Etude : 75348780LYM1001 /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : 75348780LYM1001

Situation thérapeutique : Induction

Traitement : Immunothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 30/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants With NHL and CLL

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C85 - Lymphome non hodgkinien, de types autres et non précisés

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C91 - Leucémie lymphoïde
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : STUDY DESIGN:
The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of JNJ-75348780 in participants with relapsed/ refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) in Part A and to further characterize the safety at the RP2D(s) in Part B.
B-cell lymphoid malignancies include CLL and NHL and are defined by clonal populations of B-lymphocytes expressing identical surface antigens. CD22 is a surface protein specifically expressed on B-lymphocytes and is expressed in B-lymphocytic malignancies. It is known to negatively regulate the B-cell receptor via its cytosolic immunoreceptor tyrosine-based inhibitory motifs. JNJ-75348780 is a novel human bispecific antibody that recognizes the CD3 antigen on T-lymphocytes and the CD22 antigen on mature and malignant B-lymphocytes. JNJ-75348780 is hypothesized to lead to cytotoxicity, T-cell activation and induction of cytokines upon engagement of CD3 on T-cells and CD22 on malignant B-lymphocytes. The study consists of screening phase, treatment phase and post-treatment phase. The total study duration will be up to 2.7 years. Efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy or colonoscopy, physical examinations. Safety will be monitored throughout the study.

STUDY ARMS:
- Experimental: Part A: Dose Escalation
Participants will receive weekly administration of JNJ-75348780. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET), along to the potential exploration of other routes of administration and schedules, until one or more recommended Phase 2 Doses (RP2D) have been identified.
Participants will receive JNJ-75348780 by intravenous (IV) or subcutaneous (SC) administration

- Experimental: Part B: Cohort Expansion
Participants will receive JNJ-75348780 at one of the putative RP2Ds determined in Part A.

CURRENT PRIMARY OUTCOMES:
- Part A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 2.7 years ]
- Part A and Part B: Number of Participants with AEs by Severity [ Time Frame: Up to 2.7 years ]
- Part A and Part B: Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 14 days ]

CURRENT SECONDARY OUTCOMES:
- Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-75348780 [ Time Frame: Up to 2.7 years ]
- Maximum Observed Serum Concentration (Cmax) of JNJ-75348780 [ Time Frame: Predose, 48 hours postdose (up to 2.7 years) ]
- Minimum Observed Serum Concentration (Cmin) of JNJ-75348780 [ Time Frame: Predose, 48 hours postdose (up to 2.7 years) ]
- Objective Response Rate (ORR) [ Time Frame: Up to 2.7 years ]
- Complete Response (CR) Rate [ Time Frame: Up to 2.7 years ]
- Time to Response (TTR) [ Time Frame: Up to 2.7 years ]
- Duration of Response (DOR) [ Time Frame: Up to 2.7 years ]

Phase : I

Stade : NA

Rechute, Réfractaire
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologic documentation of disease: B-cell NHL or CLL requiring therapy;
B-cell NHL: all participants must have relapsed or refractory disease. In addition, the following disease-specific criteria outlined below must be met
a) If diffuse large B-cell lymphoma (DLBCL): received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent,
b) If follicular lymphoma (FL)/ marginal zone lymphoma (MZL) (except mucosa-associated lymphoid tissue [MALT]), or Waldenstrom macroglobulinemia (WM): previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody,
c) If mantle cell lymphoma (MCL): previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody.

CLL or small lymphocytic lymphoma (SLL): relapsed or refractory with at least 1 prior line of systemic therapy containing a bruton tyrosine kinase inhibitor (BTKi)

and 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 (ms) based on the average of triplicate assessments performed no more than 5 plus minus (+ - 3) minutes apart
- Women of childbearing potential must have a negative highly sensitive serum (Beta human chorionic gonadotropin) at screening and prior to the first dose of study drug
- Women must be:
a) not of childbearing potential,
b) of childbearing potential and practicing a highly effective, preferably user independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 90 days after last dose

Critères de non-inclusion : - Known active central nervous system (CNS) involvement with lymphoma
- Prior solid-organ transplantation
- Either of the following:
a) received an autologous stem cell transplant <=3 months before the first dose of JNJ 75348780,
b) prior treatment with allogenic stem cell transplant <= 6 months before the first dose of JNJ-75348780, has evidence of graft versus host disease, or requires immunosuppressant therapy
- Prior chemotherapy, targeted therapy, immunotherapy, radiotherapy (with the exclusion of palliative radiation to limited sites that do not interfere with response assessment based on a sufficient number of other sites), or treatment with an investigational anticancer agent or an investigational drug (including investigational vaccines) within 2 weeks before the first administration of study drug. 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
- Active autoimmune disease that requires systemic immunosuppressive medications (example, chronic corticosteroid, methotrexate, or tacrolimus)
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04540796
Promoteur :
JANSSEN
Type de sponsor : Industriel
JANSSEN - JANSSEN
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Franck MORSCHHAUSER

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : OUVERT

MAJ : 22/02/2021