CAR-NK Cell Therapy for Blood Cancers
Trial Summary
What is the purpose of this trial?
To determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.
Will I have to stop taking my current medications?
You may need to stop some medications. You must be at least 3 weeks from your last cytotoxic chemotherapy and stop tyrosine kinase inhibitors or other targeted therapies at least three days before starting the trial's chemotherapy. The protocol does not specify other medications, so check with the trial team for guidance.
What data supports the effectiveness of the treatment CAR-NK Cell Therapy for Blood Cancers?
Research shows that NK cells (a type of immune cell) engineered to express IL-15 and a chimeric antigen receptor (CAR) can effectively target and kill cancer cells, such as those in leukemia and lymphoma, without causing harmful side effects like graft-versus-host disease. This approach has shown promising results in preclinical models, suggesting it could be a powerful treatment for blood cancers.12345
Is CAR-NK cell therapy generally safe for humans?
How is the CAR-NK cell treatment for blood cancers different from other treatments?
The CAR-NK cell treatment is unique because it uses natural killer (NK) cells from cord blood, which can target cancer cells without causing graft-versus-host disease (a condition where donor cells attack the recipient's body). This treatment is 'off-the-shelf', meaning it can be prepared in advance and used for multiple patients, unlike traditional CAR-T cell therapies that require customization for each individual.3781011
Research Team
chitra hosing
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults aged 18-80 with relapsed/refractory blood cancers like T-cell malignancies, mantle cell lymphoma, and chronic lymphocytic leukemia. They must have tried at least two treatments before, be in good physical condition (Karnofsky score >50%), not pregnant or breastfeeding, and willing to use birth control. Patients should not have severe ongoing side effects from past treatments or active infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepleting Chemotherapy
All patients receive lymphodepleting chemotherapy with Cyclophosphamide and Fludarabine
Treatment
Participants receive CAR.5/IL15-transduced CB-NK cells at various dose levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CAR.5/IL15-transduced CB-NK cells
- Cyclophosphamide
- Fludarabine Phosphate
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor