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

NCT05618041 | Recruiting

• 1 other identifier: 20221019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Lymphoblastic Leukemia; Lymphoma; Multiple Myeloma

Keywords

CD19,CD20,BCMA; B-ALL/MM/NHL

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• progression-free survival (PFS)

  24 months post CAR-T cells infusion

• CAR-T proliferation

  3 months post CAR-T cells infusion

• Cytokine release

  1 month post CAR-T cells infusion

Study Arms (1)

CAR-T Autologous T cell injection

EXPERIMENTAL

Patients will be treated with CAR-T cells

Biological: CAR-T Autologous T cell injection

Interventions

CAR-T Autologous T cell injection BIOLOGICAL

Biological: CAR-T; Drug: Cyclophosphamide,Fludarabine；Procedure: Leukapheresis

Also known as: CD19 CAR-T, CD20 CAR-T, BCMA CAR-T

CAR-T Autologous T cell injection

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Creatinine ≤ 1.5 × ULN;
• Left ventricular ejection fraction ≥ 50%;
• Blood oxygen saturation\>90%;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead
• Hebei Taihe Chunyu Biotechnology Co., Ltd: collaborator

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

RECRUITING

Related Publications (1)

• He S, Peng J, Yang X, Meng F, Huang L, Huang L, Tian W, Gao Z, Zhao J, Wang Z, Wei J. Peripheral Blood Smears Distinguish Infective Fever after CAR-T Therapy. Front Biosci (Landmark Ed). 2023 Nov 24;28(11):299. doi: 10.31083/j.fbl2811299.

  PMID: 38062808 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Weiwei w Tian, MD

  Shanxi Bethune Hospital

  STUDY DIRECTOR

Central Study Contacts

Weiwei w Tian, MD

CONTACT

008613485304136; tianweiwei@yeah.net

Na Kuang, MD

CONTACT

008618630160116; kuangna@senlangbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: September 7, 2022
• Primary Completion (Estimated): September 6, 2027
• Study Completion (Estimated): December 6, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)