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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528887
• Other study ID #: 2021-037
• Status: Recruiting
• Phase: Phase 1
• Start date: September 16, 2021
• Est. completion date: June 2026

Study information

• Verified date: September 2022
• Source: The Affiliated People's Hospital of Ningbo University
• Contact: Ying Lu
• Phone: 86-13486090834
• Email: 814871416[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Myeloma
• Neoplasms
• Relapsed/Refractory Hematological Malignancies

Intervention

Biological:
• Autologous CAR-T cells
D0: CAR-T cells will be infused intravenously.

Drug:
• Fludarabine
D-5 to D-3: Fludarabine (30 mg/m^2/day) will be administered intravenously for 3 days.
• Cyclophosphamide
D-5 to D-3: Cyclophosphamide (500 mg/m^2/day) will be administered intravenously for 3 days.

Locations

Country	Name	City	State
China	The Affiliated People's Hospital of Ningbo University	Ningbo	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated People's Hospital of Ningbo University	UTC Therapeutics Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEAEs	Incidence and severity of Treatment Emergent Adverse Event.	4 weeks
Primary	TRAEs	Incidence and severity of Treatment Related Adverse Events.	4 weeks
Primary	AESIs	Incidence and severity of AEs of Special Interest.	4 weeks
Secondary	Objective Response Rate (ORR) (PR+CR)	The proportion of patients with complete response(CR) or partial response(PR)	12 months
Secondary	Progression-Free Survival (PFS)	PFS was defined as the time from CAR-T infusion to the date of disease progression or death from any cause.; Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.	12 months
Secondary	Overall survival (OS)	OS was defined as the time from CAR-T infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date.	12 months