Refractory Diffuse Large B-cell LymphomaPhase 1NCT05075603

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

A Phase 1 study testing Efineptakin alfa, Tisagenlecleucel and Axicabtagene ciloleucel in people with Refractory Diffuse Large B-cell Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, run by NeoImmuneTech at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 chimeric antigen receptor T-cell (CAR T-cell) therapy for eligible subjects with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractory Diffuse Large B-cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma
What is being tested?: Efineptakin alfa, Tisagenlecleucel and Axicabtagene ciloleucel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 3 sitesUnited States
Study dates: 29 Jul 2021to 12 Mar 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

None listed.

Who cannot join

Subjects meeting any of the following criteria are not eligible for enrollment in the study:
In Dose Escalation phase: Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (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
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
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.
This exclusion criteria has been removed and remains as a placeholder.
Subjects with documented current central nervous system (CNS) involvement by lymphoma are to be excluded from study participation.

Show all 33Show fewer

Any concurrent chemotherapy or biologic or hormonal therapy for cancer treatment.
Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable. In addition, local treatment (e.g., by local surgery or radiotherapy) of isolated lesions for palliative intent is acceptable beyond the dose-limiting toxicity (DLT) evaluation period with prior consultation and agreement with the medical monitor.
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:
Subjects with vitiligo or alopecia.
Subjects with type 1 diabetes mellitus.
Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
Psoriasis not requiring systemic treatment.
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).
Have active and clinically relevant bacterial, fungal, viral, or TB infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required).
Concurrent enrollment in another clinical study unless it is an observational (noninterventional) clinical study.
Receipt of any conventional or investigational anticancer therapy, not otherwise specified above, within 30 days prior to NT-I7 injection.
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (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.
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.
Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
Subjects for whom intramuscular therapy is contraindicated.
Has clinically significant cardiac disease, including, but not limited to, any of the following:
Uncontrolled atrial fibrillation
Congestive Heart Failure New York Heart Association (NYHA) Class ≥2
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
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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

City of Hope
Duarte, California, 91010
Duke Cancer Institute
Durham, North Carolina, 27710
Washington University in St. Louis
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1b Study Evaluating the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 a Long-acting Human IL-7, Post-Kymriah®, Post-Yescarta®, or Post-Breyanzi® in Subjects With Relapsed/Refractory Large B-cell Lymphoma

Read the detailed 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. The study consists of a Dose Escalation phase followed by a Dose Expansion phase.

In the Dose Escalation phase, subjects will be enrolled in 1 of 7 dose levels, starting with 60 µg/kg and up to 720 µg/kg. A dose schedule for an individual dose level will not be taken into expansion until the Dose Escalation phase has been completed or a maximum tolerated dose (MTD) has been determined, whichever occurs first.

In the Dose Expansion phase, up to 15 subjects will be enrolled and treated with the recommended dose identified in the Dose Escalation phase.

Up to 17- 42 subjects in the Dose Escalation phase, and up to 15 subjects in the Dose Expansion phase will be enrolled at approximately 20 study centers.

Treatment Plan:

NT-I7 (aka rhIL-7-hyFc, efineptakin alpha), Tisagenlecleucel (Kymriah®), Axicabtagene ciloleucel (Yescarta®), Lisocabtagene Maraleucel (Breyanzi®)

*CAR-T Therapy will be administered per manufacturer's recommendations and in accordance with Food and Drug Administration (FDA) prescribing guidelines and best institutional practices for standard of care use.

Conditions: Refractory Diffuse Large B-cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma, DLBCL Arising From Follicular Lymphoma, Primary Mediastinal Large B-cell Lymphoma
Being tested: Efineptakin alfa, Tisagenlecleucel, Axicabtagene ciloleucel, Lisocabtagene Maraleucel
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.

Efineptakin alfaDrug
Also called NT-I7, rhIL-7-hyFc
NT-I7 is administered via an intramuscular injection after CAR-T infusion on Day 21.
TisagenlecleucelDrug
Also called Kymriah
Administered as standard of care as described in the package insert on Day 0.
Axicabtagene ciloleucelDrug
Also called Yescarta
Administered as standard of care as described in the package insert on Day 0.
Lisocabtagene MaraleucelDrug
Also called Breyanzi
Administered as standard of care as described in the package insert on Day 0.

Study groups in NCT05075603
Study group	Role	What they receive
NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion	Experimental	CAR-T infusion administered per standard of care at Day 0 followed by NT-I7 on Day 21. Receives: Drug: Efineptakin alfa; Drug: Tisagenlecleucel; Drug: Axicabtagene ciloleucel; Drug: Lisocabtagene Maraleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
Treatment-Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) with an onset date on or after NT-I7 administration and on or before Day 100. A serious TEAE is defined as any AE that resulted in any of the following outcomes: death; a life-threatening AE; an AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measured: From NT-I7 administration (Day 21) to Day 100
Incidence and Nature of DLTs
A Dose-Limiting Toxicity (DLT) is defined as any TEAE occurring within the first 21 days after NT-I7 administration that is considered to be at least possibly, probably, or definitely related to NT-I7 per the investigator, and that meets at least one of the protocol-defined non-hematologic or hematologic criteria.
Measured: From NT-I7 administration (Day 21) to Day 42
Potential Correlation of Dose Levels With Safety and Efficacy Parameters
The Recommended Phase 2 Dose (RP2D) was determined based on cumulative safety data and efficacy parameters (Objective Response Rate [ORR] and response rate at 6 months).
Measured: Up to 24 months

Secondary outcomes (4)

Measurement of Duration of Response (DoR)
Duration of Response (DoR) for the responders is defined as the time from the first occurrence of a documented objective response (Partial Response [PR] or Complete Response [CR]) to the time of the first documented disease progression or death from any cause, whichever occurs first, per the Lugano classification as determined by the investigator. Only participants with a response were assessed. The median DoR was estimated using a Kaplan-Meier method.
Measured: Up to 24 months
Measurement of Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from CAR T-cell administration to the first occurrence of disease progression or death from any cause, whichever occurs first. The Median PFS was estimated using the Kaplan-Meier method.
Measured: Up to 24 months
Measurement of Overall Survival (OS)
Overall Survival (OS) is defined as the time from CAR T-cell administration to death from any cause. The median OS was estimated using the Kaplan-Meier method.
Measured: Up to 24 months
Rates of Grade 3 and Higher Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
The Grades of Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) are assessed based on the American Society for Transplantation and Cellular Therapy (ASTCT).
Measured: From NT-I7 administration (Day 21) to Day 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 202112 Mar 2025

First posted13 Oct 2021
Study start29 Jul 2021
Primary completion18 Dec 2024
Study completion12 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Refractory Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05075603
Sponsor's protocol ID: NIT-112
Status last verified: Aug 2026
First submitted: 13 Sep 2021
Last updated: 10 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 1
Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
RecruitingPhase 1/2
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Active, not recruitingPhase 2
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All Refractory Diffuse Large B-cell Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b Study Evaluating the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 a Long-acting Human IL-7, Post-Kymriah®, Post-Yescarta®, or Post-Breyanzi® in Subjects With Relapsed/Refractory Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT05075603
Acronym / sponsor ID: NIT-112
Conditions: Refractory Diffuse Large B-cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma, DLBCL Arising From Follicular Lymphoma, Primary Mediastinal Large B-cell Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: NeoImmuneTechIndustry (pharma, biotech, devices)
Study start: 29 Jul 2021 (actual)
Primary completion: 18 Dec 2024 (actual)
Study completion: 12 Mar 2025 (actual)
First posted: 13 Oct 2021 (actual)
Results: Posted 10 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In the Dose Expansion phase, up to 15 subjects will be enrolled and treated with the recommended dose identified in the Dose Escalation phase.

Up to 17- 42 subjects in the Dose Escalation phase, and up to 15 subjects in the Dose Expansion phase will be enrolled at approximately 20 study centers.

Treatment Plan:

NT-I7 (aka rhIL-7-hyFc, efineptakin alpha), Tisagenlecleucel (Kymriah®), Axicabtagene ciloleucel (Yescarta®), Lisocabtagene Maraleucel (Breyanzi®)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion	Experimental	Drug: Efineptakin alfa, Drug: Tisagenlecleucel, Drug: Axicabtagene ciloleucel, Drug: Lisocabtagene MaraleucelCAR-T infusion administered per standard of care at Day 0 followed by NT-I7 on Day 21.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (33 listed)

Subjects meeting any of the following criteria are not eligible for enrollment in the study:
Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable. In addition, local treatment (e.g., by local surgery or radiotherapy) of isolated lesions for palliative intent is acceptable beyond the dose-limiting toxicity (DLT) evaluation period with prior consultation and agreement with the medical monitor.

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
Efineptakin alfaAlso: NT-I7, rhIL-7-hyFcNT-I7 is administered via an intramuscular injection after CAR-T infusion on Day 21.	Drug	NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion
TisagenlecleucelAlso: KymriahAdministered as standard of care as described in the package insert on Day 0.	Drug	NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion
Axicabtagene ciloleucelAlso: YescartaAdministered as standard of care as described in the package insert on Day 0.	Drug	NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion
Lisocabtagene MaraleucelAlso: BreyanziAdministered as standard of care as described in the package insert on Day 0.	Drug	NT-I7 after CAR-T (Kymriah, Yescarta, or Breyanzi) infusion

Primary outcome

Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
Time frame: From NT-I7 administration (Day 21) to Day 100
Treatment-Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) with an onset date on or after NT-I7 administration and on or before Day 100. A serious TEAE is defined as any AE that resulted in any of the following outcomes: death; a life-threatening AE; an AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Incidence and Nature of DLTs
Time frame: From NT-I7 administration (Day 21) to Day 42
A Dose-Limiting Toxicity (DLT) is defined as any TEAE occurring within the first 21 days after NT-I7 administration that is considered to be at least possibly, probably, or definitely related to NT-I7 per the investigator, and that meets at least one of the protocol-defined non-hematologic or hematologic criteria.
Potential Correlation of Dose Levels With Safety and Efficacy Parameters
Time frame: Up to 24 months
The Recommended Phase 2 Dose (RP2D) was determined based on cumulative safety data and efficacy parameters (Objective Response Rate [ORR] and response rate at 6 months).

4 secondary outcomes

Measurement of Duration of Response (DoR)
Time frame: Up to 24 months
Measurement of Progression-Free Survival (PFS)
Time frame: Up to 24 months
Measurement of Overall Survival (OS)
Time frame: Up to 24 months
Rates of Grade 3 and Higher Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time frame: From NT-I7 administration (Day 21) to Day 100

Results and safety

Results posted to the registry on 10 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Level 1: 60 µg/kg	1	1
Dose Level 2: 120 µg/kg	1	1
Dose Level 3: 240 µg/kg	3	3
Dose Level 4: 360 µg/kg	3	3
Dose Level 5: 480 µg/kg	3	3
Dose Level 6: 600 µg/kg	3	3
Dose Level 7: 720 µg/kg	3	3

Primary outcome: Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines

Time frame: From NT-I7 administration (Day 21) to Day 100. Count of participants. Unit: Participants

Measure	Dose Level 1: 60 µg/kg n = 1	Dose Level 2: 120 µg/kg n = 1	Dose Level 3: 240 µg/kg n = 3	Dose Level 4: 360 µg/kg n = 3	Dose Level 5: 480 µg/kg n = 3	Dose Level 6: 600 µg/kg n = 3	Dose Level 7: 720 µg/kg n = 3
Any TEAEs	1	1	3	3	2	3	3
TEAEs with Grade 3 or higher	0	1	2	0	0	1	1
TEAEs Related to NT-I7	1	1	1	2	1	0	2
NT-I7 Related TEAEs with Grade 3 or higher	0	0	0	0	0	0	0
TEAEs Related to CAR-T	0	0	0	1	1	3	2
CAR-T Related TEAEs with Grade 3 or higher	0	0	0	0	0	1	1
Any TEAEs Leading to Death	0	0	0	0	0	0	0
Any Serious TEAEs	0	0	0	1	0	0	1

Population analysed: Safety Population: All participants who received NT-I7 administration.

Primary outcome: Incidence and Nature of DLTs

Time frame: From NT-I7 administration (Day 21) to Day 42. Count of participants. Unit: Participants

Measure	Dose Level 1: 60 µg/kg n = 1	Dose Level 2: 120 µg/kg n = 1	Dose Level 3: 240 µg/kg n = 3	Dose Level 4: 360 µg/kg n = 3	Dose Level 5: 480 µg/kg n = 3	Dose Level 6: 600 µg/kg n = 3	Dose Level 7: 720 µg/kg n = 3
Value	0	0	0	0	0	0	0

Population analysed: DLT Population: all participants in the safety population who completed the full 3-week DLT period or who did not complete the full 3-week DLT period due to the occurrence of a DLT.

Primary outcome: Potential Correlation of Dose Levels With Safety and Efficacy Parameters

Time frame: Up to 24 months. Count of participants. Unit: Participants

Measure	Dose Level 1: 60 µg/kg n = 1	Dose Level 2: 120 µg/kg n = 1	Dose Level 3: 240 µg/kg n = 3	Dose Level 4: 360 µg/kg n = 3	Dose Level 5: 480 µg/kg n = 3	Dose Level 6: 600 µg/kg n = 3	Dose Level 7: 720 µg/kg n = 2
Overall Response Rate	0	1	3	2	3	3	2
Response Rate at 6 Months	0	0	1	0	2	3	2

Population analysed: Safety Population as all participants who received NT-I7 administration, and Per Protocol Population as all participants in the efficacy evaluable population who did not have any major protocol deviation. Per IWG response criteria for lymphoma (Lugano classification): Complete Response (CR), Score 1, 2, or 3 with or without a residual mass on 5PS; Partial Response (PR), Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Level 1: 60 µg/kg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Dose Level 2: 120 µg/kg	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Dose Level 3: 240 µg/kg	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Dose Level 4: 360 µg/kg	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Dose Level 5: 480 µg/kg	0 of 3 (0%)	2 of 3 (66.7%)	1 of 3
Dose Level 6: 600 µg/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Dose Level 7: 720 µg/kg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

John DiPersio, M.D. principal investigator

Washington University School of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 0 inclusion and 33 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: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines (time frame: From NT-I7 administration (Day 21) to Day 100). The study lists 3 primary outcomes in all. 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 NCT05075603.

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 10 Aug 2026.