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NHL - Non-Hodgkin's LymphomaPhase 1/2NCT07819188

SCTB35 and SCTB41 With or Without Chemotherapy in Non-Hodgkin Lymphoma

A Phase 1/2 study testing SCTB35 injection and SCTB41 in people with NHL - Non-Hodgkin's Lymphoma, run by Sinocelltech Ltd. at 1 site 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
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Trial summary

The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of SCTB35 and SCTB41 With or Without Chemotherapy in non-Hodgkin's lymphoma patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
NHL - Non-Hodgkin's Lymphoma
What is being tested?
SCTB35 injection and SCTB41
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
30 Sep 2026to 30 Sep 2029
Phase
Phase 1/2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 80 years (inclusive) at the time of informed consent
  • Histologically or cytologically confirmed B cell neoplasm.
  • Phase 1: Relapsed or refractory disease after at least two prior systemic therapy.
  • Measurable or evaluable disease at enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate organ and bone marrow function
  • Life expectancy of ≥ 3 months

Who cannot join

  • Prior treatment with bispecific antibodies targeting both CD20 and CD3
  • Prior treatment with antibodies targeting both PD-1/PD-L1, PD-(L)1/VEGF(R) or PD-(L)1/TGF-β
  • Eligible for high dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT)
  • Known central nervous system (CNS) involvement by lymphoma
  • Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks
  • Chemotherapy and other non-investigational antineoplastic agents within 4 weeks or 5 half-lives (whichever is shorter) prior to first SCTB35 administration

Trial locations and contacts

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

China1 site

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjing, Tianjing, 301636

    Lugui Qiu, M.D., 022-23909172, qiulg@ihcams.ac.cn

Other trials in China

About this study

Official title: A Phase Ib/II Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of SCTB35 in Combination With SCTB41, With or Without Concomitant Chemotherapy, in Patients With Non-Hodgkin's Lymphoma.

The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of SCTB35 and SCTB41 With or Without Chemotherapy in non-Hodgkin's lymphoma patients.

Being tested
SCTB35 injection, SCTB41
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

    SCTB35 will be subcutaneously administered at a dose as specified

  • SCTB41Drug

    SCTB41 will be IV administered at a dose as specified

Study groups in NCT07819188
Study groupRoleWhat they receive
SCTB35 Plus SCTB41ExperimentalNot described
Receives: Drug: SCTB35 injection; Drug: SCTB41

What is being measured

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

  1. Phase 1: dose limited toxicity (DLT)

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

    Measured: Within 28 days of the first administration

  2. Phase 2: Percentage of Participants Achieving Objective Response Rate (ORR)

    ORR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria

    Measured: Up to approximately 3 years

Secondary outcomes (10)

  1. Overall Survival (OS)

    Overall survival is defined as the time from randomization to death from any cause.

    Measured: Up to approximately 3 years

  2. Progression free survival (PFS)

    Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.

    Measured: Up to approximately 3 years

  3. Percentage of Participants Achieving CR

    Percentage of participants who achieve a CR determined per Lugano criteria.

    Measured: Up to approximately 3 years

  4. Duration of Response (DOR)

    DOR is defined as the time from the first documented response (CR or PR) to disease progression or death, whichever occurs first.

    Measured: Up to approximately 3 years

  5. Duration of Complete Response (DOCR)

    DOCR is defined as the time from the first documented CR to disease progression or death, whichever occurs first.

    Measured: Up to approximately 3 years

  6. Time to Response (TTR)

    Time to response (TTR) is defined as the time from the start of therapy to the first documented CR or PR in patients who achieve an objective response

    Measured: Up to approximately 3 years

  7. Time to Complete Response (TTCR)

    TTCR is defined as the time from the start of therapy to the first documented CR among patients with a complete response.

    Measured: Up to approximately 3 years

  8. Adverse Events

    Treatment-emergent adverse events/serious adverse events/adverse events of special interest

    Measured: Up to approximately 3 years

  9. Blood Concentrations of SCTB35 and SCTB41

    Pharmacokinetics of SCTB35 and SCTB41 will be assessed using drug concentrations measured in plasma (or serum) at specified time points.

    Measured: Up to approximately 6 months

  10. Anti-drug Antibodies of SCTB35 and SCTB41

    Serum (or plasma) samples will be tested for the presence of anti-drug antibodies (ADAs) against SCTB35 and SCTB41

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted14 Sep 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2029 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07819188
Sponsor's protocol ID
SCTB35-SCTB41-X201
Status last verified
Aug 2026
First submitted
8 Sep 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SCTB35 injection and SCTB41 in people with NHL - Non-Hodgkin's Lymphoma, run by Sinocelltech Ltd. at 1 site 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 7 inclusion and 6 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 14 Sep 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 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 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: dose limited toxicity (DLT) (time frame: Within 28 days of the first administration). 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 NCT07819188.

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 14 Sep 2026.

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