CAR-T Technology for Recurrent/Refractory Malignant Hematological and Lymphatic Tumors

NCT06647329 | Not Yet Recruiting Phase 1

• 1 other identifier: hnslblCAR-T
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

evaluate the safety and Esfficacy of CAR-T technology for the treatment of recurrent/refractory malignant hematological lymphomas

Conditions

CAR-T Cell Therapy; Lymphomas

Keywords

CAR-T therapy; Recurrent/Refractory Malignant Hematological Lymphomas

Outcome Measures

Primary Outcomes (1)

• objective response rate(ORR)

  evaluate the efficacy of CAR-T cell infusion for the treatment of relapsed/refractory malignant hematological tumors

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

CAR-T therapy

Biological: CAR-T Therapy

Interventions

CAR-T Therapy BIOLOGICAL

CAR-T Technology for the Treatment of Recurrent/Refractory Malignant Hematological Lymphomas

Treatment

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:

• Participants must meet all of the following conditions to be included:
• The participant has given informed consent and signed the consent form, and is willing and capable of complying with the scheduled visits, study treatment, laboratory examinations, and other trial procedures.
• Clinically diagnosed as having relapsed/refractory malignant hematologic tumors:
• Diagnosed as CD19+ and/or CD20+ and/or CD22+ B-cell tumors through pathological and histological examinations, and the participant meets the criteria for relapsed or refractory B-cell malignancies as follows:
• B-cell tumors include the following three categories:
• A. B-cell acute lymphoblastic leukemia (B-ALL); B. Indolent B-cell lymphomas (CLL, FL, MZL, LPL, HCL); C. Aggressive B-cell lymphomas (DLBCL, BL, MCL).
• Refractory/relapsed B-cell leukemia (meeting one of the following four criteria): A. Relapse within 6 months after initial remission; B. Initial refractory after 2 cycles of standard chemotherapy without achieving complete remission; C. Relapse or refractory after first-line or multi-line salvage chemotherapy without achieving complete remission; D. Not suitable for hematopoietic stem cell transplantation, or have abandoned transplantation due to conditions, or relapse after transplantation.
• Refractory/relapsed B-cell lymphoma (meeting one of the first four criteria plus the fifth): A. Tumor shrinkage of less than 50% or disease progression after 4 cycles of standard chemotherapy; B. Achieved CR after standard chemotherapy, but relapsed within 6 months; C. Relapsed 2 times or more after achieving CR; D. Not suitable for hematopoietic stem cell transplantation, or have abandoned transplantation due to conditions, or relapse after transplantation;
• E. The participant must have received sufficient prior treatment, including at least:
• Anti-CD20 monoclonal antibodies
• Combination chemotherapy containing anthracyclines.
• Refractory/relapsed multiple myeloma: Progressed after at least 3 lines of treatment (at least one proteasome inhibitor and one immunomodulator used).
• Presence of measurable or evaluable lesions: A. For lymphoma patients, a single lesion ≥15 mm or two or more lesions ≥10 mm, or PET-positive lesions determined according to Lugano criteria; B. For leukemia and myeloma patients, bone marrow MRD must be persistently positive or positive relapse.
• Age 14-75 years (inclusive), both male and female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

You may not qualify if:

• History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) class III or IV heart failure, cardiovascular intervention (angioplasty or stenting), myocardial infarction, unstable angina, or other clinically significant heart diseases.
• History of severe pulmonary dysfunction.
• Concurrent advanced malignant tumors.
• Concurrent systemic fungal, bacterial, viral, or other infections that cannot be effectively controlled.
• Concurrent severe autoimmune diseases or congenital immunodeficiency.
• Active hepatitis (positive HBV DNA or HCV RNA testing).
• Human Immunodeficiency Virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
• History of severe allergic reactions to biologics (including antibiotics).
• Less than 6 months since undergoing allogeneic hematopoietic stem cell transplantation.
• Acute or chronic graft-versus-host disease (GvHD).
• History of deep vein thrombosis (DVT) (cancer-related thrombosis) or pulmonary embolism (PE) within 3 months prior to signing the informed consent form.
• Anticoagulation treatment for DVT or PE within 3 months prior to signing the informed consent form.
• History or clinical significance of CNS diseases at screening, such as epilepsy, seizure disorders, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or mental disorders.
• Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the start of lymphocyte-depleting chemotherapy.
• Use of any of the following medications or treatments within the specified time before leukapheresis:

Sponsors & Collaborators

• Mingzhi Zhang: lead

Study Sites (1)

the First Hospital of Zhengzhou University

Zhengzhou, Henan, 470000, China

Location

MeSH Terms

Conditions

Lymphoma; Recurrence

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Zhang Mingzhi Zhang PhD

CONTACT

86 13838565629; mingzhi_zhang1@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: the director of oncology department of the first affiliated hospital Investigator Affiliation

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 17, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

CN (1)