Actively Recruiting
Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells with Lymphodepleting Chemotherapy for Relapsed/Refractory Hematological Malignancies
Led by M.D. Anderson Cancer Center · Updated on 2026-02-02
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and best dose of CAR 5/IL15-transduced cord blood-derived natural killer (CB-NK) cells in patients with relapsed or refractory T-cell cancers, mantle cell lymphoma, and chronic lymphocytic leukemia. This Phase I/II study aims to find the optimal dose and effectiveness of these engineered immune cells for each specific disease. The study also seeks to understand how long the infused cells last in the body and how the immune system recovers after treatment. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine before getting the CAR.5/IL15-transduced CB-NK cells. The Phase 1 part tests four different cell dose levels ranging from 1 x 10^7 to 1 x 10^10 cryopreserved cells given through an intravenous infusion to find the safest and most effective dose. In Phase 2, patients will be randomly assigned to receive one of the two best doses determined in Phase 1, alongside the same chemotherapy regimen. During the study, participants will be closely monitored for treatment-related side effects using established criteria over about one year. Researchers will perform immune system tests and track how well the infused cells persist. Patients will undergo regular assessments including physical exams, lab tests, and imaging as needed. Participants must provide informed consent and agree to long-term follow-up to help understand the therapy's impact over time.
CONDITIONS
Brief Title
Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hematological malignancies expressing CD5 in at least 30% of tumor cells by immunohistochemistry or flow cytometry
- Meet disease-specific eligibility criteria for T-cell lymphoma, chronic lymphocytic leukemia, or mantle cell lymphoma
- At least one week since last cytotoxic chemotherapy before starting lymphodepleting chemotherapy
- Localized radiotherapy allowed before infusion if other disease sites are present
- Karnofsky Performance Scale score above 50%
- Adequate organ function including kidney, liver, heart, and lung as defined by specific lab and clinical measures
- Able to provide written informed consent
- Age between 18 and 80 years
- Weight at least 40 kg
- All language speakers eligible
- Effective birth control required during study and for 3 months after for those able to have children
- Signed consent for long-term follow-up
- Specific disease criteria: at least two prior therapy lines for T-cell malignancies, CLL/SLL, or mantle cell lymphoma with persistent or relapsed disease
You will not qualify if you...
- Positive pregnancy test or lactating females
- Grade 3 or higher toxicity from previous treatment
- Uncontrolled infections not responding to therapy
- Active hepatitis B or C infection
- Detectable HIV viral load
- Active neurological disorders
- Active autoimmune disease within past 12 months
- Active brain or meningeal cancer involvement
- Active acute or chronic graft versus host disease requiring therapy
- Other active malignancies except treated cervical intra-epithelial neoplasia or non-melanoma skin cancer
- Serious medical conditions endangering patient per investigator
- Major surgery within 4 weeks before first dose
- Recent allogeneic stem cell transplant or donor lymphocyte infusion within 12 weeks
- Current use of other investigational or anti-cancer agents
- Systemic steroid therapy at time of NK cell infusion (except physiologic doses)
- Recent use of immune globulins or alemtuzumab within defined timeframes
- Receiving immunosuppressive therapy
- Diminished mental capacity preventing consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 5 days
Participants receive lymphodepleting chemotherapy with Cyclophosphamide and Fludarabine administered by IV to prepare for NK cell infusion.
Daily visits for chemotherapy administration
Duration - 1 day
Participants receive a single infusion of CD5 CAR engineered IL15-transduced cord blood-derived NK cells.
1 visit (in-person) for NK cell infusion
Duration - Up to 1 year
Participants are monitored for safety, tolerability, and response to treatment, including immune system studies and adverse event assessment.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Chitra Hosing
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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