Advancing Regenerative Medicine

Stanford's Alpha Clinic supports the advancement of regenerative therapies in the following ways

Current Cell and Gene Therapy Clinical Trial List:

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 not 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

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kristin Ana-Marie Muller
+1 650-725-1647
Not Recruiting

The Alpha Clinic Network

We are part of a state-wide network funded by the California Institute for Regenerative Medicine

This network includes: