T Lymphoblastic Leukemia/LymphomaPhase 2NCT07244380
Phase II Trial of S101 Autologous Anti-CD7 CAR-T Cells in Patients With R/R T-LBL/ALL.
A Phase 2 study testing Autologous CD7-targeting CAR T cells in people with T Lymphoblastic Leukemia/Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd..
Trial summary
To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL/ALL. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T Lymphoblastic Leukemia/Lymphoma
- What is being tested?
- Autologous CD7-targeting CAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2025to 30 Jun 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.The subject or guardian must provide voluntary informed consent; 2.Heavily pretreated patients with relapsed or refractory T-LBL/ALL who lack effective therapeutic alternatives; 3.At screening, CD7 positivity of tumor cells must be documented by flow cytometry (on bone marrow or peripheral blood samples) and/or by immunohistochemistry (IHC) confirming CD7 expression on an extramedullary lesion biopsy; 4.If malignant cells are detected in the peripheral blood at screening, they must demonstrate a CD4-negative and CD8-negative (double-negative) immunophenotype as assessed by flow cytometry; 5.Male or female subjects, aged 18 to 75 years (inclusive); 6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; 7.Estimated survival time>12 weeks.
Who cannot join
- 1.Patients with a history of allogeneic hematopoietic stem cell transplantation within the past 6 months are excluded; 2.Active or uncontrolled infection requiring systemic treatment at screening, excluding mild genitourinary and upper respiratory infections； 3.Participation in another clinical trial within 4 weeks prior to signing the informed consent form (ICF), OR the date of ICF signing occurring within 5 half-lives of the last dose from a previous investigational drug trial (whichever timeframe is longer); 4.Patients with previous treatment involving CAR-T cells or other gene-modified cell therapies are excluded; 5.Patients with acute GVHD (aGVHD) or moderate-to-severe chronic GVHD (cGVHD) within 4 weeks prior to screening, or those who have received systemic pharmacologic therapy for GVHD within 4 weeks prior to infusion; 6.Patients who have received extensive radiotherapy within 4 weeks prior to ICF signing, with the exception of non-target lesion radiotherapy administered for symptomatic palliation that may be permitted during the study period; 7.Women who are pregnant or lactating; 8.Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Clinical Trial of S101 Autologous CAR-T Cell Injection for the Treatment of CD7-Positive Relapsed or Refractory T-Lymphoblastic Lymphoma/Leukemia (T-LBL/ALL).
To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL/ALL.
Read the detailed description
This study is a Phase II, single-arm, open-label, single-infusion clinical trial designed to evaluate the clinical efficacy and safety of S101 in patients with CD7-positive relapsed or refractory T-lymphoblastic lymphoma/leukemia (T-LBL/ALL).
The primary objective： To evaluate the efficacy of S101 in patients with relapsed or refractory T-LBL/ALL.
The secondary objectives： To further characterize the efficacy, safety, pharmacokinetics and pharmacodynamics of S101 in this patient population.
- Conditions
- T Lymphoblastic Leukemia/Lymphoma
- Being tested
- Autologous CD7-targeting CAR T cells
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CD7-targeting CAR T cellsBiological
Autologous CD7-targeting CAR T cells, dosage 2*10^6/kg, intravenous injection once
| Study group | Role | What they receive |
|---|---|---|
| S101 CD7 CAR-T | Experimental | Autologous CD7-targeting CAR T cells, dosage 2*10^6/kg, intravenous injection once Receives: Biological: Autologous CD7-targeting CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate after S101 infusion [Effectiveness]
Independent Review Committee (IRC)-assessed ORR at Month 3 post-infusion.
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 start28 Nov 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Lymphoblastic Leukemia/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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiangyu Zhao, Principal investigator, Peking University People's HospitalWeili Zhao, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244380
- Sponsor's protocol ID
- CARMA-II
- 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 Clinical Trial of S101 Autologous CAR-T Cell Injection for the Treatment of CD7-Positive Relapsed or Refractory T-Lymphoblastic Lymphoma/Leukemia (T-LBL/ALL).
- ClinicalTrials.gov ID
- NCT07244380
- Acronym / sponsor ID
- CARMA-II
- Conditions
- T Lymphoblastic Leukemia/Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Jun 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 S101 for Treating CD7-Positive Relapsed or Refractory T-LBL/ALL.
Detailed description
This study is a Phase II, single-arm, open-label, single-infusion clinical trial designed to evaluate the clinical efficacy and safety of S101 in patients with CD7-positive relapsed or refractory T-lymphoblastic lymphoma/leukemia (T-LBL/ALL).
The primary objective： To evaluate the efficacy of S101 in patients with relapsed or refractory T-LBL/ALL.
The secondary objectives： To further characterize the efficacy, safety, pharmacokinetics and pharmacodynamics of S101 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 |
|---|---|---|
| S101 CD7 CAR-T | Experimental | Biological: Autologous CD7-targeting CAR T cellsAutologous CD7-targeting CAR T cells, dosage 2*10^6/kg, intravenous injection once |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.The subject or guardian must provide voluntary informed consent; 2.Heavily pretreated patients with relapsed or refractory T-LBL/ALL who lack effective therapeutic alternatives; 3.At screening, CD7 positivity of tumor cells must be documented by flow cytometry (on bone marrow or peripheral blood samples) and/or by immunohistochemistry (IHC) confirming CD7 expression on an extramedullary lesion biopsy; 4.If malignant cells are detected in the peripheral blood at screening, they must demonstrate a CD4-negative and CD8-negative (double-negative) immunophenotype as assessed by flow cytometry; 5.Male or female subjects, aged 18 to 75 years (inclusive); 6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; 7.Estimated survival time>12 weeks.
Key exclusion criteria (1 listed)
- 1.Patients with a history of allogeneic hematopoietic stem cell transplantation within the past 6 months are excluded; 2.Active or uncontrolled infection requiring systemic treatment at screening, excluding mild genitourinary and upper respiratory infections； 3.Participation in another clinical trial within 4 weeks prior to signing the informed consent form (ICF), OR the date of ICF signing occurring within 5 half-lives of the last dose from a previous investigational drug trial (whichever timeframe is longer); 4.Patients with previous treatment involving CAR-T cells or other gene-modified cell therapies are excluded; 5.Patients with acute GVHD (aGVHD) or moderate-to-severe chronic GVHD (cGVHD) within 4 weeks prior to screening, or those who have received systemic pharmacologic therapy for GVHD within 4 weeks prior to infusion; 6.Patients who have received extensive radiotherapy within 4 weeks prior to ICF signing, with the exception of non-target lesion radiotherapy administered for symptomatic palliation that may be permitted during the study period; 7.Women who are pregnant or lactating; 8.Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results.
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 |
|---|---|---|
| Autologous CD7-targeting CAR T cellsAutologous CD7-targeting CAR T cells, dosage 2*10^6/kg, intravenous injection once | Biological | S101 CD7 CAR-T |
Primary outcome
Objective response rate after S101 infusion [Effectiveness]
Time frame: 3 months
Independent Review Committee (IRC)-assessed ORR at Month 3 post-infusion.
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.
Related trials for T Lymphoblastic Leukemia/Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
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.
Xiangyu Zhao principal investigator
Peking University People's Hospital
Weili Zhao principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous CD7-targeting CAR T cells in people with T Lymphoblastic Leukemia/Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd..
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: opening soon, 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.
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 Xiangyu Zhao (01088325229, Zhao_xy@bjmu.edu.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 S101 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.