Not yet recruitingNCT05467202Updated Jul 20, 2022

Evaluate the Safety and Efficacy of CLL1 CAR-T in Patients With R/R AML

A Phase 1 interventional study of CLL1 CAR-T in AML, sponsored by Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 2 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Zhejiang University · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 2 Years to 70 Years
Sex: All

Study summary

This is an open label, phase I study to assess the safety and efficacy of CLL1 CAR-T in patients with relapsed and refractory acute myeloid leukemia

Conditions studied

In context

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
The expression of CLL1 in AML blast is positive ;
The patient has recovered from the toxicity of previous treatment;
ECOG score ≤ 2 and expected survival period is not less than 3 months;
Adequate organ function defined as:
AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;
Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception

Exclusion criteria

Exclusion Criteria:

Diagnosis of acute promyelocytic leukemia;
History or presence of a CNS disorder;
HBsAg or HBcAb are positive; HCV 、HIV and Syphilis antibody are positive, CMV DNA in peripheral blood is more than≥500 copies /mL;
History of severe hypersensitivity reaction;
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
History of organ transplant surgery;
Required systemic application of immunosuppressive or other drugs;
Auto-SCT within the 3 months before enrollment;
Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));
Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;
Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;
Live vaccine received within the ≤ 4 weeks before enrollment;
Persons with serious mental illness;
History of major surgical operations four weeks before enrollment;
History of alcoholism or substance abuse;
Was identified by the investigators as unsuitable to participate in the study

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Experimental
Treatment group
Dose Escalation:After enrollment ,Participants complete the PBMC apheresis,then complete the Lymphocyte clearance,and then receive the dose climning test: 3×10e6/kg，6 ×10e6/kg，9×10e6/kg. Dose Expansion:Participants receive a single dose (at the MTD determined).
Drug: CLL1 CAR-T

Interventions

DrugCLL1 CAR-T
A single infusion of autologous CLL1 CAR-T cells administered intravenously

What researchers measure

Primary outcomes

Evaluation of Safety
Count the Incidence of adverse events
Time frame: Up to 2 years after CLL1 CAR-T infusion
Changes in cytokine level after CLL1 CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CLL1 CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ.
Time frame: Up to 2 years after CLL1 CAR-T infusion

Secondary outcomes

Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Time frame: Up to 2 years after CLL1 CAR-T infusion
Partial response Rate (PRR)
Proportion of subjects who achieved a partial response (PR)
Time frame: Up to 2 years after CLL1 CAR-T infusion
Overall response Rate(ORR)
Proportion of subjects who achieved CR, CRi, or PR
Time frame: Up to 2 years after CLL1 CAR-T infusion

Other outcomes

Overall survival
Death from any cause from the beginning of cell transfusion
Time frame: Up to 2 years after CLL1 CAR-T infusion
Recurrence free survival (RFS)
From remission to relapse or death of the subject (including all causes), whether the subject relapsed or died is unknown until the date of the last follow-up examination.
Time frame: Up to 2 years after CLL1 CAR-T infusion
Event-free survival (EFS)
Counting from the beginning of cell transfusion until treatment failure, recurrence, or death (various causes). Subjects without any of these events were counted up to the last follow-up examination date. For patients without CR or CRi, EFS is calculated from the beginning of cell transfusion until disease progression or death. Based on the initial event.
Time frame: Up to 2 years after CLL1 CAR-T infusion
MRD negative rate
The rate of MRD negative subjects was determined by flow cytometry.
Time frame: Up to 2 years after CLL1 CAR-T infusion
Median BM Reduction
Changes of bone marrow primitive cells after cell transfusion from baseline.
Time frame: Up to 2 years after CLL1 CAR-T infusion
Percentage of subjects disengaged from transfusion
Percentage of baseline transfusion-dependent subjects who were discharged from transfusion after cell transfusion.
Time frame: Up to 2 years after CLL1 CAR-T infusion

Study locations

1 site

The First Affiliated Hospital, Zhejiang University
Hangzhou, China
- Mingming Zhang, MD · Contact · mingmingzhang@zju.edu.cn · 13656674208

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05467202
Lead sponsor: Zhejiang University
Responsible party: He Huang (Professor, Zhejiang University) — Principal investigator
First posted: Jul 20, 2022
Start date: Aug 1, 2022 (estimated)
Primary completion: Aug 2, 2024 (estimated)
Completion: Aug 2, 2025 (estimated)
Last update: Jul 20, 2022

Study contacts

Mingming Zhang, MD

Contact

mingmingzhang@zju.edu.cn

13656674208

He Huang, MD

principal investigator · The First Affiliated Hospital, Zhejiang University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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