Gene Therapy Clinical Trials

A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Cilta-cel
  • drug: Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)

Eligibility


Inclusion Criteria:

   - Eligible for treatment with cilta-cel per United States prescribing information (USPI)
   or locally approved label

   - Participant is suffering from serious or life threatening multiple myeloma per USPI
   (or locally approved label, respectively), and re-apheresis, re-manufacturing, or
   other anti-myeloma directed therapies is not considered feasible or adequate per
   investigator

   - Has adequate general health status and organ function per investigator assessment and
   meets the criteria to receive cilta-cel out-of-specifications (OOS)

   - Meets the criteria to receive lymphodepleting chemotherapy

   - A woman of childbearing potential must have a negative highly sensitive serum
   (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test during screening and
   prior to the first dose of cyclophosphamide and fludarabine

Exclusion Criteria:

   - History of active uncontrolled infection or condition where an administration of
   cilta-cel OOS constitutes serious health risk to the participant

   - Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS
   including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI

   - Hepatitis B infection

   - Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or
   detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C

   - Seropositive for human immunodeficiency virus (HIV)

   - Uncontrolled autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kristin Ana-Marie Muller
+1 650-725-1647
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