Clinical trial NCT05528887: Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies
Official title: Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed/Refractory Hematological Malignancies
Lymphoma
Myeloma
Leukemia
Keywords: CD19 CAR-T
BCMA CAR-T
CD7 CAR-T
CD123 CAR-T
Lead sponsor: The Affiliated People's Hospital of Ningbo University
Sponsor class: OTHER_GOV
Collaborators: name: UTC Therapeutics Inc.
First posted: 2022-09-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.
5. 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-up procedures.

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).
3. History of another malignancy tumor.
4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.
6. Uncontrolled fungal, bacterial, viral, or other infection.
7. Female subjects who are pregnant or lactating.

Primary outcomes:
measure: TEAEs
timeFrame: 4 weeks
measure: TRAEs
timeFrame: 4 weeks
measure: AESIs
timeFrame: 4 weeks
Secondary outcomes:
measure: Objective Response Rate (ORR) (PR+CR)
timeFrame: 12 months
measure: Progression-Free Survival (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
state: Zhejiang
Study officials:
affiliation: The Affiliated People's Hospital of Ningbo University
name: Ying Lu
role: PRINCIPAL_INVESTIGATOR
References: