Phase 1 Study of Engineered NK Cells for Lymphoid Cancers
This study is testing a new treatment called TGFBR2 KO CAR27/IL-15 NK cells for people aged 18-75 with certain types of lymphoid cancers (B-NHL, HL, T-NHL, or B-ALL) that have returned or are not responding to standard treatments. These NK cells are a type of immune cell that has been engineered to better fight cancer. You would also receive chemotherapy drugs, Fludarabine and Cyclophosphamide, before the NK cells. The main goal is to see how safe this new treatment is and what side effects it might cause. Researchers will also look at how well it works to shrink tumors and how long the treatment stays in your body. This is a Phase 1 study, meaning it's an early stage of testing in humans.
- Study design
- This is a Phase 1 study planning to enroll 60 participants. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and side effects will be measured through study completion, which is an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07444632
Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies
Recruiting
PHASE1Ages 18–75InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~60 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:FludarabineTGFBR2 KO CAR27/IL-15 NK cellsCyclophosphamide
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Yago Nieto, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
B-NHL: Failure of \>/= 1 salvage line and failure of or ineligibility for CAR-T.
HL and T-NHL: Failure of \>/= 1 salvage line or prior SCT.
ALL: Active disease (\>5% of blasts or positive MRD at a level of \>0.1% measured by multiparameter flow cytometry) after ≥ 2 two lines of therapy. Patients with B-ALL must have either failed of or be ineligible for CAR-T cell therapy. Patients who have mutations for which there are FDA approved targeted therapies (i.e., BCR-ABL) must also have received at least one of such agents. 3. Expression of CD70 in the pre-enrollment sample \>/= 20% measured by immunohistochemistry or flow cytometry. 4. Measurable disease, defined by \>/= 1 histologically confirmed hypermetabolic lesion on PET/CT scan. 5. ECOG PS ≤ 2 (Karnofsky ≥60%). 6. Adequate blood counts (WBC \>/= 2K, HGB \>/= 8 g/dL, platelets \>/= 50K). 7. Creatinine clearance ≥ 30 ml/min. 8. ALT and/or AST ≤ 3 x ULN, and bilirubin and ALP ≤ 2 x ULN. 9. FEV1, FVC and DLCOc ≥ 50%. 10. LVEF ≥ 40%, without active arrythmias. 11. If female of child-bearing potential, she must not be pregnant or breastfeeding and required to have a negative urine or serum pregnancy test prior to enrollment. 12. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 13. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection still on treatment, they are eligible if they have an undetectable HCV viral load. 14. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. 15. Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 16. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. 17. The effects of CAR-NK cells on the developing human fetus are unknown. For this reason and because fludarabine and cyclophosphamide, as well as other therapeutic agents, used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence, see Appendix 1) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114).
This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received whole pelvic radiation therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control (see Appendix 1) are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide.
What this trial measures
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0