Informations générales (source: ClinicalTrials.gov)
A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL
Interventional
Phase 1
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
août 2022
novembre 2026
10 octobre 2024
The purpose of this study is to characterize safety and to determine the putative
recommended Phase 2 dose(s) (RP2D[s]), optimal dosing schedule(s) and route(s) of
administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize
the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:41 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Lille Hopital Claude Huriez - 59037 - Lille Cedex - France | Contact (sur clinicalTrials) | ||||
| Institut Universitaire du cancer de Toulouse-Oncopole - 31059 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic
lymphocytic leukemia (CLL) requiring therapy.
All participants must have relapsed or refractory disease with no other approved
therapies available that would be more appropriate in the investigator's judgment.
B-cell NHL as defined per the 2016 world health organization (WHO) classification. In
addition, the following disease-specific criteria outlined below must be met:
If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received,
or not eligible for high-dose chemotherapy and autologous stem cell transplantation with
curative intent or deemed not eligible or fit for an alternative 2nd line therapy.
Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell
treatment or while waiting for a CAR-T cell treatment.
If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate
for an approved first-line regimen for DLBCL and received or not eligible for high-dose
chemotherapy and autologous stem cell transplantation with curative intent.
If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior
lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody.
If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal,
extranodal/MALT, and splenic MZL subtypes): Previously treated with at least 2 lines of
systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H.
pylori eradication therapy as one of their prior lines .
Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic
therapy.
small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory
with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor
(BTK) inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants
must have measurable disease as defined by the appropriate disease response criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
- Cardiac parameters within the following range: corrected QT interval (QTc intervals
corrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480
milliseconds based on the average of triplicate assessments performed no more than 5
(plus minus [+-] 3) minutes apart
- A female participant of childbearing potential must have a negative highly sensitive
serum pregnancy test (beta- human chorionic gonadotropin) at screening and must
agree to further serum or urine pregnancy tests prior to the first dose, during the
study and until 3 months after the last dose of study treatment
- A female participant must agree not to be pregnant, breastfeeding, or planning to
become pregnant while enrolled in this study or within 3 months after the last dose
of study treatment
- Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic
lymphocytic leukemia (CLL) requiring therapy.
All participants must have relapsed or refractory disease with no other approved
therapies available that would be more appropriate in the investigator's judgment.
B-cell NHL as defined per the 2016 world health organization (WHO) classification. In
addition, the following disease-specific criteria outlined below must be met:
If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received,
or not eligible for high-dose chemotherapy and autologous stem cell transplantation with
curative intent or deemed not eligible or fit for an alternative 2nd line therapy.
Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell
treatment or while waiting for a CAR-T cell treatment.
If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate
for an approved first-line regimen for DLBCL and received or not eligible for high-dose
chemotherapy and autologous stem cell transplantation with curative intent.
If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior
lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody.
If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal,
extranodal/MALT, and splenic MZL subtypes): Previously treated with at least 2 lines of
systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H.
pylori eradication therapy as one of their prior lines .
Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic
therapy.
small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory
with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor
(BTK) inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants
must have measurable disease as defined by the appropriate disease response criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
- Cardiac parameters within the following range: corrected QT interval (QTc intervals
corrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480
milliseconds based on the average of triplicate assessments performed no more than 5
(plus minus [+-] 3) minutes apart
- A female participant of childbearing potential must have a negative highly sensitive
serum pregnancy test (beta- human chorionic gonadotropin) at screening and must
agree to further serum or urine pregnancy tests prior to the first dose, during the
study and until 3 months after the last dose of study treatment
- A female participant must agree not to be pregnant, breastfeeding, or planning to
become pregnant while enrolled in this study or within 3 months after the last dose
of study treatment
- Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement
may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if
approved by the study evaluation team (SET)
- Prior solid-organ transplantation
- Autoimmune or inflammatory disease requiring systemic steroids or other
immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior
to first dose of study drug
- Toxicity from prior anticancer therapy has not resolved to baseline levels or to
Grade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies
that are stable on hormone replacement, which may be Grade 2)
- Clinically significant pulmonary compromise, particularly the need for supplemental
oxygen use to maintain adequate oxygenation