ClinicalTrials.gg
RecruitingNCT07775508Updated Aug 20, 2026

In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed/Refractory B-Cell Lymphoma

A Phase 1 interventional study of SL1617 Injection in B-cell Lymphoma, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Chinese PLA General Hospital · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 283 studies in Lymphoma, B-Cell with a site in China — 125 open to participants now, 146 under way, 9 of them phase 3. Lymphoma, B-Cell · China.

Planned enrollment
203rd of 273
18 · median 30
Started
2026
with 25 others
Phase 1
124 of 283
57 open now
Primary completion
2027-04
later than 77 of 145 live
Registered
280th of 283
by date
Lead sponsor
8 of 283
Chinese PLA General Hospital

Among the 283 studies in Lymphoma, B-Cell with a site in China, this one is the 203rd largest by planned enrollment of the 273 interventional ones that give a count, is one of 26 that started in 2026, is one of 124 in phase 1, reaches primary completion later than 77 of the 145 other live ones, and was the 280th registered.

Lymphoma, B-Cell

885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.

Browse Lymphoma, B-Cell studies →

Open to participants now

125 of the 283 studies in Lymphoma, B-Cell with a site in China are open now. Recruiting first, the newest first:

119 more — sign in →

All 125 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 209 Lymphoma, B-Cell studies recruiting now, 129 (62%) set no upper age limit and 60 (29%) stop at 75 or younger; 37 take children under 18; 3 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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. 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.

03

Conditions studied

  • B-cell Lymphoma

Browse trials for

Keywords

  • in vivo CAR-T
  • CD19
  • CD20
  • SL1617
  • lentiviral vector
  • immunotherapy
  • B-cell lymphoma
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 1. The subject voluntarily agrees to participate in the study, has signed the 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:

    1. Lymphoma cells are confirmed to express CD19 and/or CD20 antigens by immunophenotyping or immunohistochemical examination.
    2. 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).
    3. 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 systemic therapy (which must include an anti-CD20 monoclonal antibody and an anthracycline-containing chemotherapy regimen), second-line or subsequent systemic therapy, or 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.
    4. The patient must have at least one . 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. (ECOG) performance status of 0-2. 5. Estimated of more than 3 months from the date of signing the informed consent form.

    6. ≥1×10\^9/L, count≥75×10\^9/L, ≥60g/L.

    7. Adequate renal, hepatic, cardiac, and pulmonary function, defined as follows:

    1. (estimated by the Cockcroft-Gault formula) ≥60 mL/min;
    2. Serum (ALT) and aspartate aminotransferase (AST)≤2.5× (ULN), total ≤1.5×ULN;
    3. Cardiac ≥50%, no pericardial effusion on echocardiography, and no significant abnormalities on (ECG);
    4. No pleural effusion, and oxygen saturation >92% on room air at baseline.

    8. Subjects agree to use effective from the time of signing the informed consent form until 1 year after cell infusion.

Exclusion criteria

Exclusion Criteria:

  • 1. The patient has severe cardiac dysfunction, or (LVEF) \<50%, or a history within the 12 months prior to enrollment of myocardial infarction, coronary angioplasty or coronary stent implantation, unstable angina, 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 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 disease, congenital immunodeficiency or active autoimmune disease requiring ongoing treatment, or is currently within the 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 virus (HBV) infection, active virus (HCV) infection, or (HIV) infection; has received a within 4 weeks, or is anticipated to require a live vaccine during the study period.

    7. The patient has previously undergone hematopoietic stem cell transplantation, solid organ allogeneic transplantation, or allogeneic cell therapy.

    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.

Terms in these criteria, in plain language(25)

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.

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.

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.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

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.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

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.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    SL1617 Treatment

    Drug: SL1617 Injection

Interventions

  • DrugSL1617 Injection

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From SL1617 infusion through 24 months after treatment

  2. 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.

    Time frame: During the protocol-defined DLT observation period after SL1617 infusion

Secondary outcomes

  1. 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).

    Time frame: At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion

  2. Complete Response Rate

    The proportion of participants who achieve a complete response at each prespecified assessment time point.

    Time frame: At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion

  3. Partial Response Rate

    The proportion of participants who achieve a partial response at each prespecified assessment time point.

    Time frame: At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion

  4. 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.

    Time frame: From SL1617 infusion through 24 months after treatment

  5. 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.

    Time frame: From SL1617 infusion through 24 months after treatment

  6. 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.

    Time frame: From SL1617 infusion through 24 months after treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Apr 2027, 10 months after the start.

Of 117 non-industry phase 1 interventional studies under Lymphoma, B-Cell, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 75. This study's planned 10 months is below that.

Counting every sponsor, half of 207 studies reached it within 51 months; a quarter within 37 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
Jun 1, 2026
Primary completionEst.
Apr 1, 2027
CompletionEst.
Jan 1, 2029
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07775508
Responsible party
Liping Dou (Chief Physician, Professor, and Director of the Department of Hematology, Chinese PLA General Hospital) — Principal investigator
First posted
Aug 20, 2026
Start date
Jun 1, 2026
Primary completion
Apr 1, 2027 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Aug 20, 2026

Study contacts

Li-Ping Dou, Dr.
Contact
lipingruirui@163.com
86-010-66937232

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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