Cell Therapy for CD7 Positive Acute Myeloid Leukemia or Mixed Lineage Leukemia

NCT04938115 | Completed

• 1 other identifier: CD7+ mixed lineage leukemia
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

Conditions

Leukemia, T Cell

Outcome Measures

Primary Outcomes (2)

• Safety: Incidence and severity of adverse events

  To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

  First 1 month post CAR-T cells infusion

• Efficacy: Remission Rate

  In the presence of extramedullary lesions, complete remission (CR), partial remission (PR), stable disease (SD), disease recurrence or progression (PD) shall be used to describe extramedullary lesions

  3 months post CAR-T cells infusion

Secondary Outcomes (7)

• duration of response (DOR)

  24 months post CAR-T cells infusion

• Efficacy: progression-free survival (PFS)

  24 months post CAR-T cells infusion

• CAR-T proliferation

  3 months post CAR-T cells infusion

• CAR-T proliferation

  3 months post CAR-T cells infusion

• Cytokine release

  First 1 month post CAR-T cells infusion

Study Arms (1)

CD7 CAR-T

EXPERIMENTAL

Biological: CD7 CART

Interventions

CD7 CART BIOLOGICAL

Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

CD7 CAR-T

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of refractory or relapsed CD7+ acute myeloid leukemia or mixed lineage leukemia was made according to the NCCN 2019.V2 guideline. Refractory AML is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed AML is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. Patient diagnosed with AML should be treated and whose disease failed with at least 2 prior lines of therapies. Patients whose tumor burden ≥5% blasts, or who have persistent positive minimal residual disease (MRD), or have reappearance of extramedullary lesions are also considered eligible;
• CD7+ expression on tumor cells (CD7 positive blasts ≥50% by flow cytometry);
• Life expectancy greater than 12 weeks;
• KPS or Lansky score≥60;
• HGB≥70g/L (can be transfused);
• oxygen saturation of blood\>90%;
• Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
• Informed consent explained to, understood by and signed by patient/guardian

You may not qualify if:

• Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)\<30% or LVEF(left ventricular ejection fraction)\<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
• Has an active GvHD;
• Has a history of severe pulmonary function damaging;
• With other tumors which is/are in advanced malignant and has/have systemic metastasis;
• Severe or persistent infection that cannot be effectively controlled；
• Merging severe autoimmune diseases or immunodeficiency disease;
• Patients with active hepatitis B or hepatitis C(\[HBVDNA+\]or \[HCVRNA+\]);
• Patients with HIV infection or syphilis infection;
• Has a history of serious allergies on Biological products (including antibiotics);
• Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6;
• Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;
• Have received transplant treatment for less than 6 months in prior to enrollment;
• Being pregnant and lactating or having pregnancy within 12 months;
• Any situations that the researchers believe will increase the risks for the subject or affect the results of the study

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

He bei Yan da Lu dao pei Hospital

Beijingcun, Hebei, China

Location

Related Publications (1)

• Lu P, Zhang X, Yang J, Li J, Qiu L, Gong M, Wang H, Chen J, Liu H, Xiong M, Liu Y, Wang L. Nanobody-based naturally selected CD7-targeted CAR-T therapy for acute myeloid leukemia. Blood. 2025 Mar 6;145(10):1022-1033. doi: 10.1182/blood.2024024861.

  PMID: 39561281 DERIVED

MeSH Terms

Conditions

Leukemia, T-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Peihua MD Lu, PhD

  Hebei Yanda Ludaopei Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: May 10, 2021
• Primary Completion: May 31, 2023
• Study Completion: October 30, 2023
• Last Updated: June 14, 2024

Record last verified: 2023-05

Locations

CN (1)