A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

NCT06880354 | Recruiting Phase 1

• 1 other identifier: IIT2024059
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual-target CAR T cell injection in r/r AML subjects.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity (DLT) Rate

  Proportion of subjects with DLT within 28 days after infusion of CLL1/CD38 dual-target CAR-T cell injection.

  28 days

• Adverse Events （AEs）

  Proportion of subjects experiencing AE within 96 weeks after infusion of CLL1/CD38 dual-target CAR-T cell injection.

  96 weeks

Secondary Outcomes (8)

• Complete Remission Rate (CRc)

  96 weeks

• Overall Response Rate (ORR)

  96 weeks

• MRD negative rate and MRD negative duration

  96 weeks

• Duration of Remission（DOR）

  96 weeks

• Event-free Survival (EFS)

  96 weeks

Study Arms (1)

Intervention（CLL1 and CD38 Dual-Target CAR-T Cell Injection）

EXPERIMENTAL

This study is a single-center open-label 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 enrolled subjects were patients with relapsed and refractory acute myeloid leukemia (r/r AML) .

Drug: CLL1 and CD38 Dual-Target CAR-T Cell Injection

Interventions

CLL1 and CD38 Dual-Target CAR-T Cell Injection DRUG

This product is a lentiviral gene-modified autologous chimeric antigen receptor T-cell product that targets both CLL1 and CD38.

Intervention（CLL1 and CD38 Dual-Target CAR-T Cell Injection）

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of signing the informed consent, 18-70 years old (including the critical value);
• Diagnosed with acute myeloid leukemia (except for APL) based on the World Health Organization (WHO) 2022 criteria and meeting the diagnostic criteria for relapsed/refractory AML (refer to the 2023 Chinese Guidelines for the Diagnosis and Treatment of relapsed refractory acute myeloid leukemia);
• Positive expression of CLL1 and/or CD38 in tumor cells;
• Estimated survival ≥3 months;
• Have a confirmed donor for allogeneic hematopoietic stem cell transplantation. After the CAR-T cells were infused, subjects could undergo potential allogeneic hematopoietic stem cell transplantation at any time;
• ECOG score of 0\~2 during the screening phase;
• Adequate functional reserve of organs:
• Alanine aminotransferase/aspartate aminotransferase ≤2.5× ULN;
• Total serum bilirubin ≤2× ULN, except in subjects with congenital bilirubinemia (direct bilirubin ≤1.5× ULN in subjects with Gilbert's syndrome);
• Serum creatinine clearance \> 45mL/min (calculated according to Cockcroft-Gault formula);
• Left ventricular ejection fraction (LVEF) ≥45%;
• Basal finger oxygen saturation ≥92% in room air.
• The ability to discontinue corticosteroids (dexamethasone ≥3mg/ day or other equivalent dose of hormones) from day 7 and continue until 30 days after CAR T cell infusion;
• Pregnant women of childbearing potential should be negative for HCG (immunofluorescence) tests during screening and baseline. Male subjects must agree not to donate sperm for at least two years after the infusion. Male subjects and his sexual partner with childbearing potential must agree to use highly effective contraception for at least 2 years after the infusion;
• Agree to follow-up in accordance with the protocol and the requirements outlined in the informed consent form;

You may not qualify if:

• Known allergy to any of the drug ingredients to be used in this study;
• With a history of the following concomitant treatments:
• Received a cumulative dose of prednisone (or equivalent corticosteroids). Greater than or equal to ≥ 70 mg within 7 days prior to apheresis;
• Based on the investigator's assessment, there is a comorbidity that requires the use of systemic corticosteroids (≥ 70 mg total dose of prednisone or equivalent doses of other corticosteroids) or other immunosuppressive medications within 12 weeks after the study treatment;
• Received systemic anti-tumor therapy within 14 days before apheresis or within five half-lives of the drug, whichever was shorter, including but not limited to cytotoxic therapy, targeted therapy, or an investigational drug treatment;
• Received radiotherapy 4 weeks before apheresis;
• Received donor lymphocyte infusion within 6 weeks before apheresis.
• Acute promyelocytic leukemia was diagnosed;
• Have previously been received CAR-T therapy, CAR-NK therapy or any other genetically modified cell therapy;
• Received allogeneic hematopoietic stem cell transplantation within 6 months before screening phase;
• Active graft-versus-host disease (GvHD) at the time of screening or active acute or chronic GvHD within 4 weeks of enrollment or the need for immunosuppressive drugs;
• An active infection that requires systemic treatment;
• Any history of active malignancy (excluding non-melanoma skin cancer, cervical carcinoma in situ, bladder cancer, breast cancer, or other similar cancers, with a disease-free survival period of more than 5 years and no signs of recurrence after curative treatment);
• Experienced a stroke or seizure within 6 months prior to signing the ICF;
• Presence of any heart diseases as follows:

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Gracell Biotechnologies (Shanghai) Co., Ltd.: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Ying Wang

CONTACT

022-23909095; wangying1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 3, 2025

Record last verified: 2025-01

Locations

CN (1)