Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with hematopoietic and lymphoid malignancies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Pudong Hospital
• Collaborator: UTC Therapeutics Inc.
• Treatments: Cyclophosphamide; Fludarabine

Criteria

Inclusion Criteria:

1. Ability to understand and the willingness to sign informed consent.

2. Patients with relapsed or refractory Acute Myeloid Leukemia (AML), B-cell Non-Hodgkin's Lymphoma (B-NHL), Multiple Myeloma (MM), Adult T-cell Leukemia/Lymphoma (ATL), B-cell Acute Lymphoblastic Leukemia (B-ALL) after at least two cycles of first-line therapy or autologous hematopoietic stem cell transplantation (auto-HSCT).

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.

4. Adequate organ functions:

• Sufficient bone marrow function evaluated by investigator to receive lymphodepleting preparative regimen;

• Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance rate (as estimated by Cockcroft Gault) > 30 mL/min/1.73 m^2;

• Alanine aminotransferase (ALT) ≤ 5×ULN; and total bilirubin (TBIL) <2.0mg/dL; TBIL of patients with Gilbert's Syndrome or liver involvement must less than 3.0 mg/dL;

• Left ventricular ejection fraction (LVEF) > 40%.

5. Subjects who have previously received CD19 targeted therapy must have biopsy-proven lymphoma lesions still express CD19 antigen.

Exclusion Criteria:

1. Lymphomas involving only the central nervous system (CNS) (subjects with secondary CNS lymphomas are admitted).

2. History of another malignancy that has not been in remission for at least 2 year (the following conditions may be excluded from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumor with low probability of recurrence, limited-stage prostate cancer after treatment, biopsy-proven cervical carcinoma in situ, or PAP smear showing squamous epithelium internal lesions).

3. History of treatment with Alemtuzumab within 6 months prior to leukapheresis, or Fludarabine or Cladribine within 3 months prior to leukapheresis.

4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.

5. Uncontrolled fungal, bacterial, viral, or other infection.

6. Acute or chronic graft-versus-host disease (GVHD).

7. History of any of the following cardiovascular diseases within the past 6 months:

Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stent, myocardial infarction, unstable angina, or other clinically significant heart disease.

8. History or clinical evidence of CNS disease.

9. Female subjects who are pregnant or lactating.

10. Prior CAR-T therapy or other genetically modified T cell therapy.