TAA-T Cells + Nivolumab for Lymphoma

Overseen By Fahmida Hoq, MBBS, MS

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Catherine Bollard

Must be taking: Nivolumab

Must not be taking: ATG, Campath

Disqualifiers: Uncontrolled infections, Active HIV, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase I, open-label multi-site trial designed to evaluate the safety of administering rapidly-generated Tumor associated antigen specific T cells (TAA-T) with the Programmed Death1 (PD-1) inhibitor Nivolumab, in relapsed/refractory lymphoma (rel/ref) patients with measurable disease (group A) or as adjunctive therapy following autologous hematopoeitic stem cell transplant(HSCT) for patients at high risk of relapse (group B). The purpose of this study is to find out if the tumor specific T cells given with Nivolumab are safe and to learn what the side effects are and if the combination can help patients with relapsed lymphomas.

Research Team

Boyu Hu, MD

Principal Investigator

UTAH

Eligibility Criteria

This trial is for people over 12 with certain types of lymphoma that have come back or didn't respond to treatment. They should not be pregnant, have HIV, or had a solid organ transplant. Participants need a minimum level of physical ability and blood cell counts, haven't used some therapies recently, and agree to use birth control.

Inclusion Criteria

I have mild side effects from Nivolumab, manageable with treatment.

Failure to meet institutional guidelines for treatment with Nivolumab

You have Hodgkin's lymphoma.

Exclusion Criteria

I do not have any infections that are not responding to treatment.

I have mild or noticeable side effects from previous treatments.

You have received any experimental treatments within 28 days before being screened for this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Safety Monitoring

Initial safety monitoring or DLT group with 6 patients enrolled to evaluate safety of TAA-T cells and Nivolumab

6 weeks

Multiple visits for safety assessments

Treatment

Patients receive Nivolumab at least 8 weeks prior to first TAA-T cell infusion, followed by two TAA-T cell infusions given 2 weeks apart

12 weeks

Regular visits every 2 weeks for infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tumor response assessment

1 year

Periodic imaging and assessments

Treatment Details

Interventions

• Nivolumab
• TAA-T cells

Trial Overview The study tests TAA-T cells combined with the PD-1 inhibitor Nivolumab in two groups: those with measurable disease after relapse (Group A) and as additional therapy post-stem cell transplant for high-risk patients (Group B). It aims to assess safety and potential benefits against lymphoma.

Participant Groups

Group I: Nivolumab with TAA-T cell Experimental Treatment 2 Interventions

Patients will receive doses of Nivolumab at a minimum of 8 weeks prior to first TAA-T cell infusion and additional dose(s) of Nivolumab will be given after 4 weeks following second TAA-T cell infusion starting at week 7 from first infusion of TAA-T.If patient meets eligibility criteria for TAA-T cell infusion, the patient will receive two TAA-T cell infusions given 2 weeks apart

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

Approved in United States as Opdivo for:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Catherine Bollard

Lead Sponsor

Trials

13

Recruited

290+