B-cell Non-Hodgkin's LymphomaPhase 1/2NCT06104553
A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma
A Phase 1/2 study testing SHR-A1912; R-Chemo in people with B-cell Non-Hodgkin's Lymphoma, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- SHR-A1912; R-Chemo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2023to Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Age greater than or equal to18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
- Life expectancy >3 months;
- Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma;
- Previous systematic anti-tumor therapy should meet the following requirements: 1) Relapsed and/or refractory disease after at least one (≥ 1) line of prior systemic therapy (relapsed/refractory cohort); 2) Previously untreated (naïve cohort).
- At least one measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as > 1.0 cm in its longest diameter.
Who cannot join
- Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment;
- History of recent major surgery or severe trauma within 4 weeks before the first study treatment;
- Received anti-tumour treatment within 2 weeks before the first study treatment;
- Central nervous system (CNS) infiltration;
- Active infection with HBV or HCV;
- History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis;
- Active infection or unexplained fever>38.5℃;
- History of severe cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, Doctor, +86-13683398726, songyuqin622@163.com
About this study
Official title: A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma
This study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma.
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Being tested
- SHR-A1912; R-Chemo
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1912; R-ChemoDrug
SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b)
SHR-A1912; R-ChemoDrug
SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2)
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1912 combined with R-Chemo (Phase 1b) | Experimental | Not described Receives: Drug: SHR-A1912; R-Chemo |
| SHR-A1912 combined with R-Chemo (Phase 2) | Experimental | Not described Receives: Drug: SHR-A1912; R-Chemo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy
Measured: The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months
Phase 1b: Incidence and severity of AE
Measured: Up to follow-up period, approximately 24 months]
Phase 2: Objective response rate
Measured: assessed up to approximately 24 months
Secondary outcomes (16)
Phase 1b: Objective response rate
Measured: assessed up to approximately 24 months
Phase 1b: Complete response rate (CRR)
Measured: assessed up to approximately 24 months
Phase 1b: Duration of remission (DoR)
Measured: assessed up to approximately 24 months
Phase 1b: Progression-free survival (PFS)
Measured: assessed up to approximately 24 months
Phase 1b: Toxin binding antibody to SHR-A1912
Measured: Up to follow-up period, approximately 24 months
Phase 1b: Total antibody to SHR-A1912
Measured: Up to follow-up period, approximately 24 months
Phase 1b: Concentration of free toxin
Measured: Up to follow-up period, approximately 24 months
Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912
Measured: Up to follow-up period, approximately 24 months
Phase 2: Complete response rate (CRR)
Measured: assessed up to approximately 24 months
Phase 2: Duration of remission (DoR)
Measured: assessed up to approximately 24 months
Phase 2: Progression-free survival (PFS)
Measured: assessed up to approximately 24 months
Phase 2: Incidence and severity of AE
Measured: Up to follow-up period, approximately 24 months
Phase 2: Toxin binding antibody to SHR-A1912
Measured: Up to follow-up period, approximately 24 months
Phase 2: Total antibody to SHR-A1912
Measured: Up to follow-up period, approximately 24 months
Phase 2: Concentration of free toxin
Measured: Up to follow-up period, approximately 24 months
Phase 2: Anti-drug antibodies (ADA) to SHR-A1912
Measured: Up to follow-up period, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start17 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An open, multicenter, dose-finding and dose expansion investigational Phase Ib/II clinical trial
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104553
- Sponsor's protocol ID
- SHR-A1912-II-201
- Status last verified
- Dec 2023
- First submitted
- 23 Oct 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma
- ClinicalTrials.gov ID
- NCT06104553
- Acronym / sponsor ID
- SHR-A1912-II-201
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open, multicenter, dose-finding and dose expansion investigational Phase Ib/II clinical trial
| Arm | Type | Receives |
|---|---|---|
| SHR-A1912 combined with R-Chemo (Phase 1b) | Experimental | Drug: SHR-A1912; R-Chemo |
| SHR-A1912 combined with R-Chemo (Phase 2) | Experimental | Drug: SHR-A1912; R-Chemo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
- Life expectancy >3 months;
- Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma;
- Previous systematic anti-tumor therapy should meet the following requirements: 1) Relapsed and/or refractory disease after at least one (≥ 1) line of prior systemic therapy (relapsed/refractory cohort); 2) Previously untreated (naïve cohort).
Key exclusion criteria (8 listed)
- Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment;
- History of recent major surgery or severe trauma within 4 weeks before the first study treatment;
- Received anti-tumour treatment within 2 weeks before the first study treatment;
- Central nervous system (CNS) infiltration;
- Active infection with HBV or HCV;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1912; R-ChemoSHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b) | Drug | SHR-A1912 combined with R-Chemo (Phase 1b) |
| SHR-A1912; R-ChemoSHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2) | Drug | SHR-A1912 combined with R-Chemo (Phase 2) |
Primary outcome
Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy
Time frame: The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months
Phase 1b: Incidence and severity of AE
Time frame: Up to follow-up period, approximately 24 months]
Phase 2: Objective response rate
Time frame: assessed up to approximately 24 months
16 secondary outcomes
Phase 1b: Objective response rate
Time frame: assessed up to approximately 24 months
Phase 1b: Complete response rate (CRR)
Time frame: assessed up to approximately 24 months
Phase 1b: Duration of remission (DoR)
Time frame: assessed up to approximately 24 months
Phase 1b: Progression-free survival (PFS)
Time frame: assessed up to approximately 24 months
Phase 1b: Toxin binding antibody to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Phase 1b: Total antibody to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Phase 1b: Concentration of free toxin
Time frame: Up to follow-up period, approximately 24 months
Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Phase 2: Complete response rate (CRR)
Time frame: assessed up to approximately 24 months
Phase 2: Duration of remission (DoR)
Time frame: assessed up to approximately 24 months
Phase 2: Progression-free survival (PFS)
Time frame: assessed up to approximately 24 months
Phase 2: Incidence and severity of AE
Time frame: Up to follow-up period, approximately 24 months
Phase 2: Toxin binding antibody to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Phase 2: Total antibody to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Phase 2: Concentration of free toxin
Time frame: Up to follow-up period, approximately 24 months
Phase 2: Anti-drug antibodies (ADA) to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-A1912; R-Chemo in people with B-cell Non-Hodgkin's Lymphoma, run by Shanghai Hengrui Pharmaceutical Co., 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Xiao, Medical Director (021-61053363, zhenyu.xiao.zx7@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy (time frame: The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months). 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?
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 27 Dec 2023.