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.
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
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
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.
- Conditions
- NHL - Non-Hodgkin's Lymphoma
- 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 group | Role | What they receive |
|---|---|---|
| SCTB35 Plus SCTB41 | Experimental | Not described Receives: Drug: SCTB35 injection; Drug: SCTB41 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Measured: Up to approximately 3 years
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
Percentage of Participants Achieving CR
Percentage of participants who achieve a CR determined per Lugano criteria.
Measured: Up to approximately 3 years
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
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
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
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
Adverse Events
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Measured: Up to approximately 3 years
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
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.
- First posted14 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHL - Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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