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CAR T-cell Therapy
Genetically Modified T Cells for Chronic Lymphocytic Leukemia
Phase 1 & 2
Waitlist Available
Led By Jae Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have adequate cardiac function (LVEF ≥40%) as assessed by ECHO or MUGA scan within 1 month of treatment
Patients must have CD19+ B cell leukemia or lymphoma with relapsed or chemotherapy-refractory disease or evidence of residual disease following therapy confirmed at MSKCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether using a patient's own T cells, which have been treated in the lab, can help the body build an effective immune response to kill cancer cells.
Who is the study for?
This trial is for patients with specific B cell leukemias or lymphomas that have either returned after treatment or didn't respond to chemotherapy. They must be confirmed at MSKCC, expected to live more than 3 months, and meet certain health criteria like kidney function and blood counts.Check my eligibility
What is being tested?
The study tests if T cells from the patient, modified in a lab to target cancer cells, combined with cyclophosphamide chemotherapy can effectively kill cancer cells. It's conducted in two stages: an initial safety study followed by a larger efficacy study.See study design
What are the potential side effects?
Potential side effects may include immune system reactions due to modified T cells attacking normal tissue, typical chemo side effects like nausea and hair loss, increased infection risk, and possible organ damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart is strong enough for treatment (LVEF ≥40%).
Select...
My leukemia or lymphoma is not responding to chemotherapy and has CD19+ B cells.
Select...
My CLL diagnosis was confirmed through specific tests.
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My oxygen levels are 92% or higher without extra oxygen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety (phase I)
efficacy of the two CD19-targeted T cell methods (phase II)
Secondary outcome measures
Antileukemic effect
Comparison of in vivo survival of patients receiving genetically modified anti-CD19 T cells after T-cell infusion with vs without lymphodepleting therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with CLL or indolent B-cell lymphomaExperimental Treatment2 Interventions
The first stage is a standard 3-step phase I dose escalation trial to assess the safety of 19-28z CAR expressing autologous T cells with or without prior conditioning chemotherapy.Step 1, a cohort of pts will receive the lowest planned dose of 19-28z+ modified T cells. Step 2, a cohort of pts will receive cyclophosphamide conditioning chemotherapy followed by the lowest planned dose of 19-28z+ modified T cells. If less than 33% of pts in the cohort experience unanticipated dose-limiting toxicity,Step 3, a cohort of pts will be treated with the investigator's choice conditioning chemotherapy followed by the higher dose of 19-28z+ modified T cells. If less than 33% of pts in the initial cohort (Step 3) experience unanticipated dose-limiting toxicity, the cohort in Step 3 may be expanded to include up to 15 pts. In Step 3, an additional cohort of Waldenstrom's Macroglobulinemia (WM) pts will be treated with the investigator's choice conditioning chemotherapy followed by 19-28z+ T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
therapeutic autologous lymphocytes
2006
Completed Phase 2
~300
cyclophosphamide
1994
Completed Phase 3
~8140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,103 Total Patients Enrolled
1,512 Trials studying Leukemia
384,632 Patients Enrolled for Leukemia
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,570 Total Patients Enrolled
116 Trials studying Leukemia
9,292 Patients Enrolled for Leukemia
Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
14 Previous Clinical Trials
435 Total Patients Enrolled
10 Trials studying Leukemia
274 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart issues, including recent heart failure or heart attack.I have a type of low-grade B-cell blood cancer.My heart is strong enough for treatment (LVEF ≥40%).I have HIV, hepatitis B, or hepatitis C.My CLL has transformed into a more aggressive form.My leukemia or lymphoma is not responding to chemotherapy and has CD19+ B cells.My CLL diagnosis was confirmed through specific tests.My oxygen levels are 92% or higher without extra oxygen.I am not currently receiving treatment for any other cancer besides the one being studied.I need assistance with my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with CLL or indolent B-cell lymphoma
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.
Are there any available opportunities for participants to join this trial?
"Clinicaltrials.gov does not indicate that this trial is currently open for enrollment, as the last update was on November 18th 2022. However, there are over 2300 other clinical trials actively searching for participants at this point in time."
Answered by AI
Are there precedents of trials with autologous lymphocytes being used to treat disease?
"As of now, 816 investigations into the therapeutic effects of autologous lymphocytes are ongoing. Out of those trials 154 have reached Phase 3 status and can be found across 27824 clinical trial sites, with a notable concentration in Philadelphia, Pennsylvania."
Answered by AI
What medical issues can be treated with a therapeutic autologous lymphocyte infusion?
"Autologous lymphocytes are frequently used in the clinical management of multiple sclerosis. This same therapeutic approach has been utilized to treat certain forms of leukemia, mixed-cell type lymphoma, myelocytic acute conditions, and retinoblastomas."
Answered by AI
How many participants have been recruited for this medical experiment?
"This clinical trial is currently dormant. It was initially posted on March 21st, 2007 and last modified 18th November 2022. For those looking for other studies to participate in, there are 1,516 trials recruiting participants with leukemia as well as 816 therapeutic autologous lymphocyte studies actively accepting patients ."
Answered by AI
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