Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Aggressive T Cell Hematological Malignancies
2 other identifiers
interventional
70
1 country
1
Brief Summary
To determine the safety and efficacy (1-year PFS) of iC9/CD5CAR/IL-15 NK cells as consolidation in patients with aggressive T-cell malignances in first remission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2027
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2025
CompletedFirst Posted
Study publicly available on registry
August 22, 2025
CompletedStudy Start
First participant enrolled
February 28, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2030
Study Completion
Last participant's last visit for all outcomes
July 31, 2032
March 4, 2026
March 1, 2026
3.4 years
August 15, 2025
March 2, 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 (1)
Cohort 1 and Cohort 2: Treatment with Rituximab + iC9/CD5CAR/IL-15 NK Cells
EXPERIMENTALParticipants will recived treatment on an inpatient/outpatient basis at PI's discretion
Interventions
Given PO or IV
Given by IV
Given by IV
Eligibility Criteria
You may qualify if:
- years of age
- Patients with hematological malignancies with an expression of CD5 in the tumor sample of ≥ 30% measured by immunohistochemistry or flow cytometry.
- Patients must meet disease-specific eligibility criteria.
- a. Patients with a history of T-lymphoid malignancies, defined as T cell acute lymphoblastic leukemia/lymphoma (T-ALL/T-LBL), T-PLL, Peripheral T-cell lymphoma (PTCL-NOS), Hepatosplenic gamma/delta NHL, AITL, Alk negative/ DUSP22 negative ALCL, or other subtypes of T cell NHL with indication for autologous or allogeneic transplant in CR-1 Patients with T-ALL and T-PLL who are in morphologic remission but flow MRD positive are eligible.
- Patients should be at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy.
- Localized radiotherapy to one or more disease sites is allowed.
- Karnofsky Performance Scale \> 50%.
- Adequate organ function:
- Renal: Serum creatinine ≤ 2.0 ULN or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) ≥ 30 ml/min/1.73 m2.
- Hepatic: ALT/AST ≤ 3.0 x ULN or ≤ 5 x ULN if documented liver involvement with disease, Total bilirubin ≤ 2.0 ULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg/dL. No history of liver cirrhosis.
- Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease.
- Pulmonary: No clinically significant lung involvement, per PI discretion, pleural effusion, baseline oxygen saturation \> 92% on room air.
- Ability to understand and the willingness to sign a written informed consent document.
- Weight ≥40 kg.
- English and non-English-speaking patients are eligible.
- +7 more criteria
You may not qualify if:
- Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
- Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.
- Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.
- Active hepatitis B or C.
- HIV with detectable viral load.
- Presence of active neurological disorder(s).
- Active autoimmune disease within 12 months of enrollment
- Active cerebral or meningeal involvement by the malignancy
- Active (defined as requiring therapy) acute or chronic GVHD.
- Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
- Presence of any other serious medical condition that may endanger the patient at the investigator criteria.
- Major surgery \<4 weeks prior to first dose of study drug
- Allogeneic SCT or DLI \<12 weeks prior to first dose of study drug. Recipients of an allogeneic SCT patients should have discontinued all forms of immunosuppression at least 8 weeks prior to enrollment in the study.
- Concomitant use of other investigational agents.
- Concomitant use of other anti-cancer agents.
- +3 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
Chitra Hosing, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2025
First Posted
August 22, 2025
Study Start (Estimated)
February 28, 2027
Primary Completion (Estimated)
July 31, 2030
Study Completion (Estimated)
July 31, 2032
Last Updated
March 4, 2026
Record last verified: 2026-03