Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

— TRANSCENDWORLD  

Official title:

A Phase 2, Single-arm, Multi-center Trial to Determine the Efficacy and Safety of JCAR017 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or With Other Aggressive B-Cell Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484702
• Other study ID #: JCAR017-BCM-001
• Secondary ID: U1111-1209-40552
• Status: Completed
• Phase: Phase 2
• Start date: September 7, 2018
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)

Description:

This is a study to determine the efficacy and safety of JCAR017 in adult participants with aggressive B-cell NHL. The study will enroll participants in Europe and Japan with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS; de novo or transformed follicular lymphoma [tFL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (HGBL), follicular lymphoma Grade 3B (FL3B), and primary central nervous system lymphoma (PCNSL). Participants with secondary central nervous system (CNS) involvement are allowed.

Once enrolled, participants will undergo leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants will receive lymphodepleting chemotherapy followed by infusion of JCAR017. JCAR017 will be administered by intravenous infusion. Participants will be followed for approximately 2 years after their JCAR017 infusion for safety, disease status, survival and health-related quality of life.

Delayed adverse events following exposure to gene modified T cells will be assessed and long-term persistence of these modified T cells will continue to be monitored under a separate long-term follow-up protocol for up to 15 years after JCAR017 infusion as per competent authority guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological confirmation of diagnosis at last relapse

• Adequate organ function

• Adequate vascular access for leukapheresis procedure

Exclusion Criteria:

• Prior history of malignancies, other than aggressive relapsed/refractory Non-Hodgkin Lymphoma, unless the participant has been in remission for = 2 years with the exception of non-invasive malignancies

• Received previous CD19-targeted therapy

• Progressive vascular tumor invasion, thrombosis, or embolism

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Aggression
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• JCAR017
Specified dose on specified days

Locations

Country	Name	City	State
Austria	Local Institution - 101	Wien
Belgium	Local Institution - 351	Gent
Finland	Local Institution - 551	Helsinki
France	Local Institution - 202	Lille
France	Local Institution - 203	Paris Cedex 10
France	Local Institution - 201	Pierre Benite cedex
Germany	Local Institution - 152	Dresden
Germany	Local Institution - 155	Heidelberg
Germany	Local Institution - 151	Köln
Germany	Local Institution - 154	München
Germany	Local Institution - 153	Ulm
Italy	Local Institution - 402	Milan
Italy	Local Institution - 401	Torino
Japan	Local Institution - 601	Chuo-ku	Tokyo
Japan	Local Institution - 602	Minato-ku	Tokyo
Netherlands	Local Institution - 301	Rotterdam
Spain	Local Institution - 451	Barcelona
Switzerland	Local Institution - 251	Bern
United Kingdom	Local Institution - 501	London
United Kingdom	Local Institution - 502	Manchester	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

Austria,  Belgium,  Finland,  France,  Germany,  Italy,  Japan,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) of JCAR017 in participants with Non-Hodgkin Lymphoma (NHL; including secondary central nervous system (CNS) involvement)		Up to 2 years after JCAR017 infusion
Primary	ORR of JCAR017 in participants with relapsed/refractory (r/r) primary central nervous system lymphoma (PCNSL)		Up to 2 years after JCAR017 infusion
Primary	Adverse Events (AEs) in participants intended to be treated as outpatients		Up to 2 years after JCAR017 infusion
Secondary	Incidence of Adverse Events		Up to 2 years after JCAR017 infusion
Secondary	Incidence of Serious Adverse Events		Up to 2 years after JCAR017 infusion
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 2 years after JCAR017 infusion
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 2 years after JCAR017 infusion
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 2 years after JCAR017 infusion
Secondary	Adverse Events (AEs) in participants treated as outpatients		Up to 2 years after JCAR017 infusion
Secondary	Overall Response Rate (ORR) in participants intended to be treated as outpatients		Up to 2 years after JCAR017 infusion
Secondary	Complete Response Rate (CRR)		Up to 2 years after JCAR017 infusion
Secondary	Event-free survival (EFS)		Up to 2 years after JCAR017 infusion
Secondary	Progression-free survival (PFS)		Up to 2 years after JCAR017 infusion
Secondary	Overall survival (OS)		Up to last participant last visit (approximately 40 months)
Secondary	Duration of response (DOR)		Up to 2 years after JCAR017 infusion
Secondary	Pharmacokinetics by quantitative polymerase chain reaction (qPCR) - Maximum plasma concentration of drug (Cmax)		Up to 2 years after JCAR017 infusion
Secondary	Pharmacokinetics by qPCR - Time to peak concentration (Tmax)		Up to 2 years after JCAR017 infusion
Secondary	Pharmacokinetics by qPCR - Area under the curve (AUC)		Up to 2 years after JCAR017 infusion
Secondary	Patient-Reported Outcomes - European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire		Up to 2 years after JCAR017 infusion
Secondary	Patient-Reported Outcomes - Functional Assessment of Cancer Therapy-Lymphoma "Additional concerns" subscale		Up to 2 years after JCAR017 infusion

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting