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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I relapsed after my own stem cell transplant more than 3 months ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response Rate
Secondary outcome measures
Duration of Response (DoR)
Minimal residual disease (MRD) negativity
Overall Response Rate (ORR)
+4 moreTrial 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
Find a Location
Who is running the clinical trial?
Lazaros LekakisLead Sponsor
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,649 Total Patients Enrolled
Lazaros Lekakis, MDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe heart disease.You have an immune system disorder that is not related to the study.I have at least one lymphoma lesion that can be measured.My high blood pressure is not under control.I do not have any disqualifying autoimmune conditions.My condition is primary mediastinal B cell lymphoma.I am not taking prednisone over 10 mg daily or other immune-weakening drugs.My lymphoma type does not lack CD19 and is not excluded due to its unique characteristics.I have an infection that is not responding to treatment.I am HIV positive but meet specific health conditions.My disease did not improve after 2 cycles of specific chemotherapy.You have uncontrolled mental health issues that affect your thinking or behavior.I haven't had certain cancer treatments recently.I have DLBCL with CD19 positivity and my insurance approves CAR-T therapy. PTLD is not my diagnosis.I have a type of high-grade B cell lymphoma, not B-lymphoblastic lymphoma.My lymphoma affects my brain or spinal cord.My cancer did not respond to initial treatment with specific drugs.One of my lymphoma lesions is at least 1.5 cm in size.I am not pregnant or I am post-menopausal/have had a hysterectomy/oophorectomy.My lymphoma has changed from one type to another, or I have a specific type of aggressive lymphoma.I have or might have a history of MAS/HLH or CAEBV.I haven't received blood transfusions or certain blood cell boosters in the last 5 days.I am between 18 and 80 years old.I have conditions that could make my brain more sensitive to side effects.I have relapsed or refractory Burkitt lymphoma and need new treatment options.My lymphoma cells are CD19 positive.I haven't had a heart attack or major heart issues in the last 6 months.I have never received anti-CD19 CAR-T therapy.I am able to get out of my bed or chair and move around.I don't have antibodies that cause issues with platelet transfusions.I have chronic hepatitis B or C, but it meets certain conditions.I have not had invasive cancer in the past 3 years, with some exceptions.My lymphoma did not respond to initial treatment, has returned, or occurred after a stem cell transplant.You cannot participate if you have had a solid organ transplant in the past.My kidney function is good.I am not on blood thinners.My diagnosis is one of DLBCL, PMBCL, TFL, HGBL, MCL, or BL and it's covered by my insurance.I relapsed after my own stem cell transplant more than 3 months ago.I have been diagnosed with Mantle Cell Lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Combination CAR-T Cell Therapy, Mosunetuzumab + Polatuzumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom does this trial offer its services?
"This clinical trial is admitting 40 people, between the ages of 18 and 80 who have diffuse lymphoma. It is important that patients also meet the following criteria: Diffuse large B cell lymphoma (DLBCL) not otherwise specified. Patients with primary cutaneous DLBCL of leg-type are eligible if the lymphoma expresses cluster of differentiation 19 (CD19) and if the insurance approves the CAR-T therapy. Similarly. Large cell transformation of nodal or extra-nodal marginal zone lymphoma is eligible only if the insurance allows and the disease shows strong CD19 positivity. On the other hand,"
Answered by AI
Is there a high risk associated with CAR-T Cell Therapy?
"CAR-T Cell Therapy is a Phase 2 treatment, which means that while there is some evidence supporting its safety, there is none yet backing its efficacy. We've given it a score of 2."
Answered by AI
Do you have an age limit for the volunteers in this research project?
"The age requirement for this clinical trial is 18-80, which is different from the 1659 trials meant for patients over 65 and the 332 trials designed for those under 18."
Answered by AI
Are investigators looking for more individuals to participate in this research project?
"According to the website clinicaltrials.gov, this trial is still looking for patients. The listing was created on November 1st, 2020 and updated as recently as October 19th, 2020."
Answered by AI
How many people are enrolled in this experiment?
"Indeed, the clinicaltrials.gov website reveals that this trial is currently enrolling patients. This study was originally posted on November 1st, 2022 and has been edited as recently as October 19th, 2022. The research team hopes to recruit 40 individuals from a single location."
Answered by AI
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