B-cell LymphomaPhase 1NCT07775508
In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed/Refractory B-Cell Lymphoma
A Phase 1 study testing SL1617 Injection in people with B-cell Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety and tolerability of SL1617 Injection in patients with relapsed or refractory B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-cell Lymphoma
- What is being tested?
- SL1617 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jan 2029
- Phase
- Phase 1
- 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 voluntarily agrees to participate in the study, has signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, and other study procedures.
- 2. Patients with B-cell lymphoma confirmed by cytological or histopathological examination according to the 2022 World Health Organization classification, meeting all of the following criteria:
- Lymphoma cells are confirmed to express CD19 and/or CD20 antigens by immunophenotyping or immunohistochemical examination.
- Eligible B-cell lymphomas include:
- Aggressive B-cell lymphomas, including large B-cell lymphoma (LBCL), Burkitt lymphoma (BL), and mantle cell lymphoma (MCL);
- Indolent B-cell lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), and hairy cell leukemia (HCL).
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- Relapsed or refractory B-cell lymphoma, defined as follows:
- Relapse: The patient has received adequate prior therapy and previously achieved a complete response (CR) or partial response (PR) after first-line systemic therapy (which must include an anti-CD20 monoclonal antibody and an anthracycline-containing chemotherapy regimen), second-line or subsequent systemic therapy, or autologous hematopoietic stem cell transplantation (ASCT), but relapsed after the completion of treatment, with disease progression confirmed by cytology or histology;
- Refractory: The patient failed to achieve CR or PR after first-line systemic therapy, or had no response to the most recent second-line or subsequent systemic therapy regimen, with progressive disease (PD) or stable disease (SD) as a best response of treatment.
- The patient must have at least one measurable lesion. If salvage therapy was administered after ASCT, the patient must have no response to the most recent salvage therapy or must have relapsed after the most recent salvage therapy. Patients with relapsed indolent lymphoma may be enrolled only if clinical indications for treatment are present, such as symptomatic mass lesions, organ compression, cytopenias, or B symptoms.
- 3. Male or female subjects aged 18-75 years, inclusive. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Estimated life expectancy of more than 3 months from the date of signing the informed consent form.
- 6. Absolute neutrophil count≥1×10^9/L, platelet count≥75×10^9/L, hemoglobin≥60g/L.
- 7. Adequate renal, hepatic, cardiac, and pulmonary function, defined as follows:
- Creatinine clearance (estimated by the Cockcroft-Gault formula) ≥60 mL/min;
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×upper limit of normal (ULN), total bilirubin≤1.5×ULN;
- Cardiac ejection fraction≥50%, no pericardial effusion on echocardiography, and no significant abnormalities on electrocardiogram (ECG);
- No clinically significant pleural effusion, and oxygen saturation >92% on room air at baseline.
- 8. Subjects agree to use effective contraception from the time of signing the informed consent form until 1 year after cell infusion.
Who cannot join
- 1. The patient has severe cardiac dysfunction, or left ventricular ejection fraction (LVEF) <50%, or a history within the 12 months prior to enrollment of myocardial infarction, coronary angioplasty or coronary stent implantation, unstable angina, clinically significant arrhythmia, or other severe cardiovascular diseases.
- 2. A history of severe pulmonary dysfunction or severe pulmonary disease associated with impaired lung function.
- 3. The patient has a history of malignancies other than B-cell lymphoma, and is ineligible unless they have been disease-free and have not received any form of antineoplastic therapy for at least 3 consecutive years.
- 4. Severe active infection that cannot be effectively controlled. 5. The patient has severe autoimmune disease, congenital immunodeficiency or active autoimmune disease requiring ongoing treatment, or is currently within the washout period after having received medications that may affect CAR-T cell immunotherapy, or is anticipated to require medications during the study period that may affect CAR-T cell immunotherapy treatment.
- 6. The patient has tuberculosis infection, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) infection; has received a live vaccine within 4 weeks, or is anticipated to require a live vaccine during the study period.
- 7. The patient has previously undergone allogeneic hematopoietic stem cell transplantation, solid organ allogeneic transplantation, or allogeneic cell therapy.
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- 8. A history of severe allergic reactions to biological products, including antibiotics.
- 9. The patient has other significant uncontrolled comorbidities that may affect protocol compliance or interpretation of results.
- 10. The investigator judges that the patient is unlikely to complete all visits and procedures required by the study protocol (including medium- and long-term follow-up visits), such as insufficient willingness of the patient and their family members to participate in the study, refusal to participate, inability of the patient to fully cooperate with the study arrangements, or inadequate compliance on the part of the patient and their family members.
- 11. Any other severe physical or psychiatric disorder or clinically significant laboratory abnormality that may increase the risk associated with study participation, interfere with the interpretation of study results, or, in the investigator's judgment, make the patient unsuitable for participation in the study.
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
Chinese PLA General Hospital, Beijing, Beijing 100853
Beijing
About this study
Official title: A Clinical Study on the Safety of in Vivo- CAR-T Cell Immunotherapy Targeting CD19/CD20 for the Treatment of Relapsed/Refractory B-cell Lymphoma
This Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety and tolerability of SL1617 Injection in patients with relapsed or refractory B-cell lymphoma. SL1617 is an investigational in vivo CAR T-cell immunotherapy targeting CD19 and CD20, utilizing an engineered lentiviral vector to generate functional CAR-T cells in vivo without the need for ex vivo cell processing or lymphodepletion. Participants will receive a single intravenous infusion of SL1617 using a traditional 3+3 dose-escalation design. The planned starting dose is 1.0 × 10^9 transducing units (TU), followed by dose levels of 3.0 × 10^9 TU and 6.0 × 10^9 TU. Dose escalation will be guided by the occurrence of dose-limiting toxicities (DLTs).
Read the detailed description
This Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety and tolerability of SL1617 Injection in patients with relapsed or refractory B-cell lymphoma. SL1617 Injection is an investigational in vivo CAR T-cell immunotherapy targeting CD19 and CD20, based on an engineered lentiviral vector system. The vector is designed to specifically target and transduce T cells and NK cells in vivo, enabling in situ generation of functional CAR-expressing immune cells following a single intravenous infusion SL1617 Injection will be administered as a single intravenous infusion. Dose escalation will follow a traditional 3+3 design. The planned starting dose is 1.0 × 10^9 transducing units (TU), followed sequentially by dose levels of 3.0 × 10^9 TU and 6.0 × 10^9 TU.
At each dose level, three participants will initially be enrolled. If none of the first three participants experiences a dose-limiting toxicity (DLT), enrollment may proceed to the next dose level. If two or more of the first three participants experience a DLT, further dose escalation will be stopped.
If one of the first three participants experiences a DLT, three additional participants will be enrolled at the same dose level. Dose escalation may proceed if none of the three additional participants experiences a DLT. Dose escalation will be stopped if at least one of the three additional participants experiences a DLT, resulting in DLTs in at least two of six participants at that dose level.
If the maximum tolerated dose (MTD) is not reached after completion of the DLT observation period for the 6.0 × 10^9 TU dose cohort, the investigators may explore higher dose levels based on cumulative safety data and pharmacodynamic evidence.
The primary objective is to evaluate the safety of SL1617 Injection, including the incidence and severity of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, hematologic toxicity, organ toxicity, and other treatment-related adverse events. Secondary objectives include assessment of preliminary antitumor activity using objective response rate, complete response rate, partial response rate, overall survival, progression-free survival, and event-free survival. Exploratory objectives include characterization of in vivo CAR-T cell kinetics (CAR copy number, Cmax, Tmax, and AUC28d) and clonal evolution.
- Conditions
- B-cell Lymphoma
- Being tested
- SL1617 Injection
- Keywords
- in vivo CAR-T, CD19, CD20, SL1617, lentiviral vector, immunotherapy, B-cell lymphoma
- 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.
SL1617 InjectionDrug
Participants with relapsed or refractory B-cell lymphoma will receive SL1617 Injection, an investigational in vivo CD19/CD20-targeted CAR T-cell immunotherapy, by intravenous infusion according to the protocol. Participants will subsequently undergo safety and efficacy assessments for up to 24 months after treatment.
| Study group | Role | What they receive |
|---|---|---|
| SL1617 Treatment | Experimental | Not described Receives: Drug: SL1617 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
The number, percentage, and severity of adverse events (AEs) following SL1617 Injection infusion, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, organ toxicity, and other immune therapy-related toxicities, graded per CTCAE v6.0.
Measured: From SL1617 infusion through 24 months after treatment
Incidence of Dose-Limiting Toxicities (DLTs)
The number and percentage of participants who experience DLTs during the protocol-defined DLT observation period (Days 1-28) following a single intravenous infusion of SL1617 Injection.
Measured: During the protocol-defined DLT observation period after SL1617 infusion
Secondary outcomes (6)
Objective Response Rate at Prespecified Follow-up Time Points
The objective response rate (ORR) at 1, 3, 6, 9, 12, 18, and 24 months after treatment, defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
Measured: At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion
Complete Response Rate
The proportion of participants who achieve a complete response at each prespecified assessment time point.
Measured: At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion
Partial Response Rate
The proportion of participants who achieve a partial response at each prespecified assessment time point.
Measured: At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion
Overall Survival
Overall survival (OS), defined as the time from SL1617 infusion to death from any cause. Participants who are alive at the last follow-up will be censored on the date of their last known survival status.
Measured: From SL1617 infusion through 24 months after treatment
Progression-Free Survival
Progression-free survival (PFS), defined as the time from SL1617 infusion to the first documented disease progression or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last disease assessment.
Measured: From SL1617 infusion through 24 months after treatment
Event-Free Survival
Event-free survival (EFS), defined as the time from SL1617 infusion to the occurrence of a protocol-defined event, including disease progression, relapse, initiation of new anti-lymphoma therapy, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last follow-up.
Measured: From SL1617 infusion through 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Senlang Biotechnology Inc., Ltd.
- Responsible party
- Principal investigator, Liping Dou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775508
- Sponsor's protocol ID
- 2026-174
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety of in Vivo- CAR-T Cell Immunotherapy Targeting CD19/CD20 for the Treatment of Relapsed/Refractory B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07775508
- Acronym / sponsor ID
- 2026-174
- Conditions
- B-cell Lymphoma
- Keywords
- in vivo CAR-T, CD19, CD20, SL1617, lentiviral vector, immunotherapy, B-cell lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Hebei Senlang Biotechnology Inc., Ltd.
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 20 Aug 2026 (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 Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety and tolerability of SL1617 Injection in patients with relapsed or refractory B-cell lymphoma. SL1617 is an investigational in vivo CAR T-cell immunotherapy targeting CD19 and CD20, utilizing an engineered lentiviral vector to generate functional CAR-T cells in vivo without the need for ex vivo cell processing or lymphodepletion. Participants will receive a single intravenous infusion of SL1617 using a traditional 3+3 dose-escalation design. The planned starting dose is 1.0 × 10^9 transducing units (TU), followed by dose levels of 3.0 × 10^9 TU and 6.0 × 10^9 TU. Dose escalation will be guided by the occurrence of dose-limiting toxicities (DLTs).
Detailed description
This Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety and tolerability of SL1617 Injection in patients with relapsed or refractory B-cell lymphoma. SL1617 Injection is an investigational in vivo CAR T-cell immunotherapy targeting CD19 and CD20, based on an engineered lentiviral vector system. The vector is designed to specifically target and transduce T cells and NK cells in vivo, enabling in situ generation of functional CAR-expressing immune cells following a single intravenous infusion SL1617 Injection will be administered as a single intravenous infusion. Dose escalation will follow a traditional 3+3 design. The planned starting dose is 1.0 × 10^9 transducing units (TU), followed sequentially by dose levels of 3.0 × 10^9 TU and 6.0 × 10^9 TU.
At each dose level, three participants will initially be enrolled. If none of the first three participants experiences a dose-limiting toxicity (DLT), enrollment may proceed to the next dose level. If two or more of the first three participants experience a DLT, further dose escalation will be stopped.
If one of the first three participants experiences a DLT, three additional participants will be enrolled at the same dose level. Dose escalation may proceed if none of the three additional participants experiences a DLT. Dose escalation will be stopped if at least one of the three additional participants experiences a DLT, resulting in DLTs in at least two of six participants at that dose level.
If the maximum tolerated dose (MTD) is not reached after completion of the DLT observation period for the 6.0 × 10^9 TU dose cohort, the investigators may explore higher dose levels based on cumulative safety data and pharmacodynamic evidence.
The primary objective is to evaluate the safety of SL1617 Injection, including the incidence and severity of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, hematologic toxicity, organ toxicity, and other treatment-related adverse events. Secondary objectives include assessment of preliminary antitumor activity using objective response rate, complete response rate, partial response rate, overall survival, progression-free survival, and event-free survival. Exploratory objectives include characterization of in vivo CAR-T cell kinetics (CAR copy number, Cmax, Tmax, and AUC28d) and clonal evolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SL1617 Treatment | Experimental | Drug: SL1617 Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1. The subject voluntarily agrees to participate in the study, has signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, and other study procedures.
- 2. Patients with B-cell lymphoma confirmed by cytological or histopathological examination according to the 2022 World Health Organization classification, meeting all of the following criteria:
- 3. Male or female subjects aged 18-75 years, inclusive. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Estimated life expectancy of more than 3 months from the date of signing the informed consent form.
- 6. Absolute neutrophil count≥1×10^9/L, platelet count≥75×10^9/L, hemoglobin≥60g/L.
- 8. Subjects agree to use effective contraception from the time of signing the informed consent form until 1 year after cell infusion.
Key exclusion criteria (10 listed)
- 1. The patient has severe cardiac dysfunction, or left ventricular ejection fraction (LVEF) <50%, or a history within the 12 months prior to enrollment of myocardial infarction, coronary angioplasty or coronary stent implantation, unstable angina, clinically significant arrhythmia, or other severe cardiovascular diseases.
- 2. A history of severe pulmonary dysfunction or severe pulmonary disease associated with impaired lung function.
- 3. The patient has a history of malignancies other than B-cell lymphoma, and is ineligible unless they have been disease-free and have not received any form of antineoplastic therapy for at least 3 consecutive years.
- 4. Severe active infection that cannot be effectively controlled. 5. The patient has severe autoimmune disease, congenital immunodeficiency or active autoimmune disease requiring ongoing treatment, or is currently within the washout period after having received medications that may affect CAR-T cell immunotherapy, or is anticipated to require medications during the study period that may affect CAR-T cell immunotherapy treatment.
- 6. The patient has tuberculosis infection, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) infection; has received a live vaccine within 4 weeks, or is anticipated to require a live vaccine during the study period.
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 |
|---|---|---|
| SL1617 InjectionParticipants with relapsed or refractory B-cell lymphoma will receive SL1617 Injection, an investigational in vivo CD19/CD20-targeted CAR T-cell immunotherapy, by intravenous infusion according to the protocol. Participants will subsequently undergo safety and efficacy assessments for up to 24 months after treatment. | Drug | SL1617 Treatment |
Primary outcome
Incidence and Severity of Adverse Events
Time frame: From SL1617 infusion through 24 months after treatment
The number, percentage, and severity of adverse events (AEs) following SL1617 Injection infusion, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, organ toxicity, and other immune therapy-related toxicities, graded per CTCAE v6.0.
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: During the protocol-defined DLT observation period after SL1617 infusion
The number and percentage of participants who experience DLTs during the protocol-defined DLT observation period (Days 1-28) following a single intravenous infusion of SL1617 Injection.
6 secondary outcomes
Objective Response Rate at Prespecified Follow-up Time Points
Time frame: At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion
Complete Response Rate
Time frame: At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion
Partial Response Rate
Time frame: At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion
Overall Survival
Time frame: From SL1617 infusion through 24 months after treatment
Progression-Free Survival
Time frame: From SL1617 infusion through 24 months after treatment
Event-Free Survival
Time frame: From SL1617 infusion through 24 months after treatment
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SL1617 Injection in people with B-cell Lymphoma, run by Chinese PLA General Hospital 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 18 inclusion and 10 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 20 Aug 2026. 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 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.
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 Li-Ping Dou, Dr. (86-010-66937232, lipingruirui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (time frame: From SL1617 infusion through 24 months after treatment). The study lists 2 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 20 Aug 2026.