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NCT05075603
Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy
Phase 1 trial testing Efineptakin alfa in Refractory Diffuse Large B-cell Lymphoma in 17 participants. Completed in 12 March 2025.
18 December 2024
Quick facts
| Lead sponsor | NeoImmuneTech |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 6 August 2021 |
| Primary completion | 18 December 2024 |
| Estimated completion | 12 March 2025 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Efineptakin alfa — full drug profile →
- Tisagenlecleucel (TISAGENLECLEUCEL) — full drug profile →
- Axicabtagene ciloleucel — full drug profile →
- Lisocabtagene Maraleucel (LISOCABTAGENE MARALEUCEL) — full drug profile →
Conditions studied
- Refractory Diffuse Large B-cell Lymphoma — all drugs for Refractory Diffuse Large B-cell Lymphoma →
- Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified — all drugs for Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified →
- Recurrent Diffuse Large B-Cell Lymphoma — all drugs for Recurrent Diffuse Large B-Cell Lymphoma →
- Refractory High Grade B-Cell Lymphoma — all drugs for Refractory High Grade B-Cell Lymphoma →
Sponsor
NeoImmuneTech — full company profile →
Who can join
18 and older, any sex, with Refractory Diffuse Large B-cell Lymphoma or Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Nanodelivery of nucleic acids.
Mendes BB, Conniot J, Avital A, Yao D, et al · · 2022 · cited 401× · PMID 35480987 · DOI 10.1038/s43586-022-00104-y -
CAR-T cell therapy for cancer: current challenges and future directions.
Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w -
The Role of IL-7 and IL-7R in Cancer Pathophysiology and Immunotherapy.
Wang C, Kong L, Kim S, Lee S, et al · · 2022 · cited 78× · PMID 36142322 · DOI 10.3390/ijms231810412 -
A long-acting interleukin-7, rhIL-7-hyFc, enhances CAR T cell expansion, persistence, and anti-tumor activity.
Kim MY, Jayasinghe R, Devenport JM, Ritchey JK, et al · · 2022 · cited 77× · PMID 35697686 · DOI 10.1038/s41467-022-30860-0 -
The application of Interleukin-2 family cytokines in tumor immunotherapy research.
Zhou Y, Quan G, Liu Y, Shi N, et al · · 2023 · cited 32× · PMID 36936961 · DOI 10.3389/fimmu.2023.1090311 -
An "off-the-shelf" CD2 universal CAR-T therapy for T-cell malignancies.
Xiang J, Devenport JM, Carter AJ, Staser KW, et al · · 2023 · cited 29× · PMID 37798328 · DOI 10.1038/s41375-023-02039-z -
Anti-myeloma efficacy of CAR-iNKT is enhanced with a long-acting IL-7, rhIL-7-hyFc.
O'Neal J, Cooper ML, Ritchey JK, Gladney S, et al · · 2023 · cited 22× · PMID 37399471 · DOI 10.1182/bloodadvances.2023010032 -
Combination strategies to optimize the efficacy of chimeric antigen receptor T cell therapy in haematological malignancies.
Xiao X, Wang Y, Zou Z, Yang Y, et al · · 2022 · cited 20× · PMID 36091028 · DOI 10.3389/fimmu.2022.954235
Verify or expand the search:
- PubMed search for NCT05075603
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Efineptakin alfa
Trials testing the same drug.
- NCT05465954 — Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma · Phase 2 · recruiting
- NCT04893018 — NT-I7 for Kaposi Sarcoma in Patients With or Without HIV · Phase 1 · terminated
- NCT04588038 — NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery · Phase 1 · terminated
Other recruiting trials for Refractory Diffuse Large B-cell Lymphoma
Currently open trials in the same condition.
- NCT06047197 — Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma · Phase 1 · recruiting
Other NeoImmuneTech trials
Trials by the same sponsor.
- NCT04594811 — NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma · Phase 1 · terminated
- NCT04501796 — A Trial of NT-I7 in COVID-19 (SPESELPIS) · Phase 1 · terminated
- NCT04332653 — NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors · Phase 1, PHASE2 · completed
- NCT03901573 — High-Risk Skin Cancers With Atezolizumab Plus NT-I7 · Phase 1, PHASE2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05075603 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NeoImmuneTech
- Last refreshed: 23 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05075603.
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