Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory/Relapsed AML

NCT07336875 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: TJ-IRB202512163
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of CAR-ITNK cells therapy targeting CD70 and CLL1 in participants with relapsed/refractory Acute Myeloid Leukemia. Participants will receive a single infusion of CAR-ITNK cell therapy targeting CD70 and CLL1 and complete follow-ups over the next three years.

Conditions

R/R AML

Keywords

CAR-ITNK; CD70&CLL1

Outcome Measures

Primary Outcomes (1)

• ORR

  The overall response rate (ORR) includes both complete response (CR) and partial response (PR), and uses the Clopper-Pearson method to calculate the two-sided 95% confidence interval.

  3 years

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Administer a single infusion of CAR-ITNK Cells targeting CD70 and CLL1 to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion, and conduct follow-up surveys at the required time points within three years post-infusion according to the visit schedule.

Biological: CAR-ITNK Cells targeting CD70 and CLL1

Interventions

CAR-ITNK Cells targeting CD70 and CLL1 BIOLOGICAL

Administer a single infusion of CAR-ITNK Cells targeting CD70 and CLL1 to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The patient or their legal guardian voluntarily participates and has signed the informed consent form.
• \. Age between 18 and 75 years old (inclusive), with no gender restrictions. 3. Diagnosed as having refractory/relapsed acute myeloid leukemia, meeting one of the following criteria:
• Reappearance of leukemic cells in peripheral blood after achieving complete remission, or bone marrow blast count \> 5% (excluding other causes such as bone marrow reconstitution post-consolidation chemotherapy), or the presence of extramedullary leukemic cell infiltration.
• Ineligible for bone marrow transplantation, or have undergone bone marrow transplantation but failed to achieve long-term remission.
• \. Expression of both CLL-1 and CD70 targets is confirmed as positive by flow cytometry.
• \. Patients must have good major organ function:
• Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L.
• Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min.
• Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection.
• Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, and no clinically significant ECG abnormalities.
• \. Women of childbearing age must have a negative urine/blood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion. Male subjects with reproductive capacity must agree to use effective barrier contraception for at least 1 year after infusion.
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. 8. Expected life expectancy greater than 3 months. 9. The patient is willing to cooperate with the collection of peripheral blood mononuclear cells, medical examinations, and regular follow-up visits.

You may not qualify if:

• The patient will be excluded if meeting any of the following criteria:
• Women who are pregnant or breastfeeding.
• Presence of uncontrolled fungal, bacterial, treponemal (e.g., syphilis), viral, or other infections.
• Active hepatitis B (Hepatitis B virus DNA \> 500 IU/mL) or a positive Hepatitis C virus RNA (HCV-RNA) test.
• Human Immunodeficiency Virus (HIV) infection, or syphilis infection.
• Previously received any form of gene therapy.
• The patient has an allergic constitution or is allergic to macromolecular biologics such as antibodies or cytokines.
• History of clinically significant central nervous system diseases, such as: epilepsy, hemiparesis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, or organic brain syndromes.
• Uncontrolled psychiatric illness.
• A history of drug abuse/addiction.
• Use of prohibited medications:
• (2). Radiotherapy/Chemotherapy:Receipt of radiotherapy or salvage chemotherapy for the study disease within 3 weeks prior to cell collection.
• (3). Use of immunosuppressive agents within 4 weeks prior to cell collection. (4). Participation in another clinical trial or receipt of a major non-diagnostic surgical procedure within 4 weeks prior to cell collection.
• (5). Use of alemtuzumab within 6 months, or cladribine/clofarabine within 3 months, prior to cell collection.

Sponsors & Collaborators

• Tongji Hospital: lead

Central Study Contacts

Jia Wei, Ph.D.

CONTACT

027-83662680; jiawei@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 13, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share