Cell Therapy for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byElizabeth L Budde, MD,PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an effective treatment for NHL.

Eligibility Criteria

This trial is for adults with high-risk B-cell non-Hodgkin lymphoma who've had a relapse or didn't respond to initial treatment. They must be fit enough for stem cell transplant (Karnofsky score ≥70%), not pregnant, and have a life expectancy over 16 weeks. Excluded are those with HIV, prior transplants, active autoimmune diseases needing steroids, hepatitis B/C infection, or on other trials.

Inclusion Criteria

My cancer returned after initial treatment or didn't respond to the first treatment.

I am able to care for myself but may not be able to do active work.

I am eligible for a stem cell transplant using my own cells.

+3 more

Exclusion Criteria

I rely on corticosteroids for my health condition.

I have an active hepatitis B or C infection.

I don't have any health issues that would prevent me from undergoing a stem cell transplant.

+6 more

Participant Groups

The study tests genetically engineered lymphocyte therapy after stem cell transplant in patients with aggressive lymphoma. It includes rituximab and chemotherapy before the transplant and factors like filgrastim to help move stem cells from bone marrow into the blood for collection.

1Treatment groups

Experimental Treatment

Group I: Treatment (cellular adoptive immunotherapy following PBSCT)Experimental Treatment7 Interventions

Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with G-CSF and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplant. Patients receive standard myeloablative conditioning followed by autologous PBSCT. Patients then undergo infusion of ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR on day 2 or 3 after transplant.

Rituximab is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Rituxan for: