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PD-1 Inhibitor

TAA-T Cells + Nivolumab for Lymphoma

Phase 1

Waitlist Available

Led By Boyu Hu, MD

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Steroids less than 0.5 mg/kg/day prednisone or equivalent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will enroll patients who have already tried other treatments and failed (group A) or who are at high risk of their lymphoma coming back after an autologous hematopoeitic stem cell transplant (group B).

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include immune system reactions like inflammation in various organs, infusion-related reactions, changes in thyroid function which may require hormone replacement therapy, digestive enzyme abnormalities, and general symptoms such as fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have Hodgkin's lymphoma.

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I am taking less than 0.5 mg/kg/day of steroids.

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I have been treated with Nivolumab for at least 8 weeks.

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I need more than one treatment before my stem cell transplant for Hodgkin lymphoma.

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My condition relapsed within a year of diagnosis or within 6 months after finishing initial treatment.

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I have had a solid organ transplant.

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I have relapsed or unresponsive Hodgkin Lymphoma or Diffuse Large B-cell Lymphoma.

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I need more than one treatment before my stem cell transplant.

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I haven't achieved complete remission before my stem cell transplant.

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I am older than 12 years.

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I can do most activities but may need help.

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I've had 2 treatments fail, including stem cell and CAR T-cell therapies.

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I have DLBCL and am at high risk of relapse after a stem cell transplant.

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My Hodgkin lymphoma did not improve after at least one treatment, including Brentuximab Vedotin.

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My condition worsened or didn't improve after a stem cell transplant using my own cells.

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I can do most activities but may need help.

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I have had a bone marrow transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Product-Emergent Adverse Events

Secondary outcome measures

Tumor response to combination immunotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nivolumab with TAA-T cellExperimental Treatment2 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Catherine BollardLead Sponsor

13 Previous Clinical Trials

313 Total Patients Enrolled

Boyu Hu, MDPrincipal InvestigatorUTAH

1 Previous Clinical Trials

39 Total Patients Enrolled

Media Library

Nivolumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03843294 — Phase 1

Hodgkin's Lymphoma Research Study Groups: Nivolumab with TAA-T cell

Hodgkin's Lymphoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03843294 — Phase 1

Nivolumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03843294 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join this medical research project?

"Eligible potential participants of this medical study must have diffuse large b-cell lymphoma, be between 12 and 80 years old, and there are 18 positions available."

Answered by AI

What medical applications do TAA-T cells usually serve?

"TAA-T cells are widely used in oncology to treat malignant neoplasms, such as unresectable melanoma, metastatic esophageal adenocarcinoma and squamous cell carcinoma."

Answered by AI

Are there any available openings in this experiment at present?

"Indeed, clinicaltrials.gov reveals that this trial is still actively seeking participants since its initial posting on June 24th 2019 and recent update of August 30th 2022. Only 18 individuals need to be recruited from one medical centre."

Answered by AI

Has the FDA given its greenlight to TAA-T cells for medical uses?

"Due to the experimental stage of this treatment, TAA-T cells were judged a 1 on our safety scale. This is because Phase 1 trials have limited supporting data for both its efficacy and security."

Answered by AI

Has there ever been a similar assessment done prior to this?

"Globally, 717 active studies involving TAA-T cells can be found across 49 nations and 2356 cities. Ono Pharmaceutical Co. Ltd were the first to initiate a clinical trial for this therapy back in 2012; their Phase 1 & 2 trials involved 659 participants yet since then 252 more experiments have been launched."

Answered by AI

Does the age restriction for this clinical experiment only involve those over 55?

"For this medical trial, enrolment is open to individuals over the age of 12 and below 80 years old."

Answered by AI

Are there any antecedent investigations involving TAA-T cells?

"Currently, there are 717 active clinical trials for TAA-T cells with 82 in Phase 3. Of the 40281 locations running these studies, many are based out of Basel, BE."

Answered by AI

How many participants are currently enrolled in this research study?

"Indeed, the details posted on clinicaltrials.gov reveal that this trial is currently open to recruitment. The study was first made available on June 24th 2019 and then edited as recently as August 30th 2022. There are 18 openings at 1 medical centre."

Answered by AI

Recent research and studies

Blood AdvancesJournal

Tumor-associated Antigen–specific T Cells with Nivolumab Are Safe and Persist in Vivo in Relapsed/refractory Hodgkin Lymphoma

Dave, Hema, Madeline Terpilowski, Mimi Mai, Keri Toner, Melanie Grant, Maja Stanojevic, Christopher Lazarski, et al.. 2022. “Tumor-associated Antigen–specific T Cells with Nivolumab Are Safe and Persist in Vivo in Relapsed/refractory Hodgkin Lymphoma”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2021005343.

Blood AdvancesJournal

Tumor-associated Antigen–specific T Cells with Nivolumab Are Safe and Persist in Vivo in Relapsed/refractory Hodgkin Lymphoma

clinicaltrials.govStudy

Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma

Catherine Bollard 2019. "Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03843294.