En studie av JNJ-87801493 i kombinasjon med T-celle-engasjerte hos deltakere med B-celle non-Hodgkin lymfoid (NHL) kreft
En fase 1, første-i-menneske-studie av JNJ-87801493 i kombinasjon med CD3-t-celle-engagerer hos deltakere med tilbakefall/refraktær B-celle non-Hodgkin lymfoide maligniteter (NHL)
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].
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Heidelberg, Australia, 3084
- Austin Hospital
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Melbourne, Australia, 3004
- The Alfred Hospital
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Nedlands, Australia, 6009
- Linear Clinical Research Ltd
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Randwick, Australia, 2031
- Scientia Clinical Research
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Copenhagen, Danmark, DK-2100
- Rigshospitalet
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Odense, Danmark, 5000
- Odense University Hospital
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Jerusalem, Israel, 9112001
- Hadassah Medical Center
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Tel Aviv, Israel, 6423906
- Sourasky (Ichilov) Medical Center
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Barcelona, Spania, 08035
- Hosp Univ Vall D Hebron
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Madrid, Spania, 28040
- Hosp Univ Fund Jimenez Diaz
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Pamplona, Spania, 31008
- Clinica Univ. de Navarra
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Salamanca, Spania, 37007
- Hosp Clinico Univ de Salamanca
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologic documentation of B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLBCL) or other high-grade B cell lymphoma and participants with transformed lymphoma from low-grade B cell malignancies who relapsed or failed to respond to only one prior systemic treatment regimen can be included
- Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease; all as defined by the Lugano criteria for non-Hodgkin lymphoid malignancies (NHL) and the international workshop on Waldenstrom's Macroglobulinemia (IWWM-6) for WM
- 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 2 weeks 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Part 1: Dose escalation
Participants will receive one cycle of TCE monotherapy (step up dosing) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 at least one week later. |
JNJ-87801493 will be administered subcutaneously. JNJ-80948543 will be administered subcutaneously. JNJ-75348780 will be administered subcutaneously. |
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Eksperimentell: 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. |
JNJ-87801493 will be administered subcutaneously. JNJ-80948543 will be administered subcutaneously. JNJ-75348780 will be administered subcutaneously. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
Tidsramme: Up to 2 years 7 months
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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
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Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity
Tidsramme: Up to 2 years 7 months
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tidsramme: Up to 2 years 7 months
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Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
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Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tidsramme: Up to 2 years 7 months
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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
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Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tidsramme: Up to 2 years 7 months
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Maximum observed serum concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
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Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tidsramme: Up to 2 years 7 months
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Minimum observed serum concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
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Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tidsramme: Up to 2 years 7 months
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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
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Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tidsramme: Up to 2 years 7 months
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Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
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Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tidsramme: Up to 2 years 7 months
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Tmax is the time to reach maximum observed serum concentartion for JNJ-87801493, JNJ-80948543 and JNJ-75348780. |
Up to 2 years 7 months
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Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tidsramme: Up to 2 years 7 months
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Apparent total body clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
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Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tidsramme: Up to 2 years 7 months
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Apparent volume of distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported. |
Up to 2 years 7 months
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Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies
Tidsramme: Up to 2 years 7 months
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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
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Overall Response as Assessed by the Investigator
Tidsramme: Up to 2 years 7 months
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Overall response is defined as a best response of partial response (PR) or better. |
Up to 2 years 7 months
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Complete Response (CR) as Assessed by the Investigator
Tidsramme: Up to 2 years 7 months
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Complete response (CR) is defined as a best response of CR. |
Up to 2 years 7 months
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Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator
Tidsramme: Up to 2 years 7 months
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Very good partial response (VGPR) or better is defined as a best response of VGPR or better. |
Up to 2 years 7 months
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Time to Response (TTR) as Assessed by the Investigator
Tidsramme: Up to 2 years 7 months
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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
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Duration of Response (DOR) as Assessed by the Investigator
Tidsramme: Up to 2 years 7 months
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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
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 87801493LYM1001
- 87801493LYM1001 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-505165-93-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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
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