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CAR T-cell Therapy
CAR T-Cell Therapy for Lymphoma
Phase 1
Recruiting
Led By Mehrdad Abedi
Research Sponsored by Mehrdad Abedi, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses T-cells. The T-cells are taken from the blood and altered in a laboratory. They are then returned to the body. The altered T-cells will latch on to a specific part of the cancer cells and hopefully kill them.
Who is the study for?
Adults with relapsed or refractory diffuse large B-cell lymphoma who've had at least two prior therapies can join this trial. They must be in good health, able to take oral meds, and not use tobacco or drugs. Women of childbearing age and men must agree to effective contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of fludarabine and cyclophosphamide chemotherapy with or without rituximab before administering modified T-cells (CD19 CAR T-cell therapy) designed to target and kill lymphoma cells.See study design
What are the potential side effects?
Possible side effects include reactions from the immune system such as fever, weakness, infections due to low blood cell counts, nausea from chemotherapy drugs, potential allergic reactions to rituximab, and complications related to the infused CAR T-cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer is CD19 positive.
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My kidneys are functioning well, with a creatinine clearance rate of at least 50 cc/min.
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CD19 CAR T cell therapy is not available to me.
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I can take pills and will follow the study's treatment plan.
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I agree to not use tobacco or drugs during the study.
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I am mostly active and can carry out light work or activities.
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I haven't used any immune system reducing drugs around my treatment times.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities (DLTs) related to lymphodepleting chemotherapy and or CD19 CAR T cells
Incidence and severity of DLT associated with infusion of CD19 CAR T cells (infusion reactions)
T-Lymphocyte
+2 moreSecondary outcome measures
Complete response rate
Event free survival
Incidence of toxicities related to CD19 CAR T cells
+3 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Dose level 6 (rituximab, fludarabine, cyclophosphamide, CAR T)Experimental Treatment4 Interventions
Patients receive rituximab IV on day -5, fludarabine phosphate IV over 30 minutes daily on days -5 to -1, and cyclophosphamide IV over 60 minutes on days -5 and -4. Patients also receive CD19 CAR T cells IV on day 0.
Group II: Dose level 5 (fludarabine, cyclophosphamide, CD19 CAR T)Experimental Treatment3 Interventions
Patients receive fludarabine phosphate IV over 30 minutes daily on days -5 to -1 and cyclophosphamide IV over 60 minutes daily on days -5 and -4. Patients also receive CD19 CAR T cells IV on day 0.
Group III: Dose level 4 (rituximab, fludarabine, cyclophosphamide, CAR T)Experimental Treatment4 Interventions
Patients receive rituximab IV on day -5, fludarabine phosphate IV over 30 minutes daily on days -5 to -3, and cyclophosphamide IV over 60 minutes on day -5. Patients also receive CD19 CAR T cells IV on day 0.
Group IV: Dose level 3 (fludarabine, cyclophosphamide, CD19 CAR T)Experimental Treatment3 Interventions
Patients receive fludarabine phosphate IV over 30 minutes daily on days -3 to -5 and cyclophosphamide IV over 60 minutes daily on day -5. Patients also receive CD19 CAR T cells IV on day 0.
Group V: Dose level 2 (rituximab, fludarabine, cyclophosphamide, CAR T)Experimental Treatment4 Interventions
Patients receive rituximab IV on day -5, fludarabine phosphate IV over 30 minutes daily on days -5 to -3, and cyclophosphamide IV over 60 minutes on days -5 to -3. Patients also receive CD19 CAR T cells IV on day 0.
Group VI: Dose level 1 (fludarabine, cyclophosphamide, CD19 CAR T)Experimental Treatment3 Interventions
Patients receive fludarabine phosphate IV over 30 minutes daily and cyclophosphamide IV over 60 minutes daily on days -5 to -3. Patients also receive CD19 CAR T cells IV on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Rituximab
1999
Completed Phase 4
~1880
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Find a Location
Who is running the clinical trial?
Mehrdad Abedi, MDLead Sponsor
3 Previous Clinical Trials
32 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,818 Total Patients Enrolled
Mehrdad AbediPrincipal InvestigatorUniversity of California, Davis
4 Previous Clinical Trials
81 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diffuse large B cell lymphoma that didn't fully respond to at least two treatments including an anthracycline and an anti-CD20 drug.It's been over 2 weeks since my last cancer treatment before leukapheresis, except for recent radiotherapy or steroids.I have not had a fever in the 3 days before starting my immune system lowering therapy.I have hepatitis but my PCR test for it is negative.I had my own cells transplanted within 6 weeks or received a donor's cells within 3 months before planned CAR T cell therapy.My bone marrow biopsy before starting treatment showed myelodysplasia.I am 18 years old or older.My cancer is CD19 positive.I have an autoimmune disease that has caused organ damage or needed strong medication in the last 2 years.My kidneys are functioning well, with a creatinine clearance rate of at least 50 cc/min.My white blood cell count is low, but it's due to my condition.I do not have active brain tumors or cancer in the lining of my brain and spinal cord.I am not pregnant or breastfeeding and agree to use birth control during and after the study.I do not have any severe illnesses that would stop me from following the study's requirements.I am willing and able to follow all study rules and attend all appointments.CD19 CAR T cell therapy is not available to me.I can take pills and will follow the study's treatment plan.I am 18 years old or older.I am a man who can father children and will use contraception.I agree to not use tobacco or drugs during the study.I am mostly active and can carry out light work or activities.I have had cancer before, but it was not skin cancer or a very early stage cancer.My liver tests are within the required limits.I am allergic to components in the CAR T cell therapy.I haven't used any immune system reducing drugs around my treatment times.
Research Study Groups:
This trial has the following groups:- Group 1: Dose level 4 (rituximab, fludarabine, cyclophosphamide, CAR T)
- Group 2: Dose level 5 (fludarabine, cyclophosphamide, CD19 CAR T)
- Group 3: Dose level 2 (rituximab, fludarabine, cyclophosphamide, CAR T)
- Group 4: Dose level 3 (fludarabine, cyclophosphamide, CD19 CAR T)
- Group 5: Dose level 6 (rituximab, fludarabine, cyclophosphamide, CAR T)
- Group 6: Dose level 1 (fludarabine, cyclophosphamide, CD19 CAR T)
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.
Is enrollment for this experiment available at present?
"According to clinicaltrials.gov, this research endeavour is actively enrolling participants as it first appeared on September 17th 2021 and has since been updated in March 8th 2022."
Answered by AI
What is the scope of subjects involved in this medical experiment?
"Yes, the information on clinicaltrials.gov affirms that this trial is actively recruiting participants. The initial posting occurred on September 17th 2021 and was recently amended on March 8th 2022. To date, 36 volunteers are needed from a single medical site."
Answered by AI
What medical conditions is Chimeric Antigen Receptor T-Cell Therapy typically employed to treat?
"Chimeric Antigen Receptor T-Cell Therapy is frequently utilized to battle lung cancer. This form of treatment has been seen to be beneficial for conditions such as multiple sclerosis, some b-cell lymphomas, and polyangium."
Answered by AI
Has the FDA sanctioned Chimeric Antigen Receptor T-Cell Therapy?
"The safety profile of Chimeric Antigen Receptor T-Cell Therapy is assigned a score of 1, due to it currently being in the early stages of testing with limited data pertaining to its efficacy and safeness."
Answered by AI
What are the expected outcomes of this research endeavor?
"This two-month clinical trial is primarily assessing Maximum tolerated dose. Secondary objectives include the incidence of toxicities related to CD19 CAR T cells, event free survival and complete response rate which will be evaluated through logistic regression analysis, Kaplan and Meier methods as well as frequency tables. Log-rank tests are also employed for comparison between important subgroups in terms of time-to-event endpoints."
Answered by AI
Are there any prior investigations that have assessed the efficacy of Chimeric Antigen Receptor T-Cell Therapy?
"Currently, there are 1155 ongoing clinical trials for Chimeric Antigen Receptor T-Cell Therapy and 222 of them have entered Phase 3. Notably, the majority of these studies take place in Philadelphia but they span across 36790 locations globally."
Answered by AI
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