A Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Patients With B-cell Lymphoproliferative Disorders

NCT06705530 | Completed Phase 1

• 1 other identifier: HemC101-01-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing a new type of treatment called anti-CD19 CAR-T cell therapy for adults with certain blood cancers that have returned or did not respond to previous treatments. CAR-T cells are a type of immune cell that is specially designed in a lab to target and destroy cancer cells with a marker called CD19. The main goals of this study are to find out if this treatment is safe, how well patients tolerate it, and how effective it is at controlling cancer. The study will include 60 adults, ages 18-70, who meet specific criteria for participation. Patients will first receive a short course of chemotherapy to prepare their bodies for the CAR-T cells. The CAR-T cells will then be given in two doses through an IV. Patients will be monitored closely in the hospital for about a month to check for any side effects and see how their cancer responds. The researchers will also follow up with patients over time to learn more about how long the CAR-T cells stay active, how well they fight cancer, and the overall health of the patients after treatment.

Conditions

Acute Lymphoblastic Leukemia ALL; Non-Hodgkin Lymphoma, B-cell

Keywords

CAR-T; B-cell lymphoma; non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Frequency of any adverse events (AEs) reported during the study period and AE characterization (severity, seriousness, etc.) on day 28

  28 days

• Primary Efficacy Outcome: ORR

  Overall response rate (ORR) defined as the proportion of subjects with complete response (CR) or partial response (PR) on Day 28.

  28 days

Study Arms (1)

Hem101 Arm

EXPERIMENTAL

The investigational product (Hem101) will be administered as an intravenous infusion twice to each patient, on Day 1 and Day 2 of the dose if the first dose is well tolerated

Biological: Hem101

Interventions

Hem101 BIOLOGICAL

CAR-T lymphocytes specific to CD19 B-cell antigen

Also known as: Hemagenleukleucel

Hem101 Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with B-cell lymphoproliferative disorders:
• a. In cases of B-cell lymphoproliferative disorders developed from lymphocyte precursors (ALL/LBL), the disease status satisfies one of the following criteria:
• Failure of induction (primary-refractory course or MOB persistence), absence of clinical and hematologic remission after first-line therapy,
• MOB persistence with achieved second and subsequent clinical and morphologic remissions,
• Early medullary or combined relapse if the duration of the first remission is not more than 12 months, provided the disease is stabilized,
• Confirmed MOB relapse,
• Second and subsequent relapses, including neurorelapse,
• Refractory disease course after two or more lines of chemotherapy,
• b. In the case of Ph-positive ALL/LBL:
• Molecular relapse, advanced relapse, isolated neurorelapse, or refractory disease after the use of more than 2 lines of ITC.
• c. In cases of aggressive B-cell non-Hodgkin's lymphoma, disease status satisfies one of the following criteria:
• Absence of remission after 1-2 courses of intensive chemotherapy or in the presence of factors of unfavorable prognosis (TP53 mutation, co-expression of c-MYC and BCL2, abnormalities of c-MYC, BCL2, BCL6, and other genes),
• Disease progression on chemotherapy in the form of the appearance of a new lesion focus or increase of the initial focus by at least 50% during therapy,
• Relapse within 12-18 months after the end of chemotherapy, regardless of the presence or absence of factors of unfavorable prognosis,
• Resistance to 2 or more prior lines of therapy.

You may not qualify if:

• Tumor cell surface CD19 expression level \<20% for B-ALL by flow cytometry or no CD19 expression for lymphoma by immunohistochemical analysis.
• Acute/active hepatitis B, C, or acute HIV infection, COVID-19.
• CD3+ T-lymphocyte content in peripheral blood is less than 0.1\*10\^9 cells/L.
• Previous treatment with gene therapy products.
• Clinically significant CNS pathology (epilepsy, generalized convulsive disorder, paresis, aphasia, stroke, severe brain damage, dementia, Parkinson's disease, cerebellar disease, organic cerebral syndrome, psychosis) at present or in the anamnesis.
• NYHA class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or any other significant cardiac pathology within the previous 6 months.
• Associated genetic syndromes (such as Nijmegen syndrome, Kostman syndrome, Schwachman syndrome, or any other known bone marrow failure syndrome).
• Pregnancy, planning pregnancy during the study, or lactation period.
• Use of drugs or therapeutic interventions prohibited by the protocol (glucocorticosteroids, allogeneic cell therapy, GvHD therapy, chemotherapy, alemtuzumab, clofarabine, cladribine, mouse-derived biologics).
• Participation in a clinical trial taking any investigational drug within 30 days prior to screening with the exception of investigational antimicrobials (antibiotics, antimycotics, and antivirals).
• Any clinically relevant data that, in the opinion of the investigator, affects the patient's ability to enter the study and puts the patient at risk if they participate in the study.
• Uncontrolled medical, psychological, familial, sociological, or geographical conditions and conditions that, in the investigator's opinion, make it impossible to achieve acceptable adherence to the study protocol and the subjects' unwillingness or inability to follow the protocol procedures.

Sponsors & Collaborators

• National Research Center for Hematology, Russia: lead

Study Sites (1)

National Medical Research Center for Hematology

Moscow, 125167, Russia

Location

Related Links

• Offical approval of the trial by the Ministry of Health of the Russian Federation

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: November 26, 2024
• Primary Completion: October 17, 2025
• Study Completion: November 17, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)