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Acute Myeloid LeukemiaEarly Phase 1NCT06110208

Study to Evaluate the Safety and Preliminary Efficacy of CLL1 and CD38 Dual CAR-T in r/r AML

A Early Phase 1 study testing CLL1 and CD38 dual-target CAR-T injection in people with Acute Myeloid Leukemia, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a single-center clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The included population were patients with relapsed and refractory acute myeloid leukemia (r/r AML) . Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
CLL1 and CD38 dual-target CAR-T injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteChina
Study dates
10 Oct 2023to 1 Jul 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 years old (including the critical value) when signing the informed consent form;
  • Diagnosed with acute myeloid leukemia (excluding APL) according to the World Health Organization 2016 criteria and relapsed and refractory AML according to the ELN2022 criteria;
  • Positive expression of CLL1 and/or CD38 in malignant cells must be detected by immunohistochemistry or flow cytometry (≥20 % );
  • If there are AEs caused by previous chemotherapy, it must be restored to CTCAE V5.0 grade 1;
  • Estimated survival time ≥3 months;
  • ECOG score 0 or 1 during screening period;
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  • Hemoglobin ≥80g/L (have not received red blood cell transfusion within 7 days before screening, use of recombinant human erythropoietin is allowed);
  • Adequate organ functional reserve:
  • Alanine aminotransferase/aspartate aminotransferase ≤2.5× ULN (upper limit of normal value);
  • Serum total bilirubin ≤2× ULN, except for subjects with congenital bilirubinemia (for subjects with Gilbert syndrome, direct bilirubin needs to be ≤1.5× ULN);
  • Serum creatinine clearance >45mL/min (calculated according to the Cockcroft-Gault formula);
  • Left ventricular ejection fraction ≥35%;
  • Basic oxygen saturation in indoor air environment is ≥ 92 %
  • Ability to discontinue corticosteroids (dexamethasone ≥3 mg/day or other equivalent doses of steroids) starting on day -7 and continuing until 30 days after CAR-T cell infusion;
  • Women of childbearing age must have a negative pregnancy test for human chorionic gonadotropin (HCG) (immunofluorescence method) during the screening period and baseline period. Male subjects will need to agree not to donate sperm for at least one year after reinfusion. Males and sexual partners of childbearing potential agree to use highly effective contraceptive measures for at least 1 year after infusion;
  • Agree to perform follow-ups in accordance with the requirements of the protocol and informed consent form;
  • With the consent of the subject and the informed consent form voluntarily signed by the subject or his legal representative.

Who cannot join

  • Diagnosis of acute promyelocytic leukemia;
  • clinical trial investigational drugs or cell therapies within 2 weeks or 5 half-lives ;
  • Acute myeloid leukemia of unknown lineage ;
  • Those who have active graft-versus-host disease (GVHD) at the time of enrollment or develop active acute or chronic GVHD within 4 weeks after enrollment or require immunosuppressive drugs to treat GVHD;
  • There is an active infection;
  • Suffering from other malignant tumors (except non-melanoma skin cancer and in situ cervical cancer, bladder cancer, and breast cancer with a disease-free survival period of more than 5 years);
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  • The subject has had a stroke or epilepsy within 6 months before signing the informed consent form;
  • The subjects' cardiac function showed the following conditions:
  • New York Heart Association (NYHA) class III or IV heart failure;
  • Myocardial infarction or coronary artery bypass grafting (CABG) occurred within 6 months before signing the informed consent form;
  • A history of clinically significant ventricular arrhythmia or syncope of unknown origin (not caused by vasovagal or dehydration);
  • Have a history of severe non-ischemic cardiomyopathy;
  • Cardiac dysfunction (left ventricular <35%) assessed by echocardiography or multiple gated acquisition scans, or other heart disease with clinical symptoms within 6 months before enrollment;
  • Active or previous central nervous system involvement, or clinically significant clinical manifestations of central nervous system involvement in subjects with acute myeloid leukemia ;
  • A positive virological test result for any of the following:
  • Human immunodeficiency virus antibodies (HIV antibodies);
  • Hepatitis C virus antibody (HCV antibody), those who are positive need to be tested for HCV-RNA, and those whose values are lower than the lower limit of the detection value can be enrolled;
  • HBsAg positive; or HBcAb positive; if HBcAb is positive, further testing of HBV DNA copy number is required . Those who are lower than the lower limit of the detection value can be enrolled;
  • Treponema pallidum antibodies (TPPA antibodies);
  • presence of pulmonary fibrosis;
  • Severe allergic history or allergic constitution;
  • The subject has undergone open injury or major surgery (referring to level III surgery and level IV surgery) within 2 weeks before signing the informed consent form, or plans to have surgery during the trial or within 2 weeks after reinfusion (excluding local anesthesia surgery) ;
  • for cyclophosphamide combined with fludarabine ;
  • Cannulae or drains other than central venous catheters;
  • Pregnant women, lactating women, or men who plan to give birth within 1 year of receiving treatment;
  • Any other circumstances that the researcher deems inappropriate for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • 920th Hospital of Joint LogisticsSupport Force of People's Liberation

    Kunming, Yunnan, 650000

Other trials in China

About this study

Official title: Clinical Study to Evaluate the Safety and Preliminary Efficacy of CLL1 and CD38 Dual CAR-T Injection in the Treatment of Relapsed and Refractory Acute Myeloid Leukemia

This study is a single-center clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The included population were patients with relapsed and refractory acute myeloid leukemia (r/r AML) .

Read the detailed description

Single-center clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The included population was patients with relapsed and refractory acute myeloid leukemia (r/r AML) .

Being tested
CLL1 and CD38 dual-target CAR-T injection
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLL1 and CD38 dual-target CAR-T injectionDrug

    CLL1 and CD38 dual-target CAR-T injection

Study groups in NCT06110208
Study groupRoleWhat they receive
AML subjectsExperimentalThis study is a single-center clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The included population was patients with relapsed and refractory acute myeloid leukemia (r/r AML) .
Receives: Drug: CLL1 and CD38 dual-target CAR-T injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limited toxicity (DLT);

    Dose limited toxicity (DLT);

    Measured: 28 days after CAR-T infusion

  2. Adverse events (AE)

    • Adverse events (AE): CTCAE version 5.0 standards will be used for rating

    Measured: 48 weeks after CAR-T infusion

Secondary outcomes (14)

  1. • Overall response rate (ORR);

    defined as the proportion of subjects who achieved CR, CR with partial hematologic recovery(CRh), CR with incomplete hematologic recovery (CRi), morphologic leukemia-free status (MLFS), or partial remission (PR).

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  2. • Overall complete response rate (CRR);

    defined as the proportion of subjects who achieved morphological complete response (CR),CR with partial hematologic recovery(CRh) and complete response with incomplete hematological recovery ( CRi ).

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  3. • Partial response rate (PRR);

    defined as the proportion of subjects achieving partial response (PR).

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  4. • The proportion of patients who achieved complete remission (CR) who tested negative for MRD (MRD-rate);

    only used to evaluate subjects who achieve CR,CRh and CRi . In this study, the proportion of MRD-negative subjects was detected by flow cytometry. Sensitivity is defined as: collecting 100,000 nucleated cells in a bone marrow sample, of which the number of leukemia cells is less than 10 (i.e., MRD level <10 -4 ). Response with MRD detection at low-level (CRMRD-LL) is included in this category of CR, CRh or CRi with MRD-negative. CRMRD-LL is currently only defined for NPM1-mutant and CBF-AML

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  5. • Median bone marrow blast percentage decline;

    Median bone marrow blast percentage decline;

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  6. • Relapse-free survival (RFS);

    defined only for patients achieving CR, CRh, or CRi; measured from the date of achievement of remission until the date of hematologic relapse or death from any cause; patients not known to have relapsed or died at last follow-up are censored on the date they were last known to be alive.

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  7. • Event-free survival (EFS);

    used to evaluate all subjects . It is calculated from the start of cell infusion until treatment failure, relapse or death (various reasons). Subjects without the above events will be counted until the last follow-up examination date. For patients who did not achieve CR/CRh/ CRi , EFS was calculated from the start of cell infusion until disease progression or death. The first event shall prevail.

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  8. • Overall survival (OS);

    used to evaluate all subjects. The time from cell infusion to death from any cause was calculated.

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  9. • Duration of response (DOR);

    refers to the time from the first evaluation of CR, CRh, CRi , MLFS or PR to the first evaluation of disease recurrence or progression or death from any cause.

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  10. • Expansion and persistence of CAR-T cells (CAR copy number and CAR - T cell number)

    CAR copy number and CAR - T cell number

    Measured: Days 4, 7, 10, 14 ,21,28 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion

  11. • The proportion of subjects with RCL detected in peripheral blood and the insertion site of CAR-T cell lentivirus within 15 years after the infusion of CLL1 and CD38 dual-target CAR-T injection.

    • The proportion of subjects with RCL detected in peripheral blood and the insertion site of CAR-T cell lentivirus within 15 years after the infusion of CLL1 and CD38 dual-target CAR-T injection.

    Measured: within 15 years after the infusion of CLL1 and CD38 dual CAR-T injection

  12. • CR with partial hematologic recovery rate (CRhR);

    defined as the proportion of subjects who achieved CR with partial hematologic recovery.

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  13. • CR with incomplete hematologic recovery rate (CRiR);

    defined as the proportion of subjects who achieved CR with incomplete hematologic recovery

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

  14. • Morphologic leukemia-free state rate (MLFSR);

    defined as the proportion of subjects who achieved Morphologic leukemia-free state

    Measured: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2023
  2. Study start10 Oct 2023
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Why it stopped: Collaborator's decision

Resources

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06110208
Sponsor's protocol ID
GC12-132
Status last verified
Feb 2025
First submitted
26 Oct 2023
Last updated
26 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CLL1 and CD38 dual-target CAR-T injection in people with Acute Myeloid Leukemia, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.

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 17 inclusion and 26 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: stopped early, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study was stopped early (reason given: Collaborator's decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limited toxicity (DLT); (time frame: 28 days after CAR-T infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06110208.

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 26 Feb 2025.

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