Kappa-CD28 T Lymphocytes, Chronic Lymphocytic Leukemia, B-cell Lymphoma or Multiple Myeloma, CHARKALL

Launched by BAYLOR COLLEGE OF MEDICINE · Apr 14, 2009

Keywords

ClinConnect Summary

The CHARKALL clinical trial is studying a new treatment for patients with certain types of cancer, specifically non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia, that have either returned after treatment or did not respond to standard therapies. This trial is testing a special type of immune cell that has been modified to attack cancer cells more effectively. The researchers are combining two methods of fighting cancer: antibodies, which are proteins that can identify and attach to cancer cells, and T cells, which are blood cells that fight infections and can kill cancer cells. By combining these two approaches, they hope to create a more powerful treatment that lasts longer and works better.

To participate in this trial, patients must be between 65 and 74 years old and have specific types of cancer that meet certain criteria. For example, they should have measurable disease after at least one prior chemotherapy treatment and a life expectancy of at least 12 weeks. Participants will receive the highest safe dose of the modified immune cells and will be closely monitored for safety and effectiveness. It’s important to note that this treatment is still being researched and is not yet approved by the FDA. Patients interested in joining should discuss it with their doctors and understand the possible benefits and risks involved.

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• BLOOD PROCUREMENT:
• • B-CLL or recurrent or refractory B-cell lymphoma (or other B-cell neoplasm) or multiple myeloma monoclonal for Kappa-light chain
• • Life expectancy of at least 12 weeks or greater.
• • No history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry
• • If requires pheresis to collect blood, Cre and AST less than 1.5 upper limit of normal
• • If requires pheresis to collect blood, PT and PTTK less than 1.5 upper limit normal
• T CELL TREATMENT:
• Diagnosis of:
• 1. B-CLL monoclonal for Kappa light chain with one of the following criteria:
• • 1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
• • 2. Massive (ie, at least 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
• • 3. Massive nodes (ie, at least 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
• • 4. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months.
• 5. Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs:
• • 1. Unintentional weight loss of 10% or more within the previous 6 months;
• • 2. Significant fatigue (ie, ECOG PS 2 or worse; inability to work or perform usual activities);
• • 3. Fevers higher than 100.5°F or 38.0°C for 2 or more weeks without other evidence of infection; or
• • 4. Night sweats for more than 1 month without evidence of infection.
• • 5. Patients who have resistant disease after primary treatment
• • 6. Patients who have a short time to progression after the first treatment (less than 2 years)
• • OR
• • 2. Indolent or aggressive B-cell lymphoma (or other B-cell neoplasm) monoclonal for Kappa-light chain with measurable disease after receiving at least one chemotherapy regimen that includes Rituximab or an equivalent monoclonal antibody
• • OR
• • 3. Multiple myeloma monoclonal for Kappa-light chain with measurable disease after receiving at least one chemotherapy regimen
• • Life expectancy of at least 12 weeks or greater.
• • Recovered from the toxic effects of all prior chemotherapy before entering this study. PD1/PDL1 inhibitors will be allowed if medically indicated
• • ANC \> 500, Hgb greater than or equal to 7.0.
• • Bilirubin less than 3 times the upper limit of normal.
• • AST less than 5 times the upper limit of normal.
• • Estimated GFR \> 50mL/min
• • Pulse oximetry of \> 90% on room air
• • Karnofsky score of \> 60%.
• • Negative serology for HIV.
• • Available autologous transduced peripheral blood T-cells with 15% or more expression of CAR-Kappa determined by flow-cytometry.
• • Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients will be given a copy of the consent form.
• • Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.
• • If patient has CLL, must have negative Coombs test.
• EXCLUSION CRITERIA:
• BLOOD PROCUREMENT:
• • Active infection requiring antibiotics
• • Active autoimmune disease
• T CELL TREATMENT:
• • Symptomatic cardiac disease.
• • History of hypersensitivity reactions to murine protein-containing products. Currently receiving any investigational agents within the previous six weeks or received any tumor vaccines within the previous 6 weeks.
• • Tumor in a location where enlargement could cause airway obstruction.
• • Pregnant or lactating.