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CAR T-cell Therapy

Kappa CD28 T Cells for Leukemia (CHARKALL Trial)

Phase 1
Recruiting
Led By Carlos Ramos, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If patient has CLL, must have negative Coombs test
B-CLL or recurrent or refractory B-cell lymphoma (or other B-cell neoplasm) or multiple myeloma monoclonal for Kappa-light chain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

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.

Who is the study for?
This trial is for patients with certain blood cancers (NHL, MM, CLL) that have relapsed or are treatment-resistant. Participants must be recovered from prior chemotherapy effects, not HIV positive, and willing to use effective birth control. They should have a life expectancy of at least 12 weeks and no recent history of other cancers or active infections.Check my eligibility
What is being tested?
The study tests kappa-CD28 T cells designed to fight cancer by combining antibodies with T lymphocytes. The highest safe dose found in earlier phases will be used. These engineered T cells carry an antibody that targets cancer cells and a protein (CD28) expected to enhance their longevity and effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's enhancement such as inflammation in various organs, symptoms due to the engineered T cells attacking normal tissues mistakenly (autoimmune-like responses), infusion-related reactions, fatigue, and increased risk of infection.

CHARKALL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Coombs test is negative and I have CLL.
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My cancer is a type of B-cell cancer or multiple myeloma with Kappa-light chain.
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I have no cancer history in the last 2 years, except for certain skin, breast, or cervix cancers.
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My kidney and liver tests are within normal limits.
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I have B-cell cancer with specific characteristics and have had at least one treatment including Rituximab.
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My T-cells are modified to fight cancer and show more than 15% CAR-Kappa expression.
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I agree to use effective birth control during and for 3 months after the study.
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I understand the risks and benefits of this study and have signed the consent form.
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I have recovered from side effects of previous chemotherapy. I may be on PD1/PDL1 inhibitors if needed.
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I am mostly able to care for myself but may need occasional help.
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My blood clotting tests are within normal limits.
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My kidney function is good.

CHARKALL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients with Dose-Limiting Toxicities (DLT)
Secondary outcome measures
To measure the anti-tumor effects of CAR-K+ T lymphocytes.
Other outcome measures
Survival and Function of CAR-K+ T cells

CHARKALL Trial Design

3Treatment groups
Experimental Treatment
Group I: Kappa CD28 T cells for myelomaExperimental Treatment1 Intervention
T cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes.
Group II: Kappa CD28 T cells for B-cell lymphomaExperimental Treatment1 Intervention
T cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes.
Group III: Kappa CD28 T cells for B-CLLExperimental Treatment1 Intervention
T cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
999 Previous Clinical Trials
6,001,843 Total Patients Enrolled
35 Trials studying Lymphoma
1,001 Patients Enrolled for Lymphoma
The Methodist Hospital Research InstituteOTHER
270 Previous Clinical Trials
80,194 Total Patients Enrolled
31 Trials studying Lymphoma
910 Patients Enrolled for Lymphoma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,763 Total Patients Enrolled
24 Trials studying Lymphoma
800 Patients Enrolled for Lymphoma

Media Library

Kappa CD28 T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00881920 — Phase 1
Lymphoma Research Study Groups: Kappa CD28 T cells for B-CLL, Kappa CD28 T cells for B-cell lymphoma, Kappa CD28 T cells for myeloma
Lymphoma Clinical Trial 2023: Kappa CD28 T cells Highlights & Side Effects. Trial Name: NCT00881920 — Phase 1
Kappa CD28 T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00881920 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~3 spots leftby Jan 2025