Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies
2 other identifiers
interventional
60
1 country
1
Brief Summary
This is a phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2026
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedStudy Start
First participant enrolled
August 31, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2030
Study Completion
Last participant's last visit for all outcomes
September 30, 2032
May 8, 2026
May 1, 2026
4.1 years
February 26, 2026
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year
Study Arms (2)
Cycle 1: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK Cells
EXPERIMENTALEach treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.
Cycle 2: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK Cells
EXPERIMENTALEach treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.
Interventions
Given by IV
Given by IV
Given by IV
Eligibility Criteria
You may qualify if:
- years of age.
- Diagnosis of relapsed B-NHL, HL, T-NHL, or B-ALL in refractory relapse, defined as:
- 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.
- Expression of CD70 in the pre-enrollment sample \>/= 20% measured by immunohistochemistry or flow cytometry.
- Measurable disease, defined by \>/= 1 histologically confirmed hypermetabolic lesion on PET/CT scan.
- ECOG PS ≤ 2 (Karnofsky ≥60%).
- Adequate blood counts (WBC \>/= 2K, HGB \>/= 8 g/dL, platelets \>/= 50K).
- Creatinine clearance ≥ 30 ml/min.
- ALT and/or AST ≤ 3 x ULN, and bilirubin and ALP ≤ 2 x ULN.
- FEV1, FVC and DLCOc ≥ 50%.
- LVEF ≥ 40%, without active arrythmias.
- 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.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- +14 more criteria
You may not qualify if:
- Lymphoma or ALL in CR with no measurable sites of disease.
- Major surgery \<4 weeks prior to first dose of study drug.
- Any other severe or uncontrolled disease or condition which mightincrease the risk associated with study participation.
- Any other malignancy known to be active, with the exception of treated cervical intraepithelial neoplasia and non-melanoma skincancer.
- Grade \>/= 3 non-hematologic toxicity from prior therapy that has notimproved to grade \</= 2.
- Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \>/=10,000 copies/mL, or \>/=2,000 IU/mL), or hepatitis C (detectable viral load by HCV RNA PCR).
- Active infection requiring parenteral antibiotics.
- HIV infection.
- Treatment within prior 2 weeks with any anti-cancer agent,investigational or approved.
- Active CNS involvement (untreatedparenchymal brain metastasis or positive cytology of cerebrospinal fluid).
- Life expectancy \</= 6 months.
- Active and uncontrolled neurological disorder.
- Patients receiving systemic steroid therapy at time of enrollment (physiological replacement doses are allowed) or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.
- Patients receiving immunosuppressive therapy.
- Patients who are receiving any other investigational agents.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yago Nieto, MD, PHD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2026
First Posted
March 3, 2026
Study Start (Estimated)
August 31, 2026
Primary Completion (Estimated)
September 30, 2030
Study Completion (Estimated)
September 30, 2032
Last Updated
May 8, 2026
Record last verified: 2026-05