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A Study to Evaluate the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa) Post-Tisagenlecleucel (Kymriah®) in Relapsed/Refractory Large B-cell Lymphoma Subjects

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ClinicalTrials.gov Identifier: NCT05075603
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
NeoImmuneTech

Brief Summary:
This is 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-Tisagenlecleucel (Kymriah®) in subjects with relapsed/refractory large B-cell Lymphoma.

Condition or disease Intervention/treatment Phase
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 Drug: Tisagenlecleucel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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-Tisagenlecleucel (Kymriah®) in Subjects With Relapsed/Refractory Large B-cell Lymphoma
Actual Study Start Date : August 6, 2021
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : February 2026


Arm Intervention/treatment
Experimental: Single Arm
Drug: NT-I7 (efineptakin alfa)
Drug: Tisagenlecleucel
NT-I7 is administered via intramuscular injection 21 days after Kymriah® infusion
Other Name: Kymriah®




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of NT-I7 when administered after Kymriah infusion [ Time Frame: Up to 21 days ]
    Incidence of adverse events graded according to NCI CTCAE v5.0

  2. To evaluate the safety and tolerability of NT-I7 when administered after Kymriah infusion [ Time Frame: Up to 21 days ]
    nature of adverse events graded according to NCI CTCAE v5.0

  3. To evaluate the safety and tolerability of NT-I7 when administered after Kymriah infusion [ Time Frame: Up to 21 days ]
    Severity of adverse events graded according to NCI CTCAE v5.0

  4. To determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7 when administered after Kymriah infusion [ Time Frame: Up to 21 days ]
    Incidence of DLTs

  5. To determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 To determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7 when administered after Kymriah infusion [ Time Frame: Up to 21 days ]
    Nature of DTLs

  6. To determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 To determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7 when administered after Kymriah infusion [ Time Frame: Up to 21 days ]
    Potential correlation of dose levels with safety and efficacy parameters


Secondary Outcome Measures :
  1. To explore the preliminary anti-tumor activity of NT-I7 when administered after Kymriah infusion for r/r LBCL [ Time Frame: Up to 3 months ]
    Overall Response Rate (ORR)

  2. To explore the preliminary anti-tumor activity of NT-I7 when administered after Kymriah infusion for r/r LBCL [ Time Frame: Up to 3 months ]
    Duration of Response

  3. To explore the preliminary anti-tumor activity of NT-I7 when administered after Kymriah infusion for r/r LBCL [ Time Frame: Up to 3 months ]
    Progression -Free Survival (PFS)

  4. To explore the preliminary anti-tumor activity of NT-I7 when administered after Kymriah infusion for r/r LBCL [ Time Frame: Up to 3 months ]
    Overall Survival (OS)

  5. To continue evaluating the effect of NT-I7 when administered after Kymriah infusion on safety profile [ Time Frame: Up to 3 months ]
    Rates of grade 3 and higher Cytokine Release Syndrome (CRS)

  6. To continue evaluating the effect of NT-I7 when administered after Kymriah infusion on safety profile [ Time Frame: Up to 3 months ]
    Rates of grade 3 and higher Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)


Other Outcome Measures:
  1. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Parameters of expansion

  2. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Parameters of maximum concentration (Cmax)

  3. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Parameters of time to maximum concentration (Tmax)

  4. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Parameters of persistence

  5. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Parameters of terminal half-life (T1/2)

  6. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Parameters of last measured concentration (Clast)

  7. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Parameters of time of last measured concentration (Tlast)

  8. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Area under the curve for CAR T-cell expansion for days 0-21 (prior to NT-I7 administration)

  9. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Area under the curve for days 22-90 (after NT-I7 administration)

  10. To make a preliminary assessment of PK parameters of Kymriah when administered NT-I7 post- Tisagenlecleucel therapy [ Time Frame: Up to 3 months ]
    Area under the curve for days 22-90 ( 3 months post Kymriah infusion)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be ≥18 years on the day of signing informed consent.
  2. Be willing and able to provide written informed consent/assent for the study.
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  4. Have received at least 2 prior lines of therapy and must be eligible for Kymriah therapy as SOC
  5. Subjects with relapsed or refractory LBCL after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), high grade B-cell lymphoma , and DLBCL arising from follicular lymphoma, must be eligible for Kymriah therapy as SOC.
  6. Subjects must have measurable disease by IWG response criteria for lymphoma [Lugano classification (1)]
  7. All subjects must consent to biopsies
  8. Subjects must have a life expectancy of greater than or equal to 12 weeks per assessment from the enrolling physician.
  9. Adequate organ and marrow function at the start of lymphodepleting chemotherapy as pre-conditioning for Kymriah infusion

Exclusion Criteria:

  1. In Dose Escalation phase: Grade ≥2 CRS or ICANS post-Kymriah infusion.
  2. In Dose Expansion phase: Grade ≥3 CRS or ICANS post-Kymriah infusion.
  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. Had previously received CD19-directed therapy
  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.
  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 (non interventional) 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
  12. Receipt of live, attenuated vaccine within 30 days prior to NT-I7 injection.
  13. Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
  14. Subjects for whom intramuscular therapy is contraindicated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075603


Contacts
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Contact: Kristina Stermer, MMS 301-944-0183 kstermer@neoimmunetech.com
Contact: Helena Holsey, MS hholsey@neoimmunetech.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Elizabeth Budde, MD, PhD         
Principal Investigator: Elizabeth Budde, MD, PhD         
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Armin Ghobadi, MD         
Principal Investigator: Armin Ghobadi, MD         
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Ahmed Galal, MD         
Sponsors and Collaborators
NeoImmuneTech
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Responsible Party: NeoImmuneTech
ClinicalTrials.gov Identifier: NCT05075603    
Other Study ID Numbers: NIT-112
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin