Anti-CD33 CAR-T Cells for the Treatment of Relapsed/Refractory CD33+ Acute Myeloid Leukemia

NCT ID: NCT05445765

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-06-30

Brief Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD33 CAR-T cells in patients with relapsed and/or refractory, high risk hematologic malignancies.

Detailed Description

AML is a rapidly progressing blood cancer and treated by high-dose multi-agent chemotherapy potentially followed by hematopoietic stem cell transplantation. Despite such intensive therapies, which are often associated with considerable toxicities and even death, about 60-70% of AML patients still relapse. Furthermore, the five-year survival rate from AML remains at a dismal 27%. AML is composed mostly of CD33+ leukemic blast cells. Therefore, CD33 is a potential good target by CAR T cells.

Conditions

Relapsed and/or Refractory Acute Myeloid Leukemia; High Risk Hematologic Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anti-CD33 CAR T cells

Dose escalation phase: anti-CD33 CAR T cells will be transduced with a lentiviral vector to express anti-CD33 CARs

Group Type: EXPERIMENTAL

anti-CD33 CAR T cells

Intervention Type: BIOLOGICAL

Anti-CD33 CAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

Interventions

anti-CD33 CAR T cells

Anti-CD33 CAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Signed written informed consent; Patients volunteer to participate in the clinical trial;

2. Diagnosis is mainly based on the World Health Organization (WHO) 2008;

3. Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;

4. Leukemic blast cells express CD33 (CD33 positive by flow cytometry or immunohistochemistry ≥70%);

5. The expected survival period is greater than 12 weeks;

6. ECOG score ≤2;

7. Age 2-60 years old;

8. HGB≥70g/L (can be transfused);

9. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.

Exclusion Criteria

1. Patients declining to consent for treatment

2. Prior solid organ transplantation

3. One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;

4. History of severe pulmonary dysfunction diseases;

5. Severe infection or persistent infection cannot be effectively controlled;

6. Severe autoimmune disease or congenital immunodeficiency;

7. Active hepatitis;

8. Human immunodeficiency virus (HIV) infection;

9. Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iCar Bio Therapeutics

UNKNOWN

Sponsor Role: collaborator

iCell Gene Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peihua Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Hebei Yanda Lu Daopei Hospital

Locations

Hebei Yanda Lu Daopei Hospital

Langfang, Hebei, China

Countries

China

Central Contacts

Kevin Pinz, MS

Role: CONTACT

kevin.pinz@icellgene.com

6315386218

Facility Contacts

Peihua Lu, MD

Role: primary

peihua_lu@126.com

011-86-18611636171

Other Identifiers

ICG165-001

Identifier Type: -

Identifier Source: org_study_id