A Phase 1/2 interventional study of SCTB35 injection and SCTB41 in NHL - Non-Hodgkin's Lymphoma, sponsored by Sinocelltech Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Sinocelltech Ltd. (part of Sinocelltech Group Limited) · Phase 1/2, Interventional, and Treatment
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.
2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 287 are open to participants now.
This study's planned enrollment of 90 is above the median of 40 across 1,883 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Sinocelltech Ltd. is the lead sponsor of 82 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SCTB35 injection · Drug: SCTB41
SCTB35 will be subcutaneously administered at a dose as specified
SCTB41 will be IV administered at a dose as specified
Phase 1: dose limited toxicity (DLT)
To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part
Time frame: 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
Time frame: Up to approximately 3 years
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Time frame: 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.
Time frame: Up to approximately 3 years
Percentage of Participants Achieving CR
Percentage of participants who achieve a CR determined per Lugano criteria.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to approximately 3 years
Adverse Events
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Time frame: 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.
Time frame: 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
Time frame: Up to approximately 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 69 industry-sponsored phase 1/2 interventional studies under Lymphoma, Non-Hodgkin, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 103. This study's planned 24 months is below that.
Counting every sponsor, half of 135 studies reached it within 72 months; a quarter within 50 and three quarters within 106.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SCTB41