CRS or ICANs must be completely resolved \>3 days prior to NT-I7 injection 2. In Dose Expansion phase: Grade ≥3 CRS or ICANS post-CD19 CAR T-cell infusion. Note: Grade 1 or 2 CRS or ICANS must be completely resolved \>3 days prior to NT-I7 injection 3. Pregnant, lactating or breastfeeding or expecting to conceive or father children within the study duration from screening through 120 days after the last dose of study treatment. 4. This exclusion criteria has been removed and remains as a placeholder. 5. Subjects with documented current central nervous system (CNS) involvement by lymphoma are to be excluded from study participation. 6. Any concurrent chemotherapy or biologic or hormonal therapy for cancer treatment. 7. Subjects who have autoimmune disease history for the past 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following are exceptions to this criterion: 1. Subjects with vitiligo or alopecia. 2. Subjects with type 1 diabetes mellitus. 3. Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement 4. Psoriasis not requiring systemic treatment. 5. NOTE: Diverticulitis that is not associated with inflammatory bowel disease is not considered exclusionary (e.g., subjects who do not have active diarrhea due to chronic diverticulitis). 8. Have active and clinically relevant bacterial, fungal, viral, or TB infection, including known Hepatitis A, B, or C or HIV (testing not required). 9. Concurrent enrollment in another clinical study unless it is an observational (noninterventional) clinical study. 10. Receipt of any conventional or investigational anticancer therapy, not otherwise specified above, within 30 days prior to NT-I7 injection. 11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade ≤ 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss, peripheral neuropathy) after consultation with the medical monitor. 12. Receipt of live, attenuated vaccine within 30 days prior to NT-I7 injection. Note: Subjects, if enrolled, should not receive live vaccine during the study and through 30 days after NT-I7 injection, whichever is longer. The administration of killed vaccines is permitted at any time. 13. Has had an allogenic tissue/solid organ transplant or bone marrow transplant. 14. Subjects for whom intramuscular therapy is contraindicated. 15. Has clinically significant cardiac disease, including, but not limited to, any of the following: 1. Uncontrolled atrial fibrillation 2. Congestive Heart Failure NYHA Class ≥ 2 3. Or any of the following within 6 months prior to Baseline, Day 0 CAR-T administration: * Unstable angina * Myocardial infarction * Coronary artery bypass grafting * Coronary angioplasty * Coronary stenting * Clinically significant cardiac arrhythmia and/or conduction abnormality 4. History of other clinically significant cardiac disease that, in the opinion of the Investigator or designee, is a contraindication to study treatment is also excluded.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. In Dose Escalation phase: Grade ≥3 CRS or ICANS post-CD19 CAR T-cell infusion. Note: Grade 1 or 2 CRS or ICANs must be completely resolved \>3 days prior to NT-I7 injection
2. In Dose Expansion phase: Grade ≥3 CRS or ICANS post-CD19 CAR T-cell infusion. Note: Grade 1 or 2 CRS or ICANS must be completely resolved \>3 days prior to NT-I7 injection
3. Pregnant, lactating or breastfeeding or expecting to conceive or father children within the study duration from screening through 120 days after the last dose of study treatment.
4. This exclusion criteria has been removed and remains as a placeholder.
5. Subjects with documented current central nervous system (CNS) involvement by lymphoma are to be excluded from study participation.
6. Any concurrent chemotherapy or biologic or hormonal therapy for cancer treatment.
7. Subjects who have autoimmune disease history for the past 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following are exceptions to this criterion:
1. Subjects with vitiligo or alopecia.
2. Subjects with type 1 diabetes mellitus.
3. Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
4. Psoriasis not requiring systemic treatment.
5. NOTE: Diverticulitis that is not associated with inflammatory bowel disease is not considered exclusionary (e.g., subjects who do not have active diarrhea due to chronic diverticulitis).
8. Have active and clinically relevant bacterial, fungal, viral, or TB infection, including known Hepatitis A, B, or C or HIV (testing not required).
9. Concurrent enrollment in another clinical study unless it is an observational (noninterventional) clinical study.
10. Receipt of any conventional or investigational anticancer therapy, not otherwise specified above, within 30 days prior to NT-I7 injection.
11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade ≤ 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss, peripheral neuropathy) after consultation with the medical monitor.
12. Receipt of live, attenuated vaccine within 30 days prior to NT-I7 injection. Note: Subjects, if enrolled, should not receive live vaccine during the study and through 30 days after NT-I7 injection, whichever is longer. The administration of killed vaccines is permitted at any time.
13. Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
14. Subjects for whom intramuscular therapy is contraindicated.
15. Has clinically significant cardiac disease, including, but not limited to, any of the following:
1. Uncontrolled atrial fibrillation
2. Congestive Heart Failure NYHA Class ≥ 2
3. Or any of the following within 6 months prior to Baseline, Day 0 CAR-T administration:
* Unstable angina
* Myocardial infarction
* Coronary artery bypass grafting
* Coronary angioplasty
* Coronary stenting
* Clinically significant cardiac arrhythmia and/or conduction abnormality
4. History of other clinically significant cardiac disease that, in the opinion of the Investigator or designee, is a contraindication to study treatment is also excluded.

Contacts and Locations

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Detroit, Michigan, 48201

United States

Washington University in St. Louis

St Louis, Missouri, 63110

United States

Duke Cancer Institute

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: NeoImmuneTech

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-06

Study Completion Date2025-03-12

Study Record Updates

Study Start Date2021-08-06

Study Completion Date2025-03-12

Terms related to this study

Additional Relevant MeSH Terms

Refractory Diffuse Large B-cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Recurrent Diffuse Large B-Cell Lymphoma
Refractory High Grade B-Cell Lymphoma
Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma