B-ALLPhase 2NCT07244406
Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL
A Phase 2 study testing S1904 CD19 CAR-T in people with B-ALL, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL. Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- B-ALL
- What is being tested?
- S1904 CD19 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2025to 31 Dec 2028
- Phase
- Phase 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 3 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1.Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2.Male or female subjects. Age between 3 and 25 years (inclusive) at the time of ICF signing； 3.Confirmed diagnosis of relapsed/refractory B-ALL at ICF signing; 4.>5% blasts on screening bone marrow biopsy/aspirate; 5.CD19+ malignant cells by flow cytometry (bone marrow or peripheral blood) at screening; 6.Patients with Ph+ ALL are eligible if they meet the relapsed/refractory criteria and have either: failed ≥2 TKI regimens (unless they have a T315I mutation), demonstrated TKI intolerance, or have a contraindication to TKIs; 7.Estimated survival time>3 months.
Who cannot join
- 1.Relapse of isolated extramedullary disease; 2.Burkitt lymphoma/leukemia； 3.Active acute or moderate-to-severe chronic GVHD within 4 weeks prior to ICF signing. Or, any systemic GVHD treatment within 4 weeks prior to infusion; 4.No uncontrolled active infection at the time of ICF signing or apheresis.; 5.Prior receipt of any CAR-T therapy or other cellular/gene therapy before screening; 6.Received investigational drugs or systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever longer) prior to apheresis; 7.Active interstitial lung disease/pneumonitis at the time of ICF signing; 8.Subjects whom the Investigator considers unable to comply with the study protocol or who are otherwise not an appropriate candidate for the study for any reason;
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, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Xiaojun Huang
About this study
Official title: A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Senl_B19 Autologous Anti-CD19 CAR-T Cells in Subjects With Relapsed or Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia
To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.
Read the detailed description
The primary objective： To evaluate the efficacy of S1904 in pediatric and adult subjects with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.
The secondary objectives： To further characterize the efficacy and safety profiles of S1904 in this patient population.
- Conditions
- B-ALL
- Being tested
- S1904 CD19 CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1904 CD19 CAR-TBiological
Autologous CD19-targeting CAR T cells
| Study group | Role | What they receive |
|---|---|---|
| S1904 CD19 CAR-T | Experimental | Autologous CD19-targeting CAR T cells, dosage 1*10^6/kg, intravenous injection once Receives: Biological: S1904 CD19 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate after S1904 infusion [Effectiveness]
Independent Review Committee (IRC)-assessed ORR (CR + CRi) at Month 3 post-infusion, as per ALL Response Criteria.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start10 Jan 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-ALLStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojun Huang, Principal investigator, Peking University People's HospitalHongsheng Zhou, Principal investigator, Nanfang Hospital, Southern Medical UniversityRuidong Zhang, Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244406
- Sponsor's protocol ID
- S1904-201
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Senl_B19 Autologous Anti-CD19 CAR-T Cells in Subjects With Relapsed or Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07244406
- Acronym / sponsor ID
- S1904-201
- Conditions
- B-ALL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Nov 2025 (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.
To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.
Detailed description
The primary objective： To evaluate the efficacy of S1904 in pediatric and adult subjects with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.
The secondary objectives： To further characterize the efficacy and safety profiles of S1904 in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S1904 CD19 CAR-T | Experimental | Biological: S1904 CD19 CAR-TAutologous CD19-targeting CAR T cells, dosage 1*10^6/kg, intravenous injection once |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1.Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2.Male or female subjects. Age between 3 and 25 years (inclusive) at the time of ICF signing； 3.Confirmed diagnosis of relapsed/refractory B-ALL at ICF signing; 4.>5% blasts on screening bone marrow biopsy/aspirate; 5.CD19+ malignant cells by flow cytometry (bone marrow or peripheral blood) at screening; 6.Patients with Ph+ ALL are eligible if they meet the relapsed/refractory criteria and have either: failed ≥2 TKI regimens (unless they have a T315I mutation), demonstrated TKI intolerance, or have a contraindication to TKIs; 7.Estimated survival time>3 months.
Key exclusion criteria (1 listed)
- 1.Relapse of isolated extramedullary disease; 2.Burkitt lymphoma/leukemia； 3.Active acute or moderate-to-severe chronic GVHD within 4 weeks prior to ICF signing. Or, any systemic GVHD treatment within 4 weeks prior to infusion; 4.No uncontrolled active infection at the time of ICF signing or apheresis.; 5.Prior receipt of any CAR-T therapy or other cellular/gene therapy before screening; 6.Received investigational drugs or systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever longer) prior to apheresis; 7.Active interstitial lung disease/pneumonitis at the time of ICF signing; 8.Subjects whom the Investigator considers unable to comply with the study protocol or who are otherwise not an appropriate candidate for the study for any reason;
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 |
|---|---|---|
| S1904 CD19 CAR-TAutologous CD19-targeting CAR T cells | Biological | S1904 CD19 CAR-T |
Primary outcome
Objective response rate after S1904 infusion [Effectiveness]
Time frame: 3 months
Independent Review Committee (IRC)-assessed ORR (CR + CRi) at Month 3 post-infusion, as per ALL Response Criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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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.
Xiaojun Huang principal investigator
Peking University People's Hospital
Hongsheng Zhou principal investigator
Nanfang Hospital, Southern Medical University
Ruidong Zhang principal investigator
Beijing Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S1904 CD19 CAR-T in people with B-ALL, run by Hebei Senlang Biotechnology Inc., 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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 phase mean?
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?
Contact Xiaojun Huang (010-88325229, xjhrm@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate after S1904 infusion [Effectiveness] (time frame: 3 months). 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 24 Nov 2025.