Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

Last updated: September 1, 2022
Sponsor: The Affiliated People's Hospital of Ningbo University
Overall Status: Active - Recruiting

Phase

1

Condition

Blood Cancer

Carcinoma

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT05528887
2021-037
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histological diagnosis of hematological malignancies (such as lymphoma, myeloma,leukemia) refractory to, or relapsing after standard therapy.
  2. Positive expression of specific antigens.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
  4. Adequate organ functions:
  • Serum bilirubin ≤ 35 μmol/L;
  • Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2;
  • Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);
  • Brain natriuretic peptide (BNP)<80 pg/mL.
  1. Subjects must be able to understand the protocol and be willing to enroll the study,sign the informed consent, and be able to comply with the study and follow-upprocedures.

Exclusion

Exclusion Criteria:

  1. History of allergy to any of the drugs involved in the protocol.
  2. History of cardiac diseases:
  • Left ventricular ejection fraction (LVEF) < 50%;
  • Class III or IV heart failure as defined by the New York Heart Association (NYHA).
  1. History of another malignancy tumor.
  2. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), orsyphilis infection.
  3. Patients with any contraindications to allogeneic hematopoietic stem celltransplantation.
  4. Uncontrolled fungal, bacterial, viral, or other infection.
  5. Female subjects who are pregnant or lactating.

Study Design

Total Participants: 10
Study Start date:
September 16, 2021
Estimated Completion Date:
June 30, 2026

Study Description

CAR-T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety and efficacy of the CAR-T cells will be assessed.

Connect with a study center

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, Zhejiang 315101
    China

    Active - Recruiting

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