Relapsed/Refractory B-Cell LymphomaEarly Phase 1NCT07546630
Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell Therapy of Relapsed/Refractory B-Cell Lymphoma
A Early Phase 1 study testing CD19/CD20 Tandem Dual CAR-T in people with Relapsed/Refractory B-Cell Lymphoma, run by Affiliated Hospital to Academy of Military Medical Sciences.
Trial summary
This is a single arm study to evaluate the safety and efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for Relapsed/Refractory B-Cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory B-Cell Lymphoma
- What is being tested?
- CD19/CD20 Tandem Dual CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 1 May 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has voluntarily signed the informed consent form with full consent, and is willing and able to comply with the scheduled visits, study treatments, laboratory tests, and other trial procedures
- Patients with relapsed/refractory B-cell lymphoma confirmed by cytology or histology according to the WHO 2022 Classification:
- Lymphoma cells confirmed to express CD19 and/or CD20 antigen by immunophenotyping or histopathological immunohistochemistry
- B-cell lymphomas include: aggressive B-cell lymphomas (LBCL, BL, MCL) and indolent B-cell lymphomas (CLL/SLL, FL, MZL, LPL, HCL)
- Relapsed/refractory B-cell lymphoma: For patients with aggressive lymphoma, disease stable for ≤12 months or disease progression after achieving best response following at least first- and second-line pharmacotherapy; or disease progression or relapse within ≤12 months after autologous stem cell transplantation. For patients with indolent lymphoma, disease progression, relapse or transformation following at least three lines of prior therapy
- Aged 18-75 years (inclusive), male or female
Show all 15Show fewer
- Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- Estimated overall survival of more than 3 months from the date of signing the informed consent form
- Hemoglobin (HGB) ≥ 70 g/L (transfusion permitted)
- Adequate hepatic, renal and cardiopulmonary function meeting the following criteria:
- Creatinine ≤ 1.5 × ULN;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- Blood oxygen saturation > 90%;
- Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN
- The subject agrees to use contraceptive measures from the date of signing the informed consent form until 1 year after CAR-T cell infusion
Who cannot join
- Severe cardiac insufficiency with left ventricular ejection fraction < 50%
- History of severe pulmonary function-impairing diseases
- Concomitant other advanced malignant neoplasms
- Concomitant severe infection that cannot be effectively controlled
- Concomitant severe autoimmune diseases or congenital immunodeficiency disorders
- Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA] or hepatitis C virus ribonucleic acid [HCV-RNA] test result above the lower limit of detection)
Show all 9Show fewer
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection
- History of severe allergy to biological products (including antibiotics)
- Patients with allogeneic hematopoietic stem cell transplantation who still have acute graft-versus-host disease (GVHD) after one month of discontinuation of immunosuppressive agents
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: Clinical Study on the Safety and Efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell Therapy for Relapsed/Refractory B-Cell Lymphoma
This is a single arm study to evaluate the safety and efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for Relapsed/Refractory B-Cell Lymphoma
- Conditions
- Relapsed/Refractory B-Cell Lymphoma
- Being tested
- CD19/CD20 Tandem Dual CAR-T
- Keywords
- Relapsed/Refractory B-Cell Lymphoma, Nanobody, CD19, CD20, CAR-T
- 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.
CD19/CD20 Tandem Dual CAR-TGenetic
Each subject will be infused with single dose of CD19/CD20 Tandem Dual CAR-T. A classic "3+3" dose escalation will be employed. The low dose is 2×10^6 / kg, the medium dose is 4×10^6 /kg, and the high dose is 6×10^6 /kg.
| Study group | Role | What they receive |
|---|---|---|
| This is a single arm treatment of CD19/CD20 Tandem Dual CAR-T | Experimental | Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy. Investigational product: CD19/CD20 Tandem Dual CAR-T. Route of administration: Intravenous injection. Lymphodepleting chemotherapy regimen: Acombination of fludarabine and cyclophosphamide will be administered prior to the infusion of CD19/CD20 Tandem Dual CAR-T. Receives: Genetic: CD19/CD20 Tandem Dual CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
According to the incidence of treatment-related adverse events (AEs) to evaluate the safety of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma.
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
Measured: up to 3 years
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma.
Measured: MTD will be determined based on DLTs observed during the first 28 days of study treatment
Secondary outcomes (1)
According to the objective response rate (ORR) to evaluate the efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma.
Overall Response Rate (ORR) Description:For B-cell lymphoma, ORR is defined according to the Lugano Classification for Lymphoma Response Assessment. ORR represents the proportion of patients achieving complete response (CR) or partial response (PR).
Measured: Within 3 months following infusion of CD19/CD20 Tandem Dual CAR-T
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory B-Cell 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- A classic "3+3" dose escalation will be employed. The starting dose is 2×10\^6 cells/kg, followed by sequential escalated doses of 4×10\^6 cells/kg and 6×10\^6 cells/kg.If no dose-limiting toxicity (DLT) is observed in 3 subjects at a given dose cohort, the study may proceed to the next higher dose level. Dose escalation will be discontinued if DLT occurs in 2 or more out of 3 subjects. If 1 DLT event occurs in the initial 3 subjects, another 3 subjects will be enrolled at the same dose. Escalation may continue if no DLT occurs in the supplementary 3 subjects. Dose escalation shall not proceed if DLT occurs in any of the additional subjects, or if a total of 2 or more DLT cases occur among 6 subjects in the same cohort.DLT refers to reasonably treatment-related toxic reactions within the DLT assessment window (Day 1 to Day 28 after CAR-T infusion), and toxicity grading shall comply with CTCAE 5.0.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546630
- Sponsor's protocol ID
- VHH CAR2019-XYBYXB
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell Therapy for Relapsed/Refractory B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07546630
- Acronym / sponsor ID
- VHH CAR2019-XYBYXB
- Conditions
- Relapsed/Refractory B-Cell Lymphoma
- Keywords
- Relapsed/Refractory B-Cell Lymphoma, Nanobody, CD19, CD20, CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 23 Apr 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 is a single arm study to evaluate the safety and efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for Relapsed/Refractory B-Cell Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A classic "3+3" dose escalation will be employed. The starting dose is 2×10^6 cells/kg, followed by sequential escalated doses of 4×10^6 cells/kg and 6×10^6 cells/kg.If no dose-limiting toxicity (DLT) is observed in 3 subjects at a given dose cohort, the study may proceed to the next higher dose level. Dose escalation will be discontinued if DLT occurs in 2 or more out of 3 subjects. If 1 DLT event occurs in the initial 3 subjects, another 3 subjects will be enrolled at the same dose. Escalation may continue if no DLT occurs in the supplementary 3 subjects. Dose escalation shall not proceed if DLT occurs in any of the additional subjects, or if a total of 2 or more DLT cases occur among 6 subjects in the same cohort.DLT refers to reasonably treatment-related toxic reactions within the DLT assessment window (Day 1 to Day 28 after CAR-T infusion), and toxicity grading shall comply with CTCAE 5.0.
| Arm | Type | Receives |
|---|---|---|
| This is a single arm treatment of CD19/CD20 Tandem Dual CAR-T | Experimental | Genetic: CD19/CD20 Tandem Dual CAR-TNanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy. Investigational product: CD19/CD20 Tandem Dual CAR-T. Route of administration: Intravenous injection. Lymphodepleting chemotherapy regimen: Acombination of fludarabine and cyclophosphamide will be administered prior to the infusion of CD19/CD20 Tandem Dual CAR-T. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The subject has voluntarily signed the informed consent form with full consent, and is willing and able to comply with the scheduled visits, study treatments, laboratory tests, and other trial procedures
- Patients with relapsed/refractory B-cell lymphoma confirmed by cytology or histology according to the WHO 2022 Classification:
- Aged 18-75 years (inclusive), male or female
- Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- Estimated overall survival of more than 3 months from the date of signing the informed consent form
Key exclusion criteria (9 listed)
- Severe cardiac insufficiency with left ventricular ejection fraction < 50%
- History of severe pulmonary function-impairing diseases
- Concomitant other advanced malignant neoplasms
- Concomitant severe infection that cannot be effectively controlled
- Concomitant severe autoimmune diseases or congenital immunodeficiency disorders
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 |
|---|---|---|
| CD19/CD20 Tandem Dual CAR-TEach subject will be infused with single dose of CD19/CD20 Tandem Dual CAR-T. A classic "3+3" dose escalation will be employed. The low dose is 2×10^6 / kg, the medium dose is 4×10^6 /kg, and the high dose is 6×10^6 /kg. | Genetic | This is a single arm treatment of CD19/CD20 Tandem Dual CAR-T |
Primary outcome
According to the incidence of treatment-related adverse events (AEs) to evaluate the safety of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma.
Time frame: up to 3 years
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma.
Time frame: MTD will be determined based on DLTs observed during the first 28 days of study treatment
1 secondary outcome
According to the objective response rate (ORR) to evaluate the efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma.
Time frame: Within 3 months following infusion of CD19/CD20 Tandem Dual CAR-T
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 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Relapsed/Refractory B-Cell Lymphoma
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
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD19/CD20 Tandem Dual CAR-T in people with Relapsed/Refractory B-Cell Lymphoma, run by Affiliated Hospital to Academy of Military Medical Sciences.
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 15 inclusion and 9 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 29 Apr 2026. 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?
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 Yamei Wu (+86 01066947164, rippleya@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
According to the incidence of treatment-related adverse events (AEs) to evaluate the safety of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for CD20/CD19 positive relapsed/refractory B-Cell lymphoma. (time frame: up to 3 years). 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 29 Apr 2026.