CAR-T cell therapy for treating blood cancers that have returned or are resistant to treatment

Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies

This study is testing a new CAR-T cell therapy to see if it can help people with blood cancers that have come back or don’t respond to other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated People's Hospital of Ningbo University (other gov)
• Drugs / interventions: CAR-T, chemotherapy, cyclophosphamide, fludarabine
• Locations: 1 site (Ningbo, Zhejiang)
• Trial ID: NCT05528887 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of novel autologous CAR-T cells targeting various antigens, including CD19, CD123, BCMA, and CD7, in patients with relapsed or refractory hematological malignancies such as lymphoma, myeloma, and leukemia. Participants will undergo a conditioning chemotherapy regimen with fludarabine and cyclophosphamide before receiving the CAR-T cell treatment. The study aims to assess how well these engineered cells can enhance the immune response against tumors and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with hematological malignancies that have not responded to standard therapies and express specific target antigens.

Not a fit: Patients with a history of severe cardiac diseases or allergies to the drugs used in the study may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat blood cancers.

How similar studies have performed: Previous studies have shown promising results with CAR-T cell therapies targeting CD19 and other antigens, indicating a potential for success with this novel approach.

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.

Where this trial is running

Ningbo, Zhejiang

• The Affiliated People's Hospital of Ningbo University — Ningbo, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Ying Lu — The Affiliated People's Hospital of Ningbo University
• Study coordinator: Ying Lu

Conditions: Relapsed/Refractory Hematological Malignancies, Lymphoma, Myeloma, Leukemia, CD19 CAR-T, BCMA CAR-T, CD7 CAR-T, CD123 CAR-T