Phase 2
Completed N=126
A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT03548207 ↗Enrolled (actual)
126
Serious AEs
50.9%
Results posted
Apr 2024
Primary outcomePrimary: Phase 1b: Number of Participants With Adverse Events as Per Severity — 0; 0; 2; 26 Participants
Summary
The purpose of the study is to characterize safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of JNJ-68284528 (Phase 2).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: Number of Participants With Adverse Events as Per Severity |
0; 0; 2; 26; 1 | — |
| PRIMARY Phase 2: Overall Response Rate (ORR) |
97.1; 100.0 | — |
| SECONDARY Phase 2: Number of Participants With Adverse Events (AEs) as Per Severity |
0; 0; 0; 1; 5; 0 | — |
| SECONDARY Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-68284528 Transgene |
38965; 52841; 44077 | — |
| SECONDARY Phase 1b and Phase 2: Actual Sampling Time of Last Measurable Analyte Concentration (Tlast) of JNJ-68284528 Transgene |
127.13; 122.98; 129.89 | — |
| SECONDARY Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of JNJ-68284528 Transgene |
588162; 1356191; 4062950 | — |
| SECONDARY Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of JNJ-68284528 Transgene |
542728; 1321427; 7173538 | — |
| SECONDARY Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 |
483; 1472; 1614 | — |
| SECONDARY Phase 1b and Phase 2: T Cell Persistence After a Single Infusion of JNJ-68284528 |
84.08; 100.23; 56.81 | — |
| SECONDARY Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 To Last Measurable Concentration (AUC0-last) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 |
7758; 40073; 152904 | — |
| SECONDARY Phase 1b and Phase 2: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinite Time (AUC0-infinity) of CD3+CAR+ Cells in Blood After a Single Infusion of JNJ-68284528 |
10937; 31966; 7144.5 | — |
| SECONDARY Phase 1b and Phase 2: Mean Concentration of Soluble B-cell Maturation Antigen (BCMA) Levels in Serum After Single Infusion of JNJ-68284528 |
2.25; 2.01; 5.61; 6.70; 7.05 | — |
| SECONDARY Number of Participants With Depletion of BCMA Expressing Cells |
0; 0 | — |
| SECONDARY Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations |
3.66; 3.81; 1.62; 3.59; 4.05; 1.76 | — |
| SECONDARY Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of CAR-T Cells (CD3+CAR+ Cells in Blood) After a Single Infusion of JNJ-68284528 |
483; 1472; 1614 | — |
| SECONDARY Phase 1b and Phase 2: Maximum T Cell Expansion After a Single Infusion of JNJ-68284528 |
483; 1472; 1614 | — |
| SECONDARY Phase 1b and Phase 2: Percentage of Participants With Positive Antibodies to JNJ-68284528 |
48.3; 35.3; 44.4 | — |
| SECONDARY Phase 1b and Phase 2: Very Good Partial Response (VGPR) or Better Response Rate |
96.6; 94.1; 100.0 | — |
| SECONDARY Phase 1b and Phase 2: Minimal Residual Disease (MRD) Negative Rate |
100.0; 89.7; 75.0 | — |
| SECONDARY Phase 1b and Phase 2: Clinical Benefit Rate (CBR) |
100.0; 97.1; 100.0 | — |
| SECONDARY Phase 1b and Phase 2: Duration of Response (DOR) |
NA; NA; NA | — |
| SECONDARY Phase 1b and Phase 2: Time to First Response |
0.95; 0.95; 0.92 | — |
| SECONDARY Phase 1b and Phase 2: Progression-free Survival (PFS) |
NA; NA; NA | — |
| SECONDARY Phase 1b and Phase 2: Overall Survival |
NA; NA; 27.04 | — |
| SECONDARY Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 |
-0.1; 0; 0; 0; 0; 0 | — |
| SECONDARY Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Utility Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 |
-0.05; -0.06; -0.03; 0.01; -0.04; 0.00 | — |
| SECONDARY Phase 2 (US Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 |
-6.7; 0.6; 2.2; 5.3; 1.9; 6.4 | — |
| SECONDARY Phase 2 (Japan Population): Change From Baseline in EuroQol Five Dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 |
-13.75; -0.75; -4.50; -3.00; -1.88; 0.00 | — |
| SECONDARY Phase 2 (US Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 |
-14.4; -7.2; -5.2; -2.3; -4.8; 0 | — |
| SECONDARY Phase 2 (Japan Population): Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Subscales at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 |
-2.50; -4.17; -1.67; 0.00; -1.67; -0.83 | — |
| SECONDARY Phase 2: Change From Baseline in Patient Global Impression of Severity (PGIS) Score at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352, 380 |
-0.3; 0.3; -0.3; -0.1; -0.3; 0.3 | — |
| SECONDARY Phase 2: Patient Global Impression of Change (PGIC) Score at Days 28, 56, 78, 100 |
2.7; 2.8; 2.5; 2.9; 2.2; 2.5 | — |
| SECONDARY Phase 2 (US Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296, 324, 352 and 380 |
5.7; -5.5; 1.6; -2.7; -3.3; -3.9 | — |
| SECONDARY Phase 2 (Japan Population): Change From Baseline in EORTC QLQ-MY20 at Days 7, 28, 56, 78, 100, 128, 156, 184, 212, 240, 268, 296 and 324 |
12.50; 8.33; 0.00; 0.00; 0.00; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Have documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Have measurable disease at Screening as defined by any of the following a) Serum monoclonal paraprotein (M-protein) level more than or equal to (>=) 1.0 gram per deciliter(g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24hr); or b) Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Have received at least 3 prior multiple myeloma treatment lines of therapy or are double refractory to an immunomodulatory drug (IMiD) and proteasome inhibitor (PI) (refractory multiple myeloma as defined by IMWG consensus criteria). Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single lines of therapy a) Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the regimen
- Have received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody
- Participant must have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or within 12 months of their last line of therapy. Confirmation may be from either central or local testing. Also, participants with documented evidence of progressive disease (as above) within the previous 6 months and who are refractory or non-responsive to their most recent line of therapy afterwards are eligible
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
Exclusion Criteria
- Have received prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
- Have received any therapy that is targeted to B-cell maturation antigen (BCMA)
- Have following cardiac conditions: a) New York Heart Association (NYHA) stage III or IV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) less than or equal to ( = 70 mg of prednisone within the 7 days prior to apheresis
- Have received either of the following: a) An allogenic stem cell transplant within 6 months before apheresis. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD) b) An autologous stem cell transplant less than or equal to (<=) 12 weeks before apheresis
- Have known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
Data sourced from ClinicalTrials.gov (NCT03548207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.