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CAR T-cell Therapy
CAR-T Cell Therapy for Lymphoma and Leukemia
Phase 1
Recruiting
Led By Saad J. Kenderian, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Demonstration of progressive or stable disease by PET/CT or CT criteria according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL2018) criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from a complete response (cr) or partial response (pr) noted as the objective status at any time after the start of cart19 infusion, assessed up to 15.5 years
Awards & highlights
Study Summary
This trial is studying a new treatment for B cell malignancies that have come back or have not responded to treatment.
Who is the study for?
Adults with certain types of B cell malignancies that have not responded to or have returned after treatment. They must have had multiple prior therapies, be in good physical condition, and meet specific blood count and organ function criteria. Pregnant or breastfeeding individuals are excluded, as well as those who can get approved CD19 CAR T-cell therapies elsewhere.Check my eligibility
What is being tested?
The trial is testing a new therapy where patients' own immune cells (T cells) are modified in the lab to target cancer more effectively. This involves adding a gene so these T cells can recognize and potentially kill cancerous B cells using the IC19/1563 treatment.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion of modified T-cells, changes in blood counts, increased risk of infections, and possibly autoimmune responses where the body's immune system might attack normal organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My tests show my leukemia is not getting better but not significantly worse.
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My cancer is a type of B cell malignancy that has come back or didn't respond to treatment.
Select...
My last treatment didn’t fully work according to my latest scans.
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I have a tumor larger than 1.5 cm or my blood test shows more than 5000 lymphocytes.
Select...
My condition is relapsed or refractory B-cell non-Hodgkin lymphoma.
Select...
I am using two effective birth control methods during and for 12 months after the study.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from a complete response (cr) or partial response (pr) noted as the objective status at any time after the start of cart19 infusion, assessed up to 15.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from a complete response (cr) or partial response (pr) noted as the objective status at any time after the start of cart19 infusion, assessed up to 15.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Duration of response (DOR)
Minimal residual disease (MRD)
Overall response rate (ORR)
+4 moreOther outcome measures
In vivo cellular kinetics profile of CAR19 cells
Length of stay in hospital
Serum/plasma levels of cytokines
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cyclophosphamide, fludarabine, IC19/1563)Experimental Treatment10 Interventions
Patients receive cyclophosphamide IV over 60 minutes and fludarabine IV over 30 minutes on days -5, -4, -3, or bendamustine IV over 10 minutes on days -4 and -3, and IC19/1563 IV on day 0. Patients also undergo bone marrow biopsy and aspiration, CT-PET or CT scans, MRI, and collection of blood and tissue samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Cyclophosphamide
1995
Completed Phase 3
~3770
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Fludarabine
2012
Completed Phase 3
~1100
Bendamustine
2015
Completed Phase 3
~2950
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,211 Previous Clinical Trials
3,766,973 Total Patients Enrolled
62 Trials studying Lymphoma
27,918 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,829 Total Patients Enrolled
1,381 Trials studying Lymphoma
382,306 Patients Enrolled for Lymphoma
Saad J. Kenderian, M.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any cancer treatments, except for certain allowed ones.I have had a heart attack.I had a stem cell transplant more than 100 days ago, with no ongoing GVHD or immunosuppression.I am not willing to use effective birth control methods.I am currently on treatment but can pause for leukapheresis after a specific period.I have unstable chest pain.I have severe heart failure.You have a certain type of leukemia called SLL or CLL and have previously received at least two lines of therapy, or have been taking a medication called ibrutinib for at least 6 months. You must also have measurable disease, certain blood counts, and normal liver and kidney function. Additionally, you must not have any major heart or lung problems, must not be pregnant or planning to become pregnant, and must be willing to provide blood samples for research and follow-up visits to the study site.I am fully active or can carry out light work.I have B-cell lymphoma that has not improved after at least two treatments.My tests show my leukemia is not getting better but not significantly worse.My cancer is a type of B cell malignancy that has come back or didn't respond to treatment.I haven't taken any experimental drugs within 14 days before my leukapheresis.My SLL or CLL cancer has returned after treatment.I had a stem cell transplant using my own cells less than 6 weeks ago.I have not received a live vaccine in the last 6 weeks.I have a history of seizures, stroke, memory disorders, balance issues, or autoimmune disease affecting my brain.I can get approved CD19 CAR T-cell therapy.I am a sexually active male willing to use contraception during and for 12 months after the study.I do not have a serious infection or have been on IV antibiotics in the last week.My last treatment didn’t fully work according to my latest scans.I've had at least 2 cancer treatments, one with anthracycline, unless I couldn't tolerate it.I've had at least two treatments or 6 months of a specific therapy for my condition.I have been cancer-free for 2 years, except for non-serious skin cancers or early-stage cancers that were treated.I have a serious heart condition.I haven't had serious heart issues in the last 6 months.I have a tumor larger than 1.5 cm or my blood test shows more than 5000 lymphocytes.My condition is relapsed or refractory B-cell non-Hodgkin lymphoma.I am using two effective birth control methods during and for 12 months after the study.My blood clotting tests are normal or managed well if I'm on blood thinners, with no recent serious clotting or bleeding issues.I have a condition that severely weakens my immune system.I am currently taking more than 20 mg/day of prednisone or an equivalent steroid.I have had a procedure to open blocked arteries in my heart.I am 18 years old or older.I have a tumor larger than 1.5 cm that can be measured on a CT scan.My kidney function, measured by creatinine clearance, is adequate.My bilirubin levels are within the normal range, or I have Gilbert's syndrome with acceptable levels.I understand the study drug's effects on unborn babies are unknown.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cyclophosphamide, fludarabine, IC19/1563)
Awards:
This trial has 1 awards, including:- 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.
Could you elaborate on other research conducted involving Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563?
"Currently, 889 clinical trials are in progress for Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563. Of those studies, 161 have reached Phase 3. While the main concentration of these research efforts is based out of Philadelphia, Pennsylvania there are a total 28443 sites running related medical experiments."
Answered by AI
How many participants are currently taking part in this experiment?
"Affirmative. Clinicaltrials.gov shows that this trial, which was initially listed on July 14th 2022 and last updated the same day, is actively seeking participants. The study requires 18 individuals from 1 site to join it."
Answered by AI
Are there still openings available in this research initiative?
"Yes, the data on clinicaltrials.gov confirms that this trial is actively enrolling patients. The experiment was first published on July 14th 2022 and has recently been updated, with 18 participants needed from 1 medical centre."
Answered by AI
To what maladies is Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563 usually prescribed?
"Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563 is a frequently utilized therapy for treating multiple sclerosis, as well as mixed cell type lymphoma, leukemia, myelocytic acute and retinoblastoma."
Answered by AI
Has the FDA sanctioned Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563 for use?
"This autologous anti-CD19 CAR expressing T lymphocyte IC 19/1563 has limited clinical data to demonstrate its safety and efficacy, thus receiving a score of 1."
Answered by AI
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