R/R Aggressive B-cell LymphomaEarly Phase 1NCT07344818
An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma
A Early Phase 1 study testing CAR-T cell therapy in people with R/R Aggressive B-cell Lymphoma, run by Peking University People's Hospital at 1 site in China.
Trial summary
To observe the efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory or relapsed aggressive B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- R/R Aggressive B-cell Lymphoma
- What is being tested?
- CAR-T cell therapy
- 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
- 7 Jan 2026to 31 May 2028
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF).
- Male or female subjects aged ≥18 years at the time of signing the ICF.
- An expected life expectancy of at least 12 weeks.
- An ECOG performance status of 0-2 at the time of signing the ICF.
- A diagnosis of relapsed or refractory aggressive B-cell lymphoma at the time of signing the ICF. Subjects must have previously received treatment with anthracycline-containing chemotherapy and rituximab (or other CD20-targeted agents), and must have experienced relapse or progression after at least two prior lines of therapy or autologous hematopoietic stem cell transplantation (ASCT).
- Presence of measurable positive lesions as defined by the Lugano criteria.
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- Lymphoma lesions confirmed by biopsy to screening demonstrating expression of CD19 and/or CD20.
- Adequate major organ function.
- contraception.
Who cannot join
- Lymphoma involving only the central nervous system (CNS) (except for secondary CNS lymphoma).
- History of CNS disorders.
- History of autoimmune disease requiring systemic immunosuppressive therapy within 4 weeks prior to signing the ICF.
- Presence of any uncontrolled active infection at the time of signing the ICF or within 2 weeks prior to leukapheresis, requiring antibiotic, antiviral, or antifungal treatment.
- Evidence of active infection, including: HBV DNA、Positive anti-HCV antibody with detectable HCV RNA、Positive HIV antibody、Positive cytomegalovirus (CMV) DNA、Positive Epstein-Barr virus (EBV) DNA、Positive both treponemal-specific and non-specific serologic tests for syphilis.
- Clinically significant cardiovascular disease.
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- Known hypersensitivity to any component of the investigational products used in this study.
- Receipt of any disease-related investigational therapy or other systemic antitumor therapy prior to leukapheresis and within 5 half-lives of the drug.
- Requirement for systemic corticosteroids (at a dose equivalent to ≥20 mg/day of prednisone) or other immunosuppressive agents within 2 weeks prior to signing the ICF, within 2 weeks prior to leukapheresis, or during the study.
- Major surgery (excluding routine biopsy) within 4 weeks prior to signing the ICF, or planned major surgery during the study period.
- History of another primary malignancy within 5 years prior to signing the ICF, except for:
- Adequately treated and cured carcinoma in situ of the cervix;
- Localized basal cell carcinoma or squamous cell carcinoma of the skin.
- Receipt of a live attenuated vaccine within 4 weeks prior to signing the ICF, or planned vaccination with a live attenuated vaccine during the screening period.
- Any condition or complication that, in the investigator's opinion, may affect protocol compliance or make the subject unsuitable for participation in the study.
- Pregnant or breastfeeding women.
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, Beijing Municipality, 100044
Na Kuang, (86)18630160116, kuangna@senlangbio.com
About this study
To observe the efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory or relapsed aggressive B-cell lymphoma
Read the detailed description
In this study, anti-CD19 and anti-CD20 dual target CAR-T cell therapy will be explored for patients with relapsed/refractory aggressive B-cell lymphoma. In this study, the 3+3 dose climbing mode will be used to explore the safety and efficacy of dual-target CAR-T cells in r/r B-NHL therapy at different doses. The RP2D dose will be determined after the relevant data is summarized。
- Conditions
- R/R Aggressive B-cell Lymphoma
- Being tested
- CAR-T cell therapy
- Keywords
- CD19+CD20 dual CAR-T, B-NHL, CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cell therapyBiological
autologous CD19+CD20 dual CAR-T cells, single injection
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cells therapy | Experimental | eligible patients will be treated with CD19+CD20 dual CAR-T cells Receives: Biological: CAR-T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the safety of CD19⁺CD20 CAR-T therapy
To evaluate the incidence and severity of AEs and SAEs in the treatment of relapsed or refractory CD19 and/or CD20 positive aggressive B-cell lymphoma patients after infused the CD19+CD20 CAR-T cells
Measured: 1 year after CAR-T cells therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start7 Jan 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for R/R Aggressive B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A 3+3 dose-escalation design will be conducted across different dose levels (2E6/kg, 4E6/kg, 6E6/kg), followed by an expansion study after determination of the RP2D.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Senlang Biotechnology Co., LTD
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344818
- Sponsor's protocol ID
- CD19+CD20 dual CAR-T
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07344818
- Acronym / sponsor ID
- CD19+CD20 dual CAR-T
- Conditions
- R/R Aggressive B-cell Lymphoma
- Keywords
- CD19+CD20 dual CAR-T, B-NHL, CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Hebei Senlang Biotechnology Co., LTD
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 15 Jan 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.
To observe the efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory or relapsed aggressive B-cell lymphoma
Detailed description
In this study, anti-CD19 and anti-CD20 dual target CAR-T cell therapy will be explored for patients with relapsed/refractory aggressive B-cell lymphoma. In this study, the 3+3 dose climbing mode will be used to explore the safety and efficacy of dual-target CAR-T cells in r/r B-NHL therapy at different doses. The RP2D dose will be determined after the relevant data is summarized。
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 3+3 dose-escalation design will be conducted across different dose levels (2E6/kg, 4E6/kg, 6E6/kg), followed by an expansion study after determination of the RP2D.
| Arm | Type | Receives |
|---|---|---|
| CAR-T cells therapy | Experimental | Biological: CAR-T cell therapyeligible patients will be treated with CD19+CD20 dual CAR-T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF).
- Male or female subjects aged ≥18 years at the time of signing the ICF.
- An expected life expectancy of at least 12 weeks.
- An ECOG performance status of 0-2 at the time of signing the ICF.
- A diagnosis of relapsed or refractory aggressive B-cell lymphoma at the time of signing the ICF. Subjects must have previously received treatment with anthracycline-containing chemotherapy and rituximab (or other CD20-targeted agents), and must have experienced relapse or progression after at least two prior lines of therapy or autologous hematopoietic stem cell transplantation (ASCT).
Key exclusion criteria (16 listed)
- Lymphoma involving only the central nervous system (CNS) (except for secondary CNS lymphoma).
- History of CNS disorders.
- History of autoimmune disease requiring systemic immunosuppressive therapy within 4 weeks prior to signing the ICF.
- Presence of any uncontrolled active infection at the time of signing the ICF or within 2 weeks prior to leukapheresis, requiring antibiotic, antiviral, or antifungal treatment.
- Evidence of active infection, including: HBV DNA、Positive anti-HCV antibody with detectable HCV RNA、Positive HIV antibody、Positive cytomegalovirus (CMV) DNA、Positive Epstein-Barr virus (EBV) DNA、Positive both treponemal-specific and non-specific serologic tests for syphilis.
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 |
|---|---|---|
| CAR-T cell therapyautologous CD19+CD20 dual CAR-T cells, single injection | Biological | CAR-T cells therapy |
Primary outcome
the safety of CD19⁺CD20 CAR-T therapy
Time frame: 1 year after CAR-T cells therapy
To evaluate the incidence and severity of AEs and SAEs in the treatment of relapsed or refractory CD19 and/or CD20 positive aggressive B-cell lymphoma patients after infused the CD19+CD20 CAR-T cells
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 15 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAR-T cell therapy in people with R/R Aggressive B-cell Lymphoma, run by Peking University People's 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 9 inclusion and 16 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 15 Jan 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Xiaodong Mo, PhD ((86)010-88325531, mxd453@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the safety of CD19⁺CD20 CAR-T therapy (time frame: 1 year after CAR-T cells therapy). 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 15 Jan 2026.