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A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma

Study acronym: CARTITUDE-2
StatusActive, Not Recruiting
PhasePhase 2
Started2019-11-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Aug 4, 2026 → Feb 26, 2027
See other at-risk trials from Johnson & Johnson

Amendment history

The 50 most recent of 85 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-08-27
Study Status v84
Re-verified, no change to tracked fields
2026-07-02
Study Status v83
Primary completion pushed: 2026-08-04 → 2027-02-26
Completion moved earlier: 2029-09-03 → 2028-08-25
2026-06-03
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing v82
Primary endpoint(s) modified2 entries, revised
WasCohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD), Cohorts G and H: Percentage of Participants with Sustained MRD Negative Complete Response (CR)
NowCohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD), For US sites only: Cohort G: Percentage of Participants with Sustained MRD Negative Complete Response (CR)
Enrollment target210→208
Eligibility criteria+26 characters
[...] rapy with a carfilzomib-based triplet or quadruplet regimen For US sites only: Cohort G: Not considered for high-dose chemotherapy with aut [...] al of high-dose chemotherapy with ASCT as initial treatment Cohort H: Considered a candidate for high-dose chemotherapy with ASCT as initial treatment Cohorts A, B, C, E, and Cohort G, H(for US sites only): Serum monoclonal paraprotein (M-protein) level greater tha [...] sfy the measurable disease criteria Cohorts A, B, C, D, E, F, and Cohort G, H(for US sites only): Eastern Cooperative Oncology Group (ECOG) performance stat [...] clinical signs of meningeal involvement [...]
Secondary endpoints23 to 24 entries
CohortsFor US sites only: Cohort G and H: Percentage of Participants with Complete Response (CR) or Better CohortsFor US sites only: Cohort G and H: Percentage of Participants with MRD-negative CR or sCR CohortsFor US sites only: Cohort G and H: Progression-free Survival on Next-line Therapy (PFS2) CohortsFor US sites only: Cohort G and H: Overall Survival (OS) CohortsFor US sites only: Cohort G and H: Progression-free Survival (PFS) CohortsFor US sites only: Cohort G and H: Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Whole Blood For US sites only: Cohort G [...]
2026-04-09
Study Status v81
Re-verified, no change to tracked fields
2026-03-16
Study Status, Contacts/Locations v80
Study sitesdetails revised at 1 of 47 sites
Show 45 earlier versions
2026-01-15
Study Status v79
Re-verified, no change to tracked fields
2025-12-18
Study Status v78
Completion date2028-01-17→2029-09-03
2025-12-04
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v77
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 237→confirmed 210
Study sitesdetails revised at 47 of 47 sites
2025-11-06
Study Status v76
Re-verified, no change to tracked fields
2025-10-09
Study Status, Contacts/Locations v75
Study sitesdetails revised at 1 of 47 sites
2025-09-11
Study Status v74
Re-verified, no change to tracked fields
2025-08-14
Study Status v73
Primary completion date2025-12-01→2026-08-04
Completion date2028-11-13→2028-01-17
2025-07-18
Study Status, Contacts/Locations v72
Study sitesdetails revised at 4 of 47 sites
2025-07-17
4 amendments v68-v71
4 re-verifications since 2025-04-02, no change to tracked fields
2025-03-28
Study Status, Contacts/Locations v67
Study sitesdetails revised at 1 of 47 sites
2025-02-03
2 amendments v65-v66
2 re-verifications since 2025-01-30, no change to tracked fields
2025-01-09
Study Status, Contacts/Locations v64
Study sites46→47
2025-01-08
Study Status v63
Re-verified, no change to tracked fields
2024-12-05
Study Status, Contacts/Locations v62
Study sites44→46
2024-12-04
Study Status v61
Re-verified, no change to tracked fields
2024-10-23
Study Status, Contacts/Locations v60
Study sites42→44
2024-10-08
Study Status, Contacts/Locations v59
Study sites41→42
2024-09-20
Study Status, Contacts/Locations, References v58
Study sites39→41
2024-08-13
Study Status, Contacts/Locations v57
Study sitesdetails revised at 10 of 39 sites
2024-07-16
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v56
Trial statusActive, Not Recruiting→Recruiting
Enrollment target169→237
Study sites37→39
2024-06-18
Study Status, Contacts/Locations v55
Primary completion date2025-05-30→2025-12-01
Study sites37 entries, revised
Washington University School ofOf Medicine Hosp. Clinico Univ. de Salamanca
2024-05-22
Study Status, Contacts/Locations v54
Study sites33→37
2024-04-23
Study Status v53
Re-verified, no change to tracked fields
2024-03-26
Study Status, Contacts/Locations v52
Study sites33 entries, revised
Dana- Farber Cancer Institute Hopital Saint- Louis
2024-02-27
2 amendments v50-v51
2 re-verifications since 2024-01-30, no change to tracked fields
2024-01-02
Study Status, Contacts/Locations v49
Study sites33 entries, revised
UniversitätsklinikumUniversitatsklinikum WürzburgWurzburg
2023-12-05
Study Status, Contacts/Locations v48
Completion date2027-06-10→2028-11-13
Study sites33 entries, revised
University of California, San Francisco
2023-11-17
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v47
Completion date2025-05-30→2027-06-10
Eligibility criteria+1,836 characters
[...] ria, Beta 2 microglobulin greater than or equal to (>=) 5.5 milligrammilligrams per liter (mg/L) (via local or central laboratory assessmen [...] rapy with a carfilzomib-based triplet or quadruplet regimen Cohort G: Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: a) Ineligibility due to advanced age; or b) Ineligibility due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or c) [...] Cohorts A, B, C, E, G, H: Serum monoclonal paraprotein (M-protein) level greater tha [...] .0 gram per decil [...]
Secondary endpoints17 to 23 entries
Cohorts A, B, C, D, E, and F: VGPR or Better Rate Cohorts A, B, C, D, E, and F: Clinical Benefit Rate (CBR) Cohorts A, B, C, D, E, and F: MRD Negative Rate at 12 Months for Participants who Achieve a Complete Response (CR) Cohorts A, B, C, D, E, and F: MRD Negative Rate Across Clinical Response Number of Participants with Vital SignSigns Abnormalities Cohorts A, B, C, D, E, and F: Levels of B-Cell Maturation Antigen (BCMA) Expressing Cells and Soluble BCMA Cohorts A, B, C, D, E, and F: Systemic Inflammatory Cytokine Concentrations Cohorts A, B, C, D, E, and F: Levels of JNJ-68284528 T Cell Exp [...] [...]
Primary endpoints1 to 2 entries
Cohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD) Cohorts G and H: Percentage of Participants with Sustained MRD Negative Complete Response (CR)
Study description-1,732 characters
Multiple myeloma is characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. The main aim of the study is to determine the safety and efficacy of JNJ-68284528 in various clinical settings. JNJ-68284528 is an autologou [...]
Study sitesdetails revised at 1 of 33 sites
2023-09-12
3 amendments v44-v46
3 re-verifications since 2023-07-19, no change to tracked fields
2023-06-28
Study Status, Contacts/Locations v43
Study sitesdetails revised at 1 of 33 sites
2023-05-30
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v42
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 157→confirmed 169
Study sitesdetails revised at 33 of 33 sites
2023-05-02
Study Status v41
Re-verified, no change to tracked fields
2023-04-11
Study Status, Contacts/Locations v40
Primary completion date2024-08-01→2025-05-30
Study sitesdetails revised at 28 of 33 sites
2023-03-23
Study Status, Contacts/Locations v39
Study sites43→33
2023-02-23
Study Status v38
Completion date2026-02-25→2025-05-30
2023-01-27
Study Status, Contacts/Locations v37
Study sites43 entries, revised
CHRU de Lille - HôpitalHopital Claude Huriez Clinica Univ. deDe Navarra
2022-12-28
Study Status, Contacts/Locations v36
Study sitesdetails revised at 1 of 43 sites
2022-12-01
Study Status v35
Re-verified, no change to tracked fields
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
Trial Details
NCT Number NCT04133636
Lead Sponsor Janssen Research & Development, LLC
Conditions Multiple Myeloma
Enrollment 208 participants
Start Date 2019-11-07
Primary Completion 2027-02-26 (estimated)
Study Completion 2028-08-25 (estimated)
Updated on ClinicalTrials.gov 2026-09-25