FT522 combined with rituximab for treating relapsed B-cell lymphoma
A Phase 1 Study of FT522 in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Lymphoma
This study is testing if a new treatment called FT522, given with the drug rituximab, can safely help people with relapsed B-cell lymphoma feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fate Therapeutics Industry-sponsored |
| Drugs / interventions | rituximab, chimeric antigen receptor, chemotherapy, radiation, prednisone |
| Locations | 6 sites (Detroit, Michigan and 5 other locations) |
| Trial ID | NCT05950334 on ClinicalTrials.gov |
What this trial studies
This phase 1 study evaluates the safety and tolerability of FT522 when administered alongside rituximab in patients with relapsed or refractory B-cell lymphoma. The study aims to determine the recommended phase 2 dose of FT522, with assessments conducted both with and without conditioning chemotherapy. Participants will be closely monitored for adverse effects and treatment responses throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with specific types of B-cell lymphoma who have experienced relapse after prior treatments and have no available curative options.
Not a fit: Patients with B-cell lymphoma who have not received prior anti-CD20 monoclonal antibody treatment or those with curable disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment choices for relapsed or refractory B-cell lymphoma.
How similar studies have performed: While this approach is novel in its specific combination, similar studies involving immunotherapies and monoclonal antibodies have shown promising results in treating B-cell lymphomas.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of B-cell lymphoma (BCL) as: (1) histologically documented lymphomas expected to express CD19 and CD20, including Grades 1 to 3B follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), mantle cell lymphoma (MCL), transformed indolent non-Hodgkin lymphoma (tNHL), diffuse large B-cell lymphoma (DLBCL) \[not otherwise specified\], high-grade BCL, primary mediastinal BCL, and Richter transformation (RT; expansion part of study only); (2) R/R disease following at least 1 prior systemic regimen containing an anti-CD20 monoclonal antibody (mAb) for which the participant has no available curative treatment options; and (3) evaluable F-fluorodeoxyglucose (FDG)-avid disease, or measurable disease defined by at least one bi dimensionally measurable lesion * Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception Exclusion Criteria: * Females who are pregnant or breastfeeding * Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2 * Body weight \<50 kg * Evidence of insufficient organ function * Receipt of any biological therapy, chemotherapy (except for rituximab), or any investigational therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or localized radiation therapy to a target lesion within 14 days prior to Day 1 * Currently receiving or likely to require systemic immunosuppressive therapy, e.g., prednisone \>5 mg daily, for any reason from Day -5 to Day 29, with the exception of corticosteroids as a pre medication required for conditioning chemotherapy or rituximab * Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic chimeric antigen receptor (CAR) T-cell therapy within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host disease (GvHD) therapy * Receipt of an allograft organ transplant * Non-malignant central nervous system (CNS) disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment * Clinically significant cardiovascular disease * Clinically significant infections * Receipt of a live vaccine \<6 weeks prior to start of study intervention * Known allergy to human albumin or DMSO * Any medical condition or clinical laboratory abnormality that per investigator or medical monitor judgement, precludes safe participation in and completion of the study, or that could affect compliance with protocol conduct or interpretation of results
Where this trial is running
Detroit, Michigan and 5 other locations
- Karmanos Cancer Center — Detroit, Michigan, United States (Recruiting)
- University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Tennessee Oncology — Nashville, Tennessee, United States (Recruiting)
- Baylor Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Fate Trial Disclosure
- Email: FateTrialDisclosure@fatetherapeutics.com
- Phone: 866-875-1800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.