The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies

Multiple Myeloma Clinical Trial

Official title:

The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618041
• Other study ID #: 20221019
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: December 6, 2024

Study information

• Verified date: November 2022
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Shengmin Guo
• Phone: 008618633039369
• Email: guoshengmin[@]senlangbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.

Description:

Main research purposes: To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies. Secondary research purposes: Objective Evaluation of Cytodynamic Characteristics of CAR-T in Different Types of Hematological Malignancies

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 6, 2024
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

• Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet;
• Diagnosed as recurrent or refractory lymphoma, leukemia or myeloma;
• Tumor cells express targets for CAR-T cell therapy (results: flow cytometry or Immunohistochemical test confirmation);
• Age 14-75 (including threshold), gender unlimited;
• Eastern Cooperative Oncology Group (ECOG) score =2;
• HGB = 70g/L (blood transfusion allowed);
• Liver and kidney functions, heart and lung functions meet the following requirements:

1. Creatinine = 1.5 × ULN;

2. Left ventricular ejection fraction = 50%;

3. Blood oxygen saturation>90%;

4. Total bilirubin = 1.5 × ULN; ALT and AST = 2.5 × ULN;

• For T cell tumor patients, if tumor cells are detected in peripheral blood during screening, flow cytometry should be used to detect that the tumor cell surface immunophenotype is CD4 and CD8 double negative. If the immunophenotype of peripheral blood tumor cells is not double negative for CD4 and CD8, the condition that the proportion of peripheral blood tumor cells is = 1% shall be met;
• Subjects with pregnancy plans must agree to use contraception before entering the study and after the study lasts for six months; If the subject is pregnant or suspected of being pregnant, the investigator shall be informed immediately;
• The subject or guardian understands and signs the informed consent form;
• Expected survival longer than 3 months.

Exclusion Criteria:

• Severe cardiac insufficiency;
• Have a history of severe lung impairment;
• Complicated with other advanced malignant tumors;
• Complicated with severe or persistent infection that cannot be effectively controlled;
• Complicated with severe autoimmune diseases or congenital immune deficiency;
• Active hepatitis (HBV DNA or HCV RNA positive);
• Human immunodeficiency virus (HIV) infection or syphilis infection;
• Have a history of severe allergy to biological products (including antibiotics);
• If there is a history of hematopoietic stem cell transplantation, it should be no more than 6 months before the patient receives allogeneic hematopoietic stem cell transplantation;
• Subjects who received CAR-T therapy or other gene modified cell therapy before screening;
• Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Hematologic Neoplasms
• Lymphoma
• Multiple Myeloma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• CAR-T Autologous T cell injection
Biological: CAR-T; Drug: Cyclophosphamide,Fludarabine;Procedure: Leukapheresis

Locations

Country	Name	City	State
China	Shanxi Bethune Hospital	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence and severity of adverse events	To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity	First 1 month post CAR-T cells infusion
Primary	Efficacy: Remission Rate	Complete remission (CR) Complete remission with incomplete recovery of blood cells (CRI), positive minimal residual tumor (MRD+) or negative tumor (MRD -) CR/CRI, disease recurrence or progression (PD) were evaluated, and the overall remission rate was ORR=CR+CRI; For drenching Complete remission (CR), partial remission (PR), disease stability (SD) Disease recurrence or progression (PD) was evaluated, and the overall remission rate was ORR=CR+PR; For multiple myeloma Complete remission (CR), partial remission (VGPR, PR), disease stability (SD), disease recurrence or progression (PD) were adopted, Overall remission rate ORR=CR+VGPR+PR;	3 months post CAR-T cells infusion
Secondary	progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion
Secondary	CAR-T proliferation	the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method	3 months post CAR-T cells infusion
Secondary	Cytokine release	Cytokine( IL-6,IL-10,IFN-?,TNF-a ) concentration (pg/mL) by flow cytometry method	1 month post CAR-T cells infusion