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B-cell Non-Hodgkin's LymphomaPhase 1NCT06894693

A Phase I Clinical Trial of RS001 in Patients with Relapsed/Refractory B-Cell Malignancies

A Phase 1 study testing RS001 injection in people with B-cell Non-Hodgkin's Lymphoma and Acute Lymphoblastic Leukemia, run by Guangdong Ruishun Biotech Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is an open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic profile in the body after infusion of RS001 injection, and preliminary efficacy in subjects with CD19-positive relapsed/refractory B-cell malignancies (BCM). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
RS001 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
No sites listed yet
Study dates
1 Apr 2025to 1 Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign an ICF and expect to complete the subsequent follow-up.
  • Aged 18 to 75 years (including cut-offs), regardless of gender.
  • Meet one of the following B-cell malignancies:
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  • . B-cell non-Hodgkin's lymphoma diagnosed as CD19-positive by cytology or histopathology according to WHO 2022 criteria, including pathologically confirmed (1) diffuse large B-cell lymphoma, non-specific type (DLBCL, NOS); (2) follicular lymphoma histopathologically graded as grade 3b (FL3b); (3) follicular lymphoma with diffuse large B-cell transformation; (4) primary mediastinal large B-cell lymphoma (PMBCL); (5) high-grade B-cell lymphoma (HGBCL).
  • Relapsed/refractory B-cell non-Hodgkin lymphoma, defined as meeting one or more of the following criteria:
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  • Definition of relapse: Relapse after achieving remission (PR and CR) with second-line or higher therapy;
  • Definition of refractory: No response to second-line or more therapy: The best efficacy of last therapy is PD or SD (SD requires at least 2 cycles of treatment); Recurrence (must have biopsy-proven recurrence) or progression within 12 months of autologous stem cell transplantation (ASCT) . If salvage therapy, no response to last therapy (SD or PD).
  • Subjects must have received adequate treatment in the past, which should include the following treatments:
  • Anti-CD20 monoclonal antibody, unless the investigator determines that the tumor is CD20 negative;
  • Chemotherapy containing anthracycline drugs;
  • For subjects with transformed follicular lymphoma (tFL) who have been previously treated with follicular lymphoma (FL) chemotherapy and with transformation to DLBCL show refractory to chemotherapy.
  • ECOG performance status 0 to 1.
  • The presence of a measurable lesion that meets one of the following criteria:
  • The long axis of the lymph node lesion exceeds 15 mm in length (the short axis is measurable);
  • The long and short axes of the extralymph node lesion exceed 10 mm in length.
  • Relapsed/refractory B-cell acute lymphoblastic leukemia must meet the following requirements:
  • Relapsed: Recurrence within 12 months after the first remission;
  • Refractory: i. failure to remit after more than 6 weeks of induction therapy or failure to remit after two courses of induction therapy; ii. relapse after 2 or more CRs; iii. first relapse after chemotherapy and failure to remit after having received at least 1 salvage therapy; iv. relapse after autologous hematopoietic stem cell transplantation;
  • Prior to screening, leukemia cells expressing CD19 are detectable in bone marrow or peripheral blood.
  • Ph+ ALL patients who have failed treatment with at least 2 tyrosine kinase inhibitor (TKI) drugs (including at least 1 2nd generation TKI drug) or are intolerant of drug-related side effects such as allergy to components of the TKI class of drugs, blood abnormalities, liver or kidney impairment, severe cardiovascular toxicity, and other drug-related side effects that prevent them from continuing to be a user; If the patient has the T315I mutation, TKI salvage therapy is not required;
  • The proportion of primitive and naïve lymphocytes in bone marrow during the screening period ≥5%; 4. Laboratory results within 7 days prior to Lymphodepletion need to meet the following criteria:
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  • Coagulation function:
  • Activated partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN);
  • Prothrombin time (PT) ≤ 1.5 times ULN;
  • Liver function:
  • Glutathione aminotransferase (AST) ≤ 5 times the upper limit of normal (ULN);
  • Total bilirubin ≤ 1.5 times ULN, unless the subject has documented Gilbert syndrome;
  • Subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included.
  • Renal function: Serum creatinine ≤ 1.5 times ULN or a creatinine clearance ≥ 60 ml/min;
  • Complete blood count (No blood transfusion treatment received within 7 days prior to examination):
  • Haemoglobin ≥ 80 g/L;
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L;
  • A platelet count ≥ 50 x 10^9/L;
  • Cardiopulmonary function:
  • Left ventricular ejection fraction (LVEF) ≥ 45%;
  • Oxygen saturation ≥ 91%; 5. Female subjects with of childbearing potential should have a negative pregnancy test during the screening period. Any male and female subjects of childbearing potential must agree to use an effective contraception method for at least six months from the time that they sign the informed consent form until the end of the cell infusion. Female subjects without childbearing potential (meeting at least 1 of the following criteria) is described below:
  • Have undergone a hysterectomy or bilateral oophorectomy; b. Medically recognised ovarian failure; c. Medically recognised as post-menopausal (at least 12 consecutive months of menopause without pathological or physiological cause).

Who cannot join

  • Other malignancies within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, post-radical localized prostate cancer, post-radical ductal carcinoma in situ, and post-radical thyroid cancer;
  • Any unstable systemic disease: including but not limited to active infection (other than local infection), unstable angina, cerebrovascular accident or transient ischaemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (refractory hypertension is defined as blood pressure that has not reached standard after >1 month of reasonably tolerable treatment with ≥3 antihypertensive drugs (including diuretics) at adequate doses based on lifestyle improvement or blood pressure that is not effectively controlled with ≥4 antihypertensive drugs), severe cardiac arrhythmias requiring pharmacologic treatment, hepatic arrhythmias, liver diseases, kidney diseases or metabolic disorders;
  • Patients with B-cell non-Hodgkin's lymphoma with active central nervous system invasion.
  • Patients with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titres not within the normal reference range, positive hepatitis C virus (HCV) antibody and peripheral blood HCV RNA ,positive for human immunodeficiency virus (HIV), or positive for cytomegalovirus (CMV) DNA, or positive syphilis test.
  • Subjects who are receiving systemic steroids prior to screening and who are judged by the investigator to require long-term treatment with systemic steroids during the treatment period (except for inhaled or topical use).
  • Previous organ transplantation or preparation for organ transplantation (except for haematopoietic stem cell transplantation).
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  • Persons with acute/chronic Graft-vs-Host Disease (GvHD).
  • Patients have received a haematopoietic stem cell transplant within 2 months prior to screening.
  • Patients who have previously received any CD19-CAR-T/NK cell therapy, or received CAR-T/NK cell therapy targeting other antigens within the three months prior to screening.
  • Active neurological autoimmune or inflammatory diseases (e.g. Guillain-Barre Syndrome (GBS), Amyotrophic lateral sclerosis (ALS)).
  • Clinically significant active cerebrovascular diseases (such as cerebral edema, posterior reversible encephalopathy syndrome).
  • Patients with a life expectancy of less than 3 months.
  • Participants who have previously been involved in other interventional clinical studies and received active investigational drugs, with the last use of an unapproved new drug being less than 28 days prior to signing the informed consent for this trial, or the last use of an approved drug being less than five half-lives prior to cell infusion.
  • Received attenuated live vaccine within 6 weeks prior to lymphodepletion.
  • The subjects have contraindications or hypersensitivity reactions to fludarabine, cyclophosphamide, tocilizumab, investigational product and its ingredients.
  • Remaining within the washout period of other antitumor treatments prior to lymphodepletion.
  • Patients who, in the investigator's judgment and/or clinical criteria, have a contraindication to any of the study procedures or have other medical conditions that may place them at unacceptable risk.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

JunYuan Qi, MD, PHD contact

18622662361

qijy@ihcams.ac.cn

About this study

Official title: A Phase I Clinical Trial of RS001 in Patients with Relapsed/Refractory B-Cell Malignancies:

This study is an open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic profile in the body after infusion of RS001 injection, and preliminary efficacy in subjects with CD19-positive relapsed/refractory B-cell malignancies (BCM).

Read the detailed description

CD19-positive relapsed/refractory B-cell malignancies (including B-cell non-Hodgkin lymphoma, B-cell acute lymphoblastic leukemia).

Being tested
RS001 injection
Medical subject headings
Lymphoma, B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • RS001 injectionBiological

    CD19-CAR-mbIL15-DNT Cells.

Study groups in NCT06894693
Study groupRoleWhat they receive
RS001 injectionExperimentalThe trial is divided into two parts: Part A is a dose escalation trial with three dose groups (5×10^6 CAR+ cells/kg, 1×10^7 CAR+ cells/kg and 2×10^7 CAR+ cells/kg at day 0), with 7-18 patients planned to be enrolled. Part B is a dose-expansion trial in which 6~12 patients will receive RS001 infusions at RP2D dose levels.
Receives: Biological: RS001 injection

What is being measured

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

  1. Dose-Limiting Toxicity (DLT)

    To evaluate the safety, tolerability, and determine the recommended dosage of RS001 for BCM subjects.

    Measured: Up to 28 days

  2. Maximum Tolerated Dose (MTD)

    MTD is the highest dose for DLT in ≤1/6 subjects.

    Measured: Up to 28 days

  3. Incidence of abnormalities

    Incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs.

    Measured: Up to 28 days

Secondary outcomes (12)

  1. Pharmacokinetics (PK) indicator (Cmax)

    The peak concentration of CD19-CAR-mbIL15-DNT cells amplified in the peripheral blood (Cmax, detected by qPCR or Flow Cytometry).

    Measured: Up to 90 days

  2. Pharmacokinetics (PK) indicator (AUC)

    CD19-CAR-mbIL15-DNT cells blood concentrations will be measured at different time points to evaluate the area under the curve (AUC). (AUC, detected by qPCR or Flow Cytometry).

    Measured: Up to 90 days

  3. Pharmacokinetics (PK) indicator (Tmax)

    CD19-CAR-mbIL15-DNT cells blood concentrations will be measured at different time points to evaluate the peak plasma time (Tmax). Tmax is defined as the time to reach the highest concentration (Tmax, detected by qPCR or Flow Cytometry).

    Measured: Up to 90 days

  4. Pharmacokinetics (PK) indicator (T1/2)

    CD19-CAR-mbIL15-DNT cells blood concentrations will be measured at different time points to evaluate the elimination half-life in hours (T1/2). T1/2 is defined as the time point when the concentration of CD19-CAR-mbIL15-DNT reaches half of maximum in a patient's peripheral blood (T1/2, detected by qPCR or Flow Cytometry).

    Measured: Up to 90 days

  5. Overall Response Rate

    Objective response rates (ORR; complete response [CR] + partial response [PR]) in B-NHL subjects and composite complete remission rates (CRc; CR + CR with incomplete hematologic recovery [CRi]) in ALL subjects were assessed using Lugano 2014 criteria / LYRIC Criteria (2016) and National Comprehensive Cancer Network (NCCN) guidelines (v3.2025), respectively.

    Measured: Up to 2 years

  6. Disease Control Rate

    The percentage of PR, CR and SD patients in the total B-NHL patient population.

    Measured: Up to 2 years

  7. Duration of Response

    The time from the start of the first assessment of CR or PR to the first assessment as disease recurrence or progression or death in B-NHL subjects.

    The time from the first assessment of the tumor for CR or CRi to the first assessment of disease recurrence or death from any cause in B-ALL subjects.

    Measured: Up to 2 years

  8. Progression Free Survival

    The time from the first cell infusion to the first evaluation of tumor progression or death from any cause in B-NHL subjects.

    Measured: Up to 2 years

  9. Overall Survival

    From the date of entry into the clinical study until death from any cause

    Measured: Up to 2 years

  10. Overall Response Rate at 3 months

    The percentage of PR and CR patients in B-NHL patient population at 3 months.

    Measured: Up to 3 months

  11. Relapse-Free Survival

    Evaluate only ALL patients who achieved CR or CRi. This refers to the period from the first assessment of CR or CRi until the first evaluation indicating disease relapse or death from any cause during CR or CRi.

    Measured: Up to 2 years

  12. Event-Free Survival

    This is used for evaluating all ALL subjects. The period starts from the first infusion of RS001 injection until treatment failure, relapse, or death (any cause), whichever occurs first. For subjects without these events, the timeframe will be calculated up to the date of the last follow-up visit. For patients who did not achieve CR or CRi, EFS will be calculated from the clinical trial enrollment date until disease progression or death, with the first occurring event being considered as the endpoint.

    Measured: Up to 2 years

Timeline

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

  1. First posted25 Mar 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Apr 2028 (estimated)

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06894693
Sponsor's protocol ID
RS001-BCM001
Status last verified
Mar 2025
First submitted
18 Mar 2025
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RS001 injection in people with B-cell Non-Hodgkin's Lymphoma and Acute Lymphoblastic Leukemia, run by Guangdong Ruishun Biotech Co., Ltd.

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 39 inclusion and 17 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: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact JunYuan Qi, MD, PHD (18622662361, qijy@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: Up to 28 days). The study lists 3 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 NCT06894693.

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 25 Mar 2025.

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