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NCT Number: NCT06470438

A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lymphoma, Non-Hodgkin Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Refractory B-Cell NHL Relapsed B-cell NHL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants have histologically or cytologically confirmed B-cell non-Hodgkin's Lymphoma (NHL) according to the 2022 World Health Organization (WHO) classification with relapsed or refractory disease
  • Participants have measurable disease or meet all requirements for adequate response assessment as defined by the appropriate disease response criteria at screening
  • Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Participants have a life expectancy of greater than or equal to (>=) 12 weeks
  • Be willing and able to adhere to the lifestyle restrictions specified in the protocol

Exclusion criteria

  • Participant with active or prior history of B-cell NHL involving the central nervous system (CNS) and leptomeningeal involvement
  • History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study treatment.
  • For Part A and B: Participant having known allergies, hypersensitivity, or intolerance to the excipients of JNJ-88998377
  • Participant had major surgery or had significant traumatic injury within 30 days before first dose of study treatment or has not recovered from surgery and must not have major surgery planned during the time the participant is receiving study treatment
  • Participant received an autologous stem cell transplant less than or equal to (<=) 3 months before the first dose of study treatment

Treatment and study plan

JNJ-88998377

Drug

JNJ-88998377 will be administered.

Primary outcomes

  1. Parts A and B: Number of Participants with Adverse Events (AEs)

    Time frame: Upto 3 years 4 months

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product.

  2. Part A: Number of Participants with Dose Limiting Toxicity (DLTs)

    Time frame: Cycle 1 (21 days)

    Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity.

Secondary outcomes

  1. Plasma Concentration of JNJ-88998377

    Time frame: Up to first 12 weeks

    Plasma concentration of oral dose of JNJ-88998377 will be assessed.

  2. Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377

    Time frame: Up to first 12 weeks

    Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported.

  3. Maximum Plasma Concentration (Cmax) of JNJ-88998377

    Time frame: Up to first 12 weeks

    Cmax of JNJ-88998377 will be reported.

  4. Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377

    Time frame: Up to first 12 weeks

    Cmin of JNJ-88998377 will be reported.

  5. Percentage of Participants With Overall Response (OR)

    Time frame: Up to 3 years 4 months

    OR is defined as the percentage of participants who have a best response of partial response (PR) or better per investigator assessment according to disease-specific response criteria.

  6. Time to Response (TTR)

    Time frame: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)

    TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better per investigator assessment according to disease-specific response criteria.

  7. Duration of Response (DOR)

    Time frame: From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)

    DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 24, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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