Advancing Regenerative Medicine

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

Maintain a Minimum Number of Clinical trials

Current Cell and Gene Therapy Clinical Trial List:

A Phase 2 Study of Firi-cel in Patients with Relapsed/refractory Large B-cell Lymphoma

This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Fludarabine (Conditional therapy)
  • drug: Cyclophosphamide Monohydrate (Conditional therapy)
  • drug: firi-cel (Experimental drug)

Eligibility

Key Inclusion Criteria:

* Aged ≥18 years
* Relapsed or refractory, histologically confirmed large B-cell lymphoma.
* Must have relapsed or refractory diseae after last therapy.
* For enrollment in cohort 1, patients must have previously received a CD19-directed CAR T-cell therapy
* For enrollment in cohort 3, patients must have received at least two prior lines of therapy including a bispecific T-cel engaging antibody therapy.
* Must have at least one radiographically measurable lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematological, renal, and liver function
* Willing and able to remain within 1 hour of the treating center for at least 4 weeks after infusion.

Key Exclusion Criteria:

* Clinically significant concurrent medical illness
* Active fungal, bacterial, viral or other infection.
* Prior allogeneic stem cell transplant or allogeneic cell therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Kelly Chyan
650-625-8130
Not Recruiting

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Link to All Stanford Clinical Trials

Stanford Affiliates

The Alpha Clinic Network

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

This network includes: