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CAR T-cell Therapy

Combination Immunotherapy for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Lazaros Lekakis, MD

Research Sponsored by Lazaros Lekakis

Eligibility Criteria Checklist

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

Must have

At least one measurable lymphoma lesion

Primary mediastinal B cell lymphoma (PMBCL)

Must not have

Cardiac disease with NYHA II-IV functional group not allowed

Uncontrolled systemic hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test if a combination of CAR T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin can shrink tumors.

Who is the study for?

Adults aged 18-80 with aggressive Non-Hodgkin's Lymphoma that is resistant or has returned after treatment. They must have at least one measurable lesion, be in relatively good health (ECOG 0-2), and meet specific blood count criteria. Women of childbearing age need a negative pregnancy test and agree to use contraception.

What is being tested?

The trial tests if combining CAR-T Cell Therapy with Mosunetuzumab and Polatuzumab can shrink tumors in patients whose lymphoma didn't respond to previous treatments or came back after such treatments, including stem cell transplantation.

What are the potential side effects?

Potential side effects include immune system reactions, infusion-related symptoms, fatigue, organ inflammation, increased risk of infections, and possibly changes in blood counts. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

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

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I have at least one lymphoma lesion that can be measured.

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My condition is primary mediastinal B cell lymphoma.

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I have a type of high-grade B cell lymphoma, not B-lymphoblastic lymphoma.

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One of my lymphoma lesions is at least 1.5 cm in size.

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I am not pregnant or I am post-menopausal/have had a hysterectomy/oophorectomy.

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I am between 18 and 80 years old.

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My lymphoma cells are CD19 positive.

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I am able to get out of my bed or chair and move around.

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My lymphoma did not respond to initial treatment, has returned, or occurred after a stem cell transplant.

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My kidney function is good.

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My diagnosis is one of DLBCL, PMBCL, TFL, HGBL, MCL, or BL and it's covered by my insurance.

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I relapsed after my own stem cell transplant more than 3 months ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart disease.

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My high blood pressure is not under control.

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I do not have any disqualifying autoimmune conditions.

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I am not taking prednisone over 10 mg daily or other immune-weakening drugs.

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My lymphoma type does not lack CD19 and is not excluded due to its unique characteristics.

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I have an infection that is not responding to treatment.

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My lymphoma affects my brain or spinal cord.

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I have or might have a history of MAS/HLH or CAEBV.

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I haven't had a heart attack or major heart issues in the last 6 months.

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I have never received anti-CD19 CAR-T therapy.

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I don't have antibodies that cause issues with platelet transfusions.

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I am not on blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response Rate

Secondary study objectives

Duration of Response (DoR)

Minimal residual disease (MRD) negativity

Overall Response Rate (ORR)

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination CAR-T Cell Therapy, Mosunetuzumab + PolatuzumabExperimental Treatment3 Interventions

Participants will receive study treatment in three phases: Induction Phase, CAR-T Treatment Phase and Consolidation Phase. During the Induction Phase (Days -42, through -6), participants will receive Mosunetuzumab on Days -42, -35, -28, and -7; and Polatuzumab on Day -28. On Day -6, participants will be evaluated in clinic. During the CAR-T Treatment Phase (Days -5, through Day 0), participants will receive lymphodepleting chemotherapy for three consecutive days beginning on Day -5, followed by CAR-T Cell therapy via infusion on Day 0. During the Consolidation Phase (Days +1 through +90), participants will receive Mosunetuzumab on Day +14; and combination Mosunetuzumab and Polatuzumab on Days +35, +56 and +77.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mosunetuzumab

FDA approved

0 / 24Eligibility criteria met