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Non-Hodgkin Lymphoma, B-cellPhase 1NCT06318884

A First-in-human Study of SCTB35 in Patients With Relapse/Refractory B-cell Non-Hodgkin Lymphoma

A Phase 1 study testing SCTB35 injection in people with Non-Hodgkin Lymphoma, B-cell, run by Sinocelltech Ltd. at 3 sites in China.

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 is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma, B-cell
What is being tested?
SCTB35 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
3 sitesChina
Study dates
Apr 2024to Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible to be included in the study only if all the following conditions are met:
  • Age ≥ 18 years
  • Histologically or cytologically confirmed CD20+ mature B-cell neoplasm
  • For dose-escalation phase:
  • De novo or transformed diffuse large B-cell lymphoma (DLBCL)
  • High-grade B-cell lymphoma (HGBCL)
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  • Primary mediastinal large B-cell lymphoma (PMBCL)
  • Follicular lymphoma (FL)
  • Mantle cell lymphoma
  • Small lymphocytic lymphoma (SLL)
  • Marginal zone lymphoma (MZL) (nodal, extranodal or mucosa associated)
  • For dose expansion phase:
  • FL cohort: histologic confirmed FL grade 1, 2, or 3a at initial diagnosis without clinical or pathological evidence of transformation
  • LBCL cohort: including histologic confirmed DLBCL, not otherwise specified (NOS), Epstein-Barr virus+ DLBCL, transformed DLBCL from indolent subtypes, HGBCL, NOS, double/triple-hit HGBCL, FL grade 3b, and PMBCL
  • For dose-escalation phase:
  • Relapsed, progressive and/or refractory disease after adequate systemic therapy containing at least an anti-CD20 monoclonal antibody (e.g. rituximab)
  • Patients must have exhausted or are ineligible for all standard therapeutic options
  • Patients with indolent lymphoma (FL, MZL or SLL) must have a need for treatment initiation based on symptoms and/or disease burden
  • For dose-expansion phase:
  • Relapsed, progressive and/or refractory disease following ≥ 2 prior lines of adequate systemic therapy containing at least an anti-CD20 monoclonal antibody (e.g. rituximab)
  • At least 1 measurable site of disease based on computed tomography (CT) or magnetic resonance imaging (MRI) (defined as a clearly nodal lesion with the long axis > 1.5 cm or extranodal lesion with the long axis > 1.0 cm). Lesions that have previously received radiotherapy can be considered measurable only after confirming the presence of progression or residual lesions. (for the dose-escalation phase: a evaluable site of disease is allowed).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Adequate hepatic/hematologic/renal/cardiac functions indicated by laboratory values
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L within 7 days before first dose of study drug (without growth factor support). There is an exception for patients with bone marrow involvement in which case ANC must be ≥ 0.75 x 10^9/L
  • Platelets > 75 x 10^9/L within 7 days before first dose of study drug (without growth factor support or transfusion). There is an exception for patients with bone marrow involvement in which case platelets must be ≥ 50 x 10^9/L
  • Hemoglobin > 90 g/L within 7 days before first dose of study drug (independent of growth factor support or transfusion).
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 45 mL/min as estimated by Cockcroft-Gault equation
  • Adequate liver function indicated by: i) Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase ≤ 3 x ULN; ii) Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase ≤ 3 x ULN; iii) Total bilirubin level ≤ 1.5 x ULN (unless documented Gilbert's syndrome).
  • Left ventricular ejection fraction ≥ 50%;
  • Expected survival time is more than 3 months

Who cannot join

  • A patient who conforms to any of the following criteria should be excluded from the study:
  • Any prior therapy with an bispecific antibody of the same class
  • Eligible for high dose chemotherapy with hematopoietic stem cell transplantation (HSCT)
  • Known central nervous system (CNS) involvement by lymphoma
  • Known past or current malignancy other than inclusion diagnosis, with the following exceptions:
  • Cervical carcinoma of Stage Ib or less
Show all 30Show fewer
  • Non-invasive basal cell or squamous cell skin carcinoma
  • Non-invasive, superficial bladder cancer
  • Prostate cancer with a current prostate-specific antigen (PSA) level <0.1 ng/mL
  • Any curable cancer with a complete response (CR) of >2 years duration
  • Known clinically significant cardiac disease, including:
  • Onset of unstable angina pectoris or acute myocardial infarction within 6 months prior to signing Informed Consent Form (ICF)
  • Congestive heart failure prior to signing ICF (meets the criteria of New York Heart Association Classification III or IV)
  • Clinically significant arrhythmia prior to signing ICF
  • History of interstitial lung disease or uncontrolled lung diseases, or evidence of dyspnea at rest or pulse oximetry < 93% while breathing room air.
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy (including >20mg/day prednisolone [or equivalent], but low-dose prednisolone is allowed). The well controlled autoimmune disease can be enrolled at investigator's discretion, including:
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone
  • Patients with a history of type 1 diabetes mellitus who were well controlled (defined as a screening hemoglobin A1c < 8% and no urinary ketoacidosis)
  • Patients with skin disease who were not treated with systemic corticosteroid
  • History of seizure disorder or confirmed progressive multifocal leukoencephalopathy (PML)
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks prior to signing ICF
  • Positive for human immunodeficiency virus (HIV) antibody. Positive for hepatitis B antibody (except for only the positive HBsAb) with detectable hepatitis B virus (HBV) DNA. Positive for hepatitis C antibody with detectable hepatitis C virus (HCV) RNA
  • Chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to first SCTB35 administration (only applicable for dose-expansion phase)
  • Autologous HSCT within 100 days prior to first SCTB35 administration, or any prior allogeneic HSCT or solid organ transplantation
  • Received major surgery within 4 weeks prior to first SCTB35 administration, or planned to receive major surgery during the study
  • Received any chemotherapeutic agent, other anti-cancer agent, or investigational drug (monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first SCTB35 administration
  • Exposed to live or live attenuated vaccine within 4 weeks prior to first SCTB35 administration, or planned to receive these vaccines during the study
  • Pregnancy or breast feeding. During the study and for 6 months after last administration of SCTB35, a woman of childbearing potential or a man who is sexually active with a woman of childbearing potential disagrees to practice a highly effective method of birth control.
  • Patient has any condition for that, in the opinion of the investigator, participation could prevent, limit, or confound the protocol-specified assessments

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Junfan Ma, Ph.D contact

86-010-58628288

junfan_ma@sinocelltech.com

China3 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Yuqin Song, M.D., 010-88196118, SongYQ_VIP@163.com

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Lanfang Li, M.D., 18622221613, lilanfangmeng@163.com

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Keshu Zhou, M.D., 13674902391, dr_zkshu23810@163.com

Other trials in China

About this study

Official title: A Phase Ia/Ib Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SCTB35 in Patients With CD20+ Relapse/Refractory B-cell Non-Hodgkin Lymphoma

This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma.

Read the detailed description

This is the first-in-human study of SCTB35, containing the dose-escalation and dose-expansion parts. The escalation cohorts will be enrolled to explore the maximum tolerated dose and recommended phase II dose (RP2D). A Safety Monitoring Committee (SMC) will review the accumulated safety data and other available data, and make a recommendation to each dose level of SCTB35 in the escalation cohorts. The expansion cohorts will be initiated after the RP2D is confirmed, and to further compare the preliminary efficacy and safety of SCTB35 at two dose levels that appropriately recommended by SMC.

Being tested
SCTB35 injection
Keywords
Non-Hodgkin Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • SCTB35 injectionDrug

    Also called none other names

    SCTB35 will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and another appropriate dose of SCTB35 will be applied for the dose-expansion cohorts.

Study groups in NCT06318884
Study groupRoleWhat they receive
SCTB35ExperimentalSCTB35 injection is subcutaneously given every week for the first 4 cycles, and thereafter every 3 weeks. Cycles will be repeated every 3 weeks until disease progression, study discontinuation, or death, whichever occurs first.
Receives: Drug: SCTB35 injection

What is being measured

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

  1. Dose-escalation part: dose limited toxicity (DLT)

    To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part

    Measured: During the first cycle (21 days)

  2. Dose-escalation part: incidence rate of adverse event (AE)

    To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE), adverse event with special interest (AESI)

    Measured: From first dose until 28 days after last dose of study drug or until study completion or participant withdrawal (up to 3 years)

  3. Dose-expansion part: objective response rate (ORR)

    ORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR) as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

Secondary outcomes (18)

  1. Dose-escalation part: ORR

    ORR is defined as the percentage of patients achieving CR or PR as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  2. Dose-escalation part: CR rate (CRR)

    CR rate is defined as the percentage of patients with CR as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  3. Dose-escalation part: best of overall response (BOR)

    BOR is defined as the percentage of patients achieving best response from the first dose to first documented disease progression (PD) or new anticancer therapy, whichever occurs first, as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  4. Dose-escalation part: duration of response (DOR)

    DOR is defined as the time from first documented objective response to PD or death due to any cause, whichever occurs first, as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  5. Dose-escalation part: progression-free survival (PFS)

    PFS is defined as the time from first dose to first documented PD or death due to any cause, whichever occurs first, as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  6. Dose-escalation part: time to response (TTR)

    TTR is defined as the time from first dose to first documented objective response observed for patients who achieved a CR or PR, as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  7. Dose-escalation part: overall survival (OS)

    OS is defined as the time from first dose to death due to any cause

    Measured: From first dose until up to 5 years

  8. Dose-escalation part: blood concentrations of SCTB35

    The pharmacokinetics of SCTB35 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)

    Measured: From first dose until up to 2 years

  9. Dose-escalation part: anti-drug antibodies of SCTB35

    Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35

    Measured: From first dose until up to 2 years

  10. Dose-expansion part: CRR

    CR rate is defined as the percentage of patients with CR as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  11. Dose-expansion part: BOR

    BOR is defined as the percentage of patients achieving best response from the first dose to first documented PD or new anticancer therapy, whichever occurs first, as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  12. Dose-expansion part: DOR

    DOR is defined as the time from first documented objective response to PD or death due to any cause, whichever occurs first, as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  13. Dose-expansion part: PFS

    PFS is defined as the time from first dose to first documented PD or death due to any cause, whichever occurs first, as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  14. Dose-expansion part: TTR

    TTR is defined as the time from first dose to first documented objective response observed for patients who achieved a CR or PR, as determined by the investigator according to the Lugano Criteria 2014

    Measured: From first dose until up to 2 years

  15. Dose-expansion part: OS

    OS is defined as the time from first dose to death due to any cause

    Measured: From first dose until up to 5 years

  16. Dose-expansion part: AE

    To evaluate the incidence rates of TEAE, TRAE, SAE, AESI

    Measured: From first dose until up to 2 years

  17. Dose-expansion part: blood concentrations of SCTB35

    The pharmacokinetics of SCTB35 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)

    Measured: From first dose until up to 2 years

  18. Dose-expansion part: anti-drug antibodies of SCTB35

    Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35

    Measured: From first dose until 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 posted19 Mar 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2027 (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
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06318884
Sponsor's protocol ID
SCTB35-X101
Status last verified
Mar 2024
First submitted
12 Mar 2024
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCTB35 injection in people with Non-Hodgkin Lymphoma, B-cell, run by Sinocelltech Ltd. at 3 sites in China.

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 30 inclusion and 30 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 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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 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 Junfan Ma, Ph.D (86-010-58628288, junfan_ma@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-escalation part: dose limited toxicity (DLT) (time frame: During the first cycle (21 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 NCT06318884.

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 22 Mar 2024.

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