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A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer

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ClinicalTrials.gov Identifier: NCT06139406
Recruitment Status : Recruiting
First Posted : November 18, 2023
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs [Part B: Dose Expansion].

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: JNJ-87801493 Drug: JNJ-80948543 Drug: JNJ-75348780 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs)
Actual Study Start Date : December 6, 2023
Estimated Primary Completion Date : July 8, 2026
Estimated Study Completion Date : July 8, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose escalation
Participants will receive one cycle of TCE monotherapy (step up to target dose) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 one week later.
 Drug: JNJ-87801493
JNJ-87801493 will be administered subcutaneously.

Drug: JNJ-80948543
JNJ-80948543 will be administered subcutaneously.

Drug: JNJ-75348780
JNJ-75348780 will be administered subcutaneously.
Experimental: Part 2:Dose expansion
Participants with specific B-cell NHL histologies will receive recommended phase 2 regimen (RP2R) of JNJ-87801493 with TCE as determined in Part 1.
 Drug: JNJ-87801493
JNJ-87801493 will be administered subcutaneously.

Drug: JNJ-80948543
JNJ-80948543 will be administered subcutaneously.

Drug: JNJ-75348780
JNJ-75348780 will be administered subcutaneously.


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) [ Time Frame: Up to 2 years 7 months ]
    Number of participants with DLTs will be reported. The DLTs are specific adverse events and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity

  2. Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to 2 years 7 months ]
    An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: NCI-CTCAE grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and; American Society for Transplantation and Cellular Therapy (ASTCT) guidelines which is Grade 5 (death related to adverse event) Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]).


Secondary Outcome Measures :
  1. Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Up to 2 years 7 months ]
    Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.

  2. Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Up to 2 years 7 months ]
    AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).Area under the serum concentration curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.

  3. Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Up to 2 years 7 months ]
    Maximum observed serum concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.

  4. Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Up to 2 years 7 months ]
    Minimum observed serum concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.

  5. Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Up to 2 years 7 months ]
    Area under the curve from time zero to t (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.

  6. Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Up to 2 years 7 months ]
    Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.

  7. Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Up to 2 years 7 months ]
    Tmax is the time to reach maximum observed serum concentartion for JNJ-87801493, JNJ-80948543 and JNJ-75348780.

  8. Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Up to 2 years 7 months ]
    Apparent total body clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.

  9. Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Up to 2 years 7 months ]
    Apparent volume of distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.

  10. Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies [ Time Frame: Up to 2 years 7 months ]
    Number of participants with presence of antibodies binding to JNJ-87801493 or each combination partner (JNJ- 80948543 and JNJ-75348780).

  11. Overall Response as Assessed by the Investigator [ Time Frame: Up to 2 years 7 months ]
    Overall response is defined as a best response of partial response (PR) or better.

  12. Complete Response (CR) as Assessed by the Investigator [ Time Frame: Up to 2 years 7 months ]
    Complete response (CR) is defined as a best response of CR.

  13. Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator [ Time Frame: Up to 2 years 7 months ]
    Very good partial response (VGPR) is defined as a best response of VGPR or better.

  14. Time to Response (TTR) as Assessed by the Investigator [ Time Frame: Up to 2 years 7 months ]
    Time to response (TTR) is defined for participants who achieve a response of PR or better as the time from the first dose of any study drug to the first response of PR or better.

  15. Duration of Response (DOR) as Assessed by the Investigator [ Time Frame: Up to 2 years 7 months ]
    Duration of response (DOR) is defined for participants who achieved a response of PR or better as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death.


Eligibility Criteria
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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:

  • Histologic documentation of B-cell NHL. All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment
  • Part 1 and Part 2 participants must have either evaluable or measurable disease as defined by the appropriate disease response criteria
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
  • Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.

Exclusion Criteria:

  • Known active central nervous system involvement (CNS) or leptomeningeal involvement. CNS involvement may be allowed in specific cohorts as determined by the Study Evaluation Team (SET)
  • Prior solid-organ transplantation
  • Prior treatment with JNJ-80948543 and/or JNJ-75348780
  • Chemotherapy, targeted therapy, or immunotherapy within 14 days before the first dose of study treatment
  • Malignancy diagnosis other than the disease under study within 1 year prior to screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of the study drugs in the opinion of both the investigator and sponsor's medical monitor
  • Autoimmune or inflammatory disease requiring systemic corticosteroids or other immunosuppressive agents within 1 year prior to first dose of study treatment
  • Evidence of active viral, bacterial, or uncontrolled systemic fungal infection requiring systemic treatment within 7 days before the first dose of study treatment
  • Abnormal cardiac function
Contacts and Locations
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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): NCT06139406


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Australia
Linear Clinical Research Ltd Recruiting
Nedlands, Australia, 6009
Scientia Clinical Research Recruiting
Randwick, Australia, 2031
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Odense University Hospital Recruiting
Odense, Denmark, 5000
Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 9112001
Sourasky (Ichilov) Medical Center Recruiting
Tel Aviv, Israel, 6423906
Spain
Hosp. Univ. Fund. Jimenez Diaz Recruiting
Madrid, Spain, 28040
Clinica Univ. de Navarra Recruiting
Pamplona, Spain, 31008
Hosp. Clinico Univ. de Salamanca Recruiting
Salamanca, Spain, 37007
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT06139406    
Other Study ID Numbers: 87801493LYM1001
First Posted: November 18, 2023    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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