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

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

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Multiple Myeloma; Acute Lymphoblastic Leukemia
• Intervention / Treatment: Biological: CAR-T Autologous T cell injection

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weiwei w Tian, MD; Phone Number: 008613485304136; Email: tianweiwei@yeah.net
• Study Contact Backup: Name: Na Kuang, MD; Phone Number: 008618630160116; Email: kuangna@senlangbio.com

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Bethune Hospital
      • Contact: Weiwei Tian, MD; Phone Number: 008613485304136

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAR-T Autologous T cell injection; Patients will be treated with CAR-T cells	Biological: CAR-T Autologous T cell injection; Biological: CAR-T; Drug: Cyclophosphamide,Fludarabine；Procedure: Leukapheresis; Other Names: CD19 CAR-T; CD20 CAR-T; BCMA CAR-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion
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
Cytokine release	Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method	1 month post CAR-T cells infusion

Collaborators and Investigators

• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Collaborators: Hebei Taihe Chunyu Biotechnology Co., Ltd
• Investigators: Study Director: Weiwei w Tian, MD, Shanxi Bethune Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Estimated): September 6, 2027
• Study Completion (Estimated): December 6, 2027

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: CD19,CD20,BCMA; B-ALL/MM/NHL
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Lymphoid; Leukemia; Hematologic Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Multiple Myeloma
• Other Study ID Numbers: 20221019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No