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Kappa CD28 T Cells for Leukemia (CHARKALL Trial)
CHARKALL Trial Summary
This trial is testing a new treatment for patients with a type of cancer called NHL, Multiple Myeloma (MM) or CLL that has come back or has not gone away after treatment. The treatment is a gene transfer research study using special immune cells. The study is testing whether combining two different ways of fighting disease, antibodies and T cells, will be more effective than using either method alone.
CHARKALL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCHARKALL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CHARKALL Trial Design
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Who is running the clinical trial?
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- My tumor is located where it could block my airway if it grows.My Coombs test is negative and I have CLL.My cancer is a type of B-cell cancer or multiple myeloma with Kappa-light chain.I have no cancer history in the last 2 years, except for certain skin, breast, or cervix cancers.My kidney and liver tests are within normal limits.I have B-cell cancer with specific characteristics and have had at least one treatment including Rituximab.My T-cells are modified to fight cancer and show more than 15% CAR-Kappa expression.I agree to use effective birth control during and for 3 months after the study.Your bilirubin levels are not more than three times the normal limit.You have an autoimmune disease that is currently causing symptoms or needing treatment.I am currently taking antibiotics for an infection.I have heart problems that cause symptoms.I understand the risks and benefits of this study and have signed the consent form.You are expected to live for at least 12 more weeks.You do not have HIV.I have recovered from side effects of previous chemotherapy. I may be on PD1/PDL1 inhibitors if needed.You have had allergic reactions to products containing murine protein, or have recently taken experimental drugs or tumor vaccines in the past six weeks.Your white blood cell count is above 500 and your hemoglobin level is 7.0 or higher.Your AST (a liver enzyme) level is not extremely high.I am mostly able to care for myself but may need occasional help.My blood clotting tests are within normal limits.Your blood oxygen level is above 90% without needing extra oxygen.My kidney function is good.
- Group 1: Kappa CD28 T cells for B-CLL
- Group 2: Kappa CD28 T cells for B-cell lymphoma
- Group 3: Kappa CD28 T cells for myeloma
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants are partaking in this research endeavor?
"Affirmative. Per the information contained on clinicaltrials.gov, this trial is currently searching for participants and was first posted in July of 2009 with its latest update being made at the end of January 2022. 54 individuals are sought from two medical centres."
Is this research available to volunteers at the moment?
"Affirmative. Per the listings on clinicaltrials.gov, this study which first became available on July 1st 2009 is actively recruiting participants. 54 individuals need to be identified across two medical centres."
Has the FDA given its official authorization to utilize Kappa CD28 T cells?
"With limited evidence to support its safety and efficacy, our team at Power rated Kappa CD28 T cells with a score of 1."
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