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

Lymphoma, Non-Hodgkin Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139406
• Other study ID #: 87801493LYM1001
• Secondary ID: 2023-505165-93-0
• Status: Recruiting
• Phase: Phase 1
• Start date: December 6, 2023
• Est. completion date: July 8, 2026

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 8, 2026
• Est. primary completion date: July 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ß)-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

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin

Intervention

Drug:
• JNJ-87801493
JNJ-87801493 will be administered subcutaneously.
• JNJ-80948543
JNJ-80948543 will be administered subcutaneously.
• JNJ-75348780
JNJ-75348780 will be administered subcutaneously.

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne
Australia	Linear Clinical Research Ltd	Nedlands
Australia	Scientia Clinical Research	Randwick
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
Israel	Hadassah Medical Center	Jerusalem
Israel	Sourasky (Ichilov) Medical Center	Tel Aviv
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp Univ Fund Jimenez Diaz	Madrid
Spain	Clinica Univ. de Navarra	Pamplona
Spain	Hosp Clinico Univ de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Australia,  Denmark,  Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)	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	Up to 2 years 7 months
Primary	Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity	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]).	Up to 2 years 7 months
Secondary	Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780	Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.	Up to 2 years 7 months
Secondary	Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780	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.	Up to 2 years 7 months
Secondary	Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780	Maximum observed serum concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.	Up to 2 years 7 months
Secondary	Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780	Minimum observed serum concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.	Up to 2 years 7 months
Secondary	Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780	Area under the curve from time zero to t (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.	Up to 2 years 7 months
Secondary	Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780	Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.	Up to 2 years 7 months
Secondary	Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780	Tmax is the time to reach maximum observed serum concentartion for JNJ-87801493, JNJ-80948543 and JNJ-75348780.	Up to 2 years 7 months
Secondary	Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780	Apparent total body clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.	Up to 2 years 7 months
Secondary	Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780	Apparent volume of distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.	Up to 2 years 7 months
Secondary	Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies	Number of participants with presence of antibodies binding to JNJ-87801493 or each combination partner (JNJ- 80948543 and JNJ-75348780).	Up to 2 years 7 months
Secondary	Overall Response as Assessed by the Investigator	Overall response is defined as a best response of partial response (PR) or better.	Up to 2 years 7 months
Secondary	Complete Response (CR) as Assessed by the Investigator	Complete response (CR) is defined as a best response of CR.	Up to 2 years 7 months
Secondary	Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator	Very good partial response (VGPR) is defined as a best response of VGPR or better.	Up to 2 years 7 months
Secondary	Time to Response (TTR) as Assessed by the Investigator	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.	Up to 2 years 7 months
Secondary	Duration of Response (DOR) as Assessed by the Investigator	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.	Up to 2 years 7 months