R/R AMLEarly Phase 1NCT07336875
Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory/Relapsed AML
A Early Phase 1 study testing CAR-ITNK Cells targeting CD70 and CLL1 in people with R/R AML, run by Tongji Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- R/R AML
- What is being tested?
- CAR-ITNK Cells targeting CD70 and CLL1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2026to 28 Feb 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The patient or their legal guardian voluntarily participates and has signed the informed consent form.
- 2. 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.
- 4. Expression of both CLL-1 and CD70 targets is confirmed as positive by flow cytometry.
- 5. Patients must have good major organ function:
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- . 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.
- 6. 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.
- 7. 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.
Who cannot join
- 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.
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- 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:
- (1). Hormones: Use of corticosteroids (prednisone ≥ 2 mg/kg or equivalent > 20 mg/day) within 2 weeks prior to cell collection. Recent or ongoing use of inhaled, topical, or non-absorbable steroids is not an exclusion criterion.
- (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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory/Relapsed Acute Myeloid Leukemia
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.
Read the detailed description
Acute myeloid leukemia (AML) is a hematological malignancy disease originating from the bone marrow, typically presenting with acute onset, and patients may experience symptoms such as anemia, bleeding, and infections. The main treatment modalities currently include chemotherapy, targeted drug therapy, and hematopoietic stem cell transplantation. In addition to its low cure rate, AML has a high recurrence rate, is prone to developing resistance to chemotherapy drugs, and can easily lead to severe side effects, such as infections and bone marrow suppression. Therefore, there is an urgent need to find new therapeutic approaches for treating acute myeloid leukemia.
The research team at Guangdong Zhaotai Cell Biotechnology Co., Ltd. has independently developed and constructed a novel tandem CAR-ITNK cell targeting CD70 and CLL1. In vitro cytotoxicity assay data show that the activity of the tandem CAR-ITNK cells targeting both CD70 and CLL1 (CAR70C1-ITNK) in killing CD70- and CLL1-overexpressing cells is stronger than that of single-targeted CAR-ITNK cells against either CD70 or CLL1. In vivo xenograft mouse models using THP-1 cells demonstrate that the ability of CAR70C1-ITNK cells to kill THP-1 cells is superior to that of single-targeted CD70 CAR-ITNK cells. These experimental data indicate the potential value of the novel tandem CAR-ITNK cells targeting CD70 and CLL1 in clinically treating patients with refractory/relapsed acute myeloid leukemia.
This clinical trial proposes to use the novel tandem CAR-ITNK cells targeting CD70 and CLL1 as an interventional measure for subjects with refractory/relapsed acute myeloid leukemia. After treatment with these novel tandem CAR-ITNK cells, the safety and preliminary efficacy will be evaluated through various assessment methods, including clinical symptom evaluation, biomarker testing, laboratory tests, imaging assessments, adverse event monitoring, and follow-up surveys.
- Conditions
- R/R AML
- Being tested
- CAR-ITNK Cells targeting CD70 and CLL1
- Keywords
- CAR-ITNK, CD70&CLL1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-ITNK Cells targeting CD70 and CLL1Biological
Administer a single infusion of CAR-ITNK Cells targeting CD70 and CLL1 to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: CAR-ITNK Cells targeting CD70 and CLL1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start28 Feb 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for R/R AMLStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Wei, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336875
- Sponsor's protocol ID
- TJ-IRB202512163
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory/Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07336875
- Acronym / sponsor ID
- TJ-IRB202512163
- Conditions
- R/R AML
- Keywords
- CAR-ITNK, CD70&CLL1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute myeloid leukemia (AML) is a hematological malignancy disease originating from the bone marrow, typically presenting with acute onset, and patients may experience symptoms such as anemia, bleeding, and infections. The main treatment modalities currently include chemotherapy, targeted drug therapy, and hematopoietic stem cell transplantation. In addition to its low cure rate, AML has a high recurrence rate, is prone to developing resistance to chemotherapy drugs, and can easily lead to severe side effects, such as infections and bone marrow suppression. Therefore, there is an urgent need to find new therapeutic approaches for treating acute myeloid leukemia.
The research team at Guangdong Zhaotai Cell Biotechnology Co., Ltd. has independently developed and constructed a novel tandem CAR-ITNK cell targeting CD70 and CLL1. In vitro cytotoxicity assay data show that the activity of the tandem CAR-ITNK cells targeting both CD70 and CLL1 (CAR70C1-ITNK) in killing CD70- and CLL1-overexpressing cells is stronger than that of single-targeted CAR-ITNK cells against either CD70 or CLL1. In vivo xenograft mouse models using THP-1 cells demonstrate that the ability of CAR70C1-ITNK cells to kill THP-1 cells is superior to that of single-targeted CD70 CAR-ITNK cells. These experimental data indicate the potential value of the novel tandem CAR-ITNK cells targeting CD70 and CLL1 in clinically treating patients with refractory/relapsed acute myeloid leukemia.
This clinical trial proposes to use the novel tandem CAR-ITNK cells targeting CD70 and CLL1 as an interventional measure for subjects with refractory/relapsed acute myeloid leukemia. After treatment with these novel tandem CAR-ITNK cells, the safety and preliminary efficacy will be evaluated through various assessment methods, including clinical symptom evaluation, biomarker testing, laboratory tests, imaging assessments, adverse event monitoring, and follow-up surveys.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Biological: CAR-ITNK Cells targeting CD70 and CLL1Administer 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. The patient or their legal guardian voluntarily participates and has signed the informed consent form.
- 2. 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.
- 4. Expression of both CLL-1 and CD70 targets is confirmed as positive by flow cytometry.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-ITNK Cells targeting CD70 and CLL1Administer a single infusion of CAR-ITNK Cells targeting CD70 and CLL1 to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion | Biological | Experimental Arm |
Primary outcome
ORR
Time frame: 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAR-ITNK Cells targeting CD70 and CLL1 in people with R/R AML, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Wei, Ph.D. (027-83662680 ext. 13986102084, jiawei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.