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Trial Title:
Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies
NCT ID:
NCT05528887
Condition:
Relapsed/Refractory Hematological Malignancies
Lymphoma
Myeloma
Leukemia
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Cyclophosphamide
Fludarabine
Conditions: Keywords:
CD19 CAR-T
BCMA CAR-T
CD7 CAR-T
CD123 CAR-T
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Autologous CAR-T cells
Description:
D0: CAR-T cells will be infused intravenously.
Arm group label:
Autologous CAR-T cells
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
D-5 to D-3: Fludarabine (30 mg/m^2/day) will be administered intravenously for 3 days.
Arm group label:
Autologous CAR-T cells
Other name:
Fludara
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
D-5 to D-3: Cyclophosphamide (500 mg/m^2/day) will be administered intravenously for 3
days.
Arm group label:
Autologous CAR-T cells
Other name:
Cytoxan
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated People's Hospital of Ningbo University
Address:
City:
Ningbo
Zip:
315101
Country:
China
Status:
Recruiting
Contact:
Last name:
Dong Chen
Phone:
+8613805888089
Email:
13805888089@163.com
Start date:
September 16, 2021
Completion date:
June 2026
Lead sponsor:
Agency:
The Affiliated People's Hospital of Ningbo University
Agency class:
Other
Collaborator:
Agency:
UTC Therapeutics Inc.
Agency class:
Industry
Source:
The Affiliated People's Hospital of Ningbo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05528887
