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Non-Hodgkin Lymphoma, B-cellPhase 1/2NCT06705530

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

A Phase 1/2 study testing Hem101 in people with Non-Hodgkin Lymphoma, B-cell and Acute Lymphoblastic Leukemia ALL, run by National Research Center for Hematology, Russia at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Hem101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteRussia
Study dates
26 Nov 2024to 17 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients with B-cell lymphoproliferative disorders:
  • 1a. 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,
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  • Second and subsequent relapses, including neurorelapse,
  • Refractory disease course after two or more lines of chemotherapy,
  • Relapsed or refractory disease after allo-HSCT with transplantation performed more than 100 days ago and more than 4 weeks after withdrawal of immunosuppressive therapy before inclusion.
  • 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.
  • 1c. 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.
  • 1d. In cases of indolent B-cell non-Hodgkin's lymphoma, disease status satisfies one of the following criteria:
  • early relapse (POD 24) in patients with contraindications to auto-HSCT,
  • absence of clinical and hematologic remission after 1 line of therapy in the presence of TR53 mutation,
  • relapse in the presence of signs of transformation into aggressive lymphoma,
  • resistance to the previously performed 2 or more lines of therapy. 2. Male or Female subjects aged 18-70 years (at the time of signing the informed consent form).
  • 3. CD19 antigen expression of ≥20% (for B-ALL) or presence of CD19 expressing tumor cell population (for lymphoma).
  • 4. ECOG 0-2 points. 5. Life expectancy of at least 12 weeks. 6. Absolute CD3+ lymphocyte count in peripheral blood greater than 0.110^9 cells/L.
  • 7. Preserved organ function, defined as:
  • Lung function: absence of hypoxemia according to pulse oximetry (SrO2 >91%) when breathing atmospheric air;
  • Renal function: creatinine <130 µmol/L or ICF >60 ml/min per 1.73m2;
  • Liver function: total bilirubin concentration less than 34 μmol/L, ALT concentration not exceeding more than 5 times the upper limit of reference values (except for Gilbert's syndrome);
  • Cardiac function: stable hemodynamics and ejection fraction not less than 45%, absence of ejection in the pericardial cavity.
  • 8. Male or female patients with a very low probability of conception characterized by meeting at least one of the following criteria:
  • Patient is not of reproductive potential. A female patient of no reproductive potential characterized by one of two criteria: (1) attainment of natural menopause (defined as 12 months of spontaneous amenorrhea in women >45 years of age or 6 months of spontaneous amenorrhea with a serum FSH concentration characteristic of the postmenopausal range as determined by the laboratory) or (2) bilateral ovariectomy and/or hysterectomy or bilateral fallopian tube ligation at least 6 weeks before screening.
  • The patient is of reproductive potential and agrees to abstain from sexual activity or to use (including partner use) an acceptable method of contraception for the planned duration of the study. Acceptable contraceptive methods are hormonal contraception, intrauterine contraceptive device (IUD), diaphragm with spermicide, contraceptive sponge, condom, and vasectomy (performed at least 6 weeks prior to screening).
  • 9. Consent for continued follow-up for 15 years from study inclusion. 10. Adequate central or peripheral vascular access for the apheresis procedure. 11. The patient understands the study procedures, available alternative therapies, and study risks and voluntarily agrees to participate by providing written informed consent.

Who cannot join

  • 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.
  • Uncontrolled life-threatening infection (positive blood culture within 72 h prior to CAR-T product transfusion). Urinary tract infection is allowed. Patients receiving intravenous antibiotics prior to transfusion or in whom intravenous antibiotics have not been discontinued 7 days before inclusion in the study are not included. Prophylactic use of antibiotics, antiviral, and antifungal agents is allowed.
  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • National Medical Research Center for Hematology

    Moscow, 125167

Other trials in Russia

About this study

Official title: An Interventional Open-label, Single-group, Phase I/II Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Adult Patients With Relapsed or Refractory Forms of B-cell Lymphoproliferative Disorders

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.

Read the detailed description

This Phase I/II open-label, single-arm clinical trial evaluates the safety, tolerability, and efficacy of anti-CD19 CAR-T cell therapy in adult patients with relapsed or refractory B-cell lymphoproliferative disorders, including B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (NHL). Anti-CD19 CAR-T therapy uses genetically modified T cells engineered to recognize and destroy cancer cells with the CD19 antigen. The investigational therapy utilizes second-generation CAR-T cells. The primary objective of the study is to assess the overall response rate (ORR) at Day 28. In contrast, secondary objectives include evaluating progression-free survival (PFS), duration of response (DoR), and overall survival (OS).

The trial will recruit 60 participants between 18 and 70 years old who meet specific eligibility criteria, including CD19 expression on tumor cells and adequate organ function. Participants will first undergo lymphodepletion to prepare their immune systems for CAR-T cell infusion. The CAR-T therapy will be administered in two doses via intravenous infusion. This dosing regimen is designed to optimize safety and maximize therapeutic benefit. The treatment period includes close inpatient monitoring for at least 14 days, followed by additional outpatient assessments.

Safety and tolerability are key components of the study, with close observation for potential side effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Other safety measures include evaluating organ function, monitoring for infections, and assessing the presence of antibodies against CAR-T cells. Efficacy will be determined based on tumor responses, measured as complete or partial remission, and by tracking the persistence and expansion of CAR-T cells in the blood.

This study is being conducted at a single clinical center in Russia and is sponsored by the National Medical Research Center of Hematology, Ministry of Health of Russia. The expected duration for each participant is approximately 53 days, with long-term follow-up planned to evaluate the durability of treatment responses and overall survival outcomes. The findings from this study will help determine whether anti-CD19 CAR-T therapy is a viable treatment option for patients with difficult-to-treat B-cell blood cancers.

Being tested
Hem101
Keywords
CAR-T, B-cell lymphoma, non-Hodgkin lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hem101Biological

    Also called Hemagenleukleucel

    CAR-T lymphocytes specific to CD19 B-cell antigen

Study groups in NCT06705530
Study groupRoleWhat they receive
Hem101 ArmExperimentalThe 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
Receives: Biological: Hem101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 28 days

  2. 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.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start26 Nov 2024
  3. Primary completion17 Oct 2025
  4. Study completion17 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705530
Sponsor's protocol ID
HemC101-01-01
Status last verified
Feb 2026
First submitted
22 Nov 2024
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Hem101 in people with Non-Hodgkin Lymphoma, B-cell and Acute Lymphoblastic Leukemia ALL, run by National Research Center for Hematology, Russia at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06705530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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