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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04540796




Registration number
NCT04540796
Ethics application status
Date submitted
2/09/2020
Date registered
7/09/2020
Date last updated
23/04/2021

Titles & IDs
Public title
A Study of JNJ-75348780 in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
Scientific title
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
Secondary ID [1] 0 0
2020-001183-29
Secondary ID [2] 0 0
CR108882
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Non-Hodgkin 0 0
Leukemia, Lymphocytic, Chronic, B-Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-75348780

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.

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


Treatment: Drugs: JNJ-75348780
Participants will receive JNJ-75348780 by intravenous (IV) or subcutaneous (SC) administration.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability - An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Timepoint [1] 0 0
Up to 2.7 years
Primary outcome [2] 0 0
Part A and Part B: Number of Participants with AEs by Severity - Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Timepoint [2] 0 0
Up to 2.7 years
Primary outcome [3] 0 0
Part A and Part B: Number of Participants with Dose-Limiting Toxicity (DLT) - Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Timepoint [3] 0 0
Up to 14 days
Secondary outcome [1] 0 0
Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-75348780 - AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.
Timepoint [1] 0 0
Up to 2.7 years
Secondary outcome [2] 0 0
Maximum Observed Serum Concentration (Cmax) of JNJ-75348780 - Cmax is the maximum observed serum concentration of JNJ-75348780.
Timepoint [2] 0 0
Predose, 48 hours postdose (up to 2.7 years)
Secondary outcome [3] 0 0
Minimum Observed Serum Concentration (Cmin) of JNJ-75348780 - Cmin is the minimum observed serum concentration of JNJ-75348780.
Timepoint [3] 0 0
Predose, 48 hours postdose (up to 2.7 years)
Secondary outcome [4] 0 0
Objective Response Rate (ORR) - ORR is defined as the percentage of participants who achieve a complete response (CR) and partial response (PR) or better according to the revised response criteria for malignant lymphoma, the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) response criteria and International Workshop for Waldenstrom Macroglobulinemia (IWWM) response criteria.
Timepoint [4] 0 0
Up to 2.7 years
Secondary outcome [5] 0 0
Complete Response (CR) Rate - CR rate is defined as the percentage of participants who achieve a best response of CR according to the revised response criteria for malignant lymphoma, iwCLL response criteria and IWWM response criteria.
Timepoint [5] 0 0
Up to 2.7 years
Secondary outcome [6] 0 0
Time to Response (TTR) - TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR according to the revised response criteria for malignant lymphoma, iwCLL response criteria and IWWM response criteria.
Timepoint [6] 0 0
Up to 2.7 years
Secondary outcome [7] 0 0
Duration of Response (DOR) - DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of either the first documented evidence of disease progression or death according to the revised response criteria for malignant lymphoma, iwCLL response criteria and IWWM response criteria.
Timepoint [7] 0 0
Up to 2.7 years

Eligibility
Key inclusion criteria
- Histologic documentation of disease: B-cell NHL or 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: 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 pregnancy
test (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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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, or has evidence of graft
versus host disease that requires immunosuppressant therapy

- Prior chemotherapy, targeted therapy, immunotherapy or 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), 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,
whichever is longer. For investigational agents with long half-lives a wash-out of 4
weeks is acceptable

- Active autoimmune disease that requires systemic immunosuppressive medications
(example, chronic corticosteroid, methotrexate, or tacrolimus)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
France
State/province [3] 0 0
Lille
Country [4] 0 0
France
State/province [4] 0 0
NANTES Cedex 1
Country [5] 0 0
France
State/province [5] 0 0
Pierre Benite
Country [6] 0 0
Israel
State/province [6] 0 0
Haifa
Country [7] 0 0
Israel
State/province [7] 0 0
Jerusalem
Country [8] 0 0
Israel
State/province [8] 0 0
Ramat Gan
Country [9] 0 0
Israel
State/province [9] 0 0
Tel Aviv
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid
Country [13] 0 0
Spain
State/province [13] 0 0
Pamplona
Country [14] 0 0
Spain
State/province [14] 0 0
Salamanca
Country [15] 0 0
Taiwan
State/province [15] 0 0
Kaohsiung County
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taichung
Country [17] 0 0
Taiwan
State/province [17] 0 0
Tainan
Country [18] 0 0
Taiwan
State/province [18] 0 0
Taipei
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Birmingham
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Leicester
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Manchester
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04540796
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04540796