Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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).

Official Title

A Phase 1b-2, Open-Label Study of JNJ-68284528, A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

Details

This study will evaluate the safety and efficacy of JNJ-68284528. The study will include two phases. In Phase1b the study will enroll adults with multiple myeloma with interval assessments for potential dose escalation or de-escalation in subsequent participants. The dose selected at the completion of phase 1b will be used in Phase 2. Following consent, enrolled participants will undergo an apheresis procedure to collect cells for manufacture of investigational drug product (JNJ-68284528). Following manufacture of the drug product, participants will undergo lymphodepletion prior to infusion of JNJ-68284528. Participants will be followed for at least 2 years after study drug infusion, with long-term 15 year follow-up on a separate study. The study will evaluate safety, biomarkers, pharmacokinetic/pharmacodynamic evaluations and efficacy.

Keywords

Multiple Myeloma Neoplasms, Plasma Cell JNJ-68284528

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 regimens 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 regimen a) Undergone at least 1 complete cycle of treatment for each regimen, 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
  • Have documented disease progression within 12 months of starting the most recent anti-myeloma therapy
  • Have Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1

You CAN'T join if...

  • 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) 6 months prior to enrollment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiac function (left ventricular ejection fraction [LVEF] less than [<]45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed 8 weeks of apheresis)
  • Have systemic corticosteroid therapy of greater than 5 mg/day of prednisone (or equivalent dose of another corticosteroid) within 2 weeks 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 12 weeks before apheresis
  • Have known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • City of Hope not yet accepting patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT03548207
Phase
Phase 1/2
Study Type
Interventional
Last Updated