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
I'm interested