Actively Recruiting
A Phase I/II Study of CAR.70-Engineered IL15-Transduced Cord Blood-Derived NK Cells With TGF-beta Receptor 2 (TGFBR2) Knock Out in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Myeloid Malignancies
Led by M.D. Anderson Cancer Center · Updated on 2026-05-06
42
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical research study is to find the recommended safe dose of TGFBR2 KO CAR27/IL-15 NK cells that can be given to patients with relapsed/refractory disease. The safety and effectiveness of this treatment will also be studied.
CONDITIONS
Official Title
A Phase I/II Study of CAR.70-Engineered IL15-Transduced Cord Blood-Derived NK Cells With TGF-beta Receptor 2 (TGFBR2) Knock Out in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosis of relapsed or refractory AML or treated secondary AML with prior targeted therapy if applicable
- Diagnosis of intermediate to very-high risk MDS with >5% bone marrow blasts and failure or progression after hypomethylating agent treatment
- Diagnosis of CMML-1 or CMML-2 with >5% bone marrow blasts and failure or progression after hypomethylating agent treatment
- CD70 expression greater than 10% measured by immunohistochemistry or flow cytometry
- Performance status of 2 or less on the ECOG scale
- Adequate liver, heart, kidney, and lung function meeting specified laboratory and clinical criteria
- Ability and willingness to provide informed consent
- Willingness to consent to long-term follow-up
- Willingness to use effective contraception during and for 3 months after the study
You will not qualify if you...
- Active severe heart failure (grade III-V by New York Heart Association Criteria)
- Active serious infection not controlled by antibiotics
- Active central nervous system leukemia
- Known HIV infection unless well controlled with stable therapy
- Known hepatitis B or active hepatitis C infection unless viral load is undetectable
- Prior or concurrent cancers that may interfere with study participation unless approved by the investigator
- Use of calcineurin inhibitors within 2 weeks before the study
- Treatment with investigational or chemotherapy agents within 7 days before lymphodepletion unless fully recovered or rapidly progressive disease
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nicholas Short, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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