R/R NHLEarly Phase 1NCT06879262
Clinical Study of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Relapsed/Refractory B-ALL and NHL
A Early Phase 1 study testing CAR1922T2 T cells（Targeting CD19 and CD22 with CAR-T cells） in people with R/R NHL, run by Tongji Hospital.
Trial summary
The purpose of this clinical trial is to evaluate the safety and efficacy of CAR1922T2 T-cell therapy in participants with relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- R/R NHL
- What is being tested?
- CAR1922T2 T cells（Targeting CD19 and CD22 with CAR-T cells）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 28 Feb 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The patient or their legal guardian voluntarily participates and signs an informed consent form.
- 2.Age between 18-80 years old (inclusive), with no gender restrictions. 3.Diagnosed with acute B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma according to the WHO 2016 classification.
- 4.CD19 or CD22 positivity confirmed by flow cytometry or histopathology. 5.Diagnosed with refractory/relapsed B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
- 6.Good major organ function:
- Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L;
- Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min;
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- Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, no clinically significant ECG abnormalities.
- 7.Women of childbearing age with negative urine/blood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion; male subjects with reproductive capacity must agree to use effective barrier contraceptive methods for at least 1 year after infusion.
- 8.ECOG score ≤ 1. 9.Life expectancy greater than 3 months.
Who cannot join
- 1.Women who are breastfeeding. 2.Patients with uncontrollable infectious diseases within 4 weeks before enrollment.
- 3.Active hepatitis B/C. 4.HIV-infected patients. 5.Patients with severe autoimmune diseases or immunodeficiency diseases. 6.Patients with allergic constitution, allergic to antibodies or cytokines and other large molecule biological drugs.
- 7.Patients who have participated in other clinical trials within 4 weeks before enrollment.
- 8.History of clinically significant central nervous system diseases: such as epilepsy, paralysis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes.
- 9.Patients with mental illness. 10.Patients with drug abuse/addiction. 11.Use of contraindicated medications.
- . Steroids: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent >20 mg/day) within 7 days before leukocyte collection, or within 72 hours before CAR-T cell infusion targeting CD19 and CD22. However, physiological replacement, topical, and inhaled corticosteroids are allowed.
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- . Chemotherapy: Received salvage chemotherapy within 2 weeks before leukocyte collection.
- . Allogeneic cell therapy: Received donor lymphocyte infusion within 4 weeks before leukocyte collection.
- . GVHD treatment: Received anti-GVHD treatment within 4 weeks before CAR-T cell infusion targeting CD19 and CD22.
- . Use of alemtuzumab, or cladribine within 6 months before leukocyte collection, or use of chlorambucil or clofarabine within 3 months.
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 of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Refractory/Relapsed B-Cell Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma
The purpose of this clinical trial is to evaluate the safety and efficacy of CAR1922T2 T-cell therapy in participants with relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma. Participants will receive a single infusion of CAR1922T2 T-cells and complete follow-ups over the next three years.
Read the detailed description
Acute lymphoblastic leukemia (ALL) is a hematological malignancy characterized by the clonal proliferation of precursor lymphoid cells, with a cure rate of only 30-40% in adults through standardized chemotherapy. Non-Hodgkin's lymphoma (NHL) is a highly heterogeneous group of lymphatic and reticular neoplasms derived from the clonal malignant proliferation of lymphoid cells, with 30-40% of patients developing into refractory disease or relapsing after initial treatment. Although CAR-T cell therapy targeting CD19 has made significant progress in the treatment of patients with refractory/relapsed B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma, more than 50% of patients treated with CAR19 experience disease progression, which is related to the loss of CD19 on the cell surface. Therefore, our research team has developed a dual-specific CAR-T cell targeting both CD19 and CD22 to enhance the tumor-killing ability of CAR-T cells.
This clinical trial aims to evaluate the effectiveness and safety of CAR-T cell therapy targeting CD19 and CD22 (CAR1922T2 T cells) in participants with refractory/relapsed B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma. After treatment with CAR1922T2 T cells, the effectiveness and safety of CAR1922T2 T-cell therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma will be assessed through clinical symptom evaluation, quality of life assessment, biomarker testing, laboratory testing, imaging evaluation, adverse event monitoring, and follow-up surveys.
- Conditions
- R/R NHL
- Being tested
- CAR1922T2 T cells（Targeting CD19 and CD22 with CAR-T cells）
- Keywords
- CAR-T, CAR1922T2 T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR1922T2 T cells（Targeting CD19 and CD22 with CAR-T cells）Biological
Administer a single infusion of CAR1922T2 T cells to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Administer a single infusion of CAR1922T2 T cells to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion, and conduct follow-up surveys at the required time points within three years post-infusion according to the visit schedule. Receives: Biological: CAR1922T2 T cells（Targeting CD19 and CD22 with CAR-T cells） |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The overall response rate (ORR) includes both complete response (CR) and partial response (PR), and uses the Clopper-Pearson method to calculate the two-sided 95% confidence interval.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start15 Feb 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for R/R NHLStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Wei, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879262
- Sponsor's protocol ID
- TJ-IRB202502060
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2025
- Last updated
- 6 Jan 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Refractory/Relapsed B-Cell Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06879262
- Acronym / sponsor ID
- TJ-IRB202502060
- Conditions
- R/R NHL
- Keywords
- CAR-T, CAR1922T2 T cells
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 17 Mar 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.
The purpose of this clinical trial is to evaluate the safety and efficacy of CAR1922T2 T-cell therapy in participants with relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma. Participants will receive a single infusion of CAR1922T2 T-cells and complete follow-ups over the next three years.
Detailed description
Acute lymphoblastic leukemia (ALL) is a hematological malignancy characterized by the clonal proliferation of precursor lymphoid cells, with a cure rate of only 30-40% in adults through standardized chemotherapy. Non-Hodgkin's lymphoma (NHL) is a highly heterogeneous group of lymphatic and reticular neoplasms derived from the clonal malignant proliferation of lymphoid cells, with 30-40% of patients developing into refractory disease or relapsing after initial treatment. Although CAR-T cell therapy targeting CD19 has made significant progress in the treatment of patients with refractory/relapsed B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma, more than 50% of patients treated with CAR19 experience disease progression, which is related to the loss of CD19 on the cell surface. Therefore, our research team has developed a dual-specific CAR-T cell targeting both CD19 and CD22 to enhance the tumor-killing ability of CAR-T cells.
This clinical trial aims to evaluate the effectiveness and safety of CAR-T cell therapy targeting CD19 and CD22 (CAR1922T2 T cells) in participants with refractory/relapsed B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma. After treatment with CAR1922T2 T cells, the effectiveness and safety of CAR1922T2 T-cell therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma will be assessed through clinical symptom evaluation, quality of life assessment, biomarker testing, laboratory testing, imaging evaluation, adverse event monitoring, and follow-up surveys.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Biological: CAR1922T2 T cells（Targeting CD19 and CD22 with CAR-T cells）Administer a single infusion of CAR1922T2 T cells to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion, and conduct follow-up surveys at the required time points within three years post-infusion according to the visit schedule. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. The patient or their legal guardian voluntarily participates and signs an informed consent form.
- 2.Age between 18-80 years old (inclusive), with no gender restrictions. 3.Diagnosed with acute B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma according to the WHO 2016 classification.
- 4.CD19 or CD22 positivity confirmed by flow cytometry or histopathology. 5.Diagnosed with refractory/relapsed B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
- 7.Women of childbearing age with negative urine/blood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion; male subjects with reproductive capacity must agree to use effective barrier contraceptive methods for at least 1 year after infusion.
- 8.ECOG score ≤ 1. 9.Life expectancy greater than 3 months.
Key exclusion criteria (10 listed)
- 1.Women who are breastfeeding. 2.Patients with uncontrollable infectious diseases within 4 weeks before enrollment.
- 3.Active hepatitis B/C. 4.HIV-infected patients. 5.Patients with severe autoimmune diseases or immunodeficiency diseases. 6.Patients with allergic constitution, allergic to antibodies or cytokines and other large molecule biological drugs.
- 7.Patients who have participated in other clinical trials within 4 weeks before enrollment.
- 8.History of clinically significant central nervous system diseases: such as epilepsy, paralysis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes.
- 9.Patients with mental illness. 10.Patients with drug abuse/addiction. 11.Use of contraindicated medications.
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 |
|---|---|---|
| CAR1922T2 T cells（Targeting CD19 and CD22 with CAR-T cells）Administer a single infusion of CAR1922T2 T cells to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion | Biological | Experimental Arm |
Primary outcome
ORR
Time frame: 3 years
The overall response rate (ORR) includes both complete response (CR) and partial response (PR), and uses the Clopper-Pearson method to calculate the two-sided 95% confidence interval.
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 6 Jan 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAR1922T2 T cells（Targeting CD19 and CD22 with CAR-T cells） in people with R/R NHL, run by Tongji Hospital.
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 10 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: opening soon, as of the sponsor's last update on 6 Jan 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 Jia Wei, Ph.D. (027-83662680 ext. 13986102084, jiawei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 3 years). 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 6 Jan 2026.