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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06139406
Recruitment Status : Recruiting
First Posted : November 18, 2023
Last Update Posted : May 13, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE November 15, 2023
First Posted Date  ICMJE November 18, 2023
Last Update Posted Date May 13, 2024
Actual Study Start Date  ICMJE December 6, 2023
Estimated Primary Completion Date July 8, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2024)
  • 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 drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity
  • 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]).
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2023)
  • 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
  • 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]).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2023)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2023)
  • Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
  • Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    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.
  • Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    Maximum observed serum concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
  • Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    Minimum observed serum concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
  • Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    Area under the curve from time zero to t (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
  • Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
  • Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    Tmax is the time to reach maximum observed serum concentartion for JNJ-87801493, JNJ-80948543 and JNJ-75348780.
  • Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    Apparent total body clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
  • Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    Apparent volume of distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
  • Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies [ Time Frame: Pre-dose, up to 168 hours post dose on Day 1 ]
    Number of participants with presence of antibodies binding to JNJ-87801493 or each combination partner (JNJ- 80948543 and JNJ-75348780).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer
Official Title  ICMJE 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)
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].
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Non-Hodgkin
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: JNJ-87801493
    • Drug: JNJ-80948543
    • Drug: JNJ-75348780
  • 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.
    Interventions:
    • Drug: JNJ-87801493
    • Drug: JNJ-80948543
    • Drug: JNJ-75348780
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2023)		 70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 8, 2026
Estimated Primary Completion Date July 8, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease;all 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. In addition, history of known allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or JNJ-87801493 or its excipients
  • Chemotherapy, targeted therapy, or immunotherapy within 14 days before the first dose of study treatment. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives. For checkpoint blockade therapy (example, anti-programmed cell death protein-1 [anti-PD-1]), a washout period of up to 6 weeks may be considered
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com
Listed Location Countries  ICMJE Australia,   Denmark,   Israel,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06139406
Other Study ID Numbers  ICMJE 87801493LYM1001
2023-505165-93-00 ( Registry Identifier: EUCT number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Janssen Research & Development, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Janssen Research & Development, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP