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

NCT03484702 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: JCAR017-BCM-001U1111-1209-40552017-000106-38
• Study Type: interventional
• Target: 113
• Locations: 11 countries
• Sites: 20

Brief 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)

Conditions

Lymphoma, Non-Hodgkin

Keywords

Non-Hodgkin lymphoma; Aggressive B-cell non-Hodgkin lymphoma; Diffuse large B-cell lymphoma; Relapse / refractory lymphoma; Transplant not eligible; High-grade B-cell lymphoma; Primary central nervous system lymphoma; Transformed follicular lymphoma; Follicular lymphoma Grade 3B; JCAR017; Liso-Cel

Outcome Measures

Primary Outcomes (7)

• Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3

  Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: No * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: No * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: No * Organ enlargement: Spleen length decreased \> 50% * New lesions: No

  From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)

• Overall Response Rate (ORR) Per Investigator in Cohort 4

  Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: None/normal * Organ enlargement: Spleen length decreased \> 50% * New lesions: No

  From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)

• Overall Response Rate (ORR) Per Investigator in Cohort 5

  Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR). Complete response (CR): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative Partial response (PR): * Brain imaging: 50% decrease in enhancing tumor, no contrast enhancement. * Corticosteroid dose: Irrelevant * Eye examination: Minor RPE abnormality, decrease in vitreous cells or retinal infiltrate. * Cerebrospinal fluid cytology: Negative, persistent or suspicious

  From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)

• Number of Participants With Adverse Events in Cohort 7

  An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

  From leukapheresis to end of study (up to approximately 63 months)

• Number of Participants With Serious Adverse Events (SAEs) in Cohort 7

  A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

  From leukapheresis to end of study (up to approximately 63 months)

• Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7

  JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).

  At Baseline and Day 29 after JCAR017 infusion

• Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7

  JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).

  At Baseline and Day 29 after JCAR017 infusion

Secondary Outcomes (16)

• Number of Participants With Adverse Events in Cohorts 1, 2, 3, 4, and 5

  From leukapheresis to end of study (up to approximately 63 months)

• Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5

  From leukapheresis to end of study (up to approximately 63 months)

• Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5

  At Baseline and Day 29 after JCAR017 infusion

• Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5

  At Baseline and Day 29 after JCAR017 infusion

• Overall Response Rate (ORR) in Cohort 7

  From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)

Study Arms (1)

Administration of JCAR017

EXPERIMENTAL

Drug: JCAR017

Interventions

JCAR017 DRUG

Specified dose on specified days

Also known as: Lisocabtagene Maraleucel (liso-cel)

Administration of JCAR017

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of diagnosis at last relapse
• Adequate organ function
• Adequate vascular access for leukapheresis procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (20)

Local Institution - 101

Vienna, 1090, Austria

Location

Local Institution - 351

Ghent, 9000, Belgium

Location

Local Institution - 551

Helsinki, 00029, Finland

Location

Local Institution - 202

Lille, 59037, France

Location

Local Institution - 203

Paris, 75475, France

Location

Local Institution - 201

Pierre-Bénite, 69495, France

Location

Local Institution - 151

Cologne, 50937, Germany

Location

Local Institution - 152

Dresden, 01307, Germany

Location

Local Institution - 155

Heidelberg, 69120, Germany

Location

Local Institution - 154

München, 81377, Germany

Location

Local Institution - 153

Ulm, 89081, Germany

Location

Local Institution - 402

Milan, 20133, Italy

Location

Local Institution - 401

Torino, 10126, Italy

Location

Local Institution - 601

Chuo-ku, Tokyo, 104-0045, Japan

Location

Local Institution - 602

Minato-ku, Tokyo, 105-8470, Japan

Location

Local Institution - 301

Rotterdam, 3015 CE, Netherlands

Location

Local Institution - 451

Barcelona, 08035, Spain

Location

Local Institution - 251

Bern, 3010, Switzerland

Location

Local Institution - 502

Manchester, Lancashire, M20 4BX, United Kingdom

Location

Local Institution - 501

London, WC1E 6BT, United Kingdom

Location

Related Publications (1)

• Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

  PMID: 34515338 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Recurrence; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: June 5, 2018
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Locations

CH (1); ES (1); IT (2); AU (1); DE (5); NL (1); BE (1); FR (3); FI (1); JP (2); GB (2)