Large B-Cell Lymphoma (LBCL)Phase 1/2NCT07447726
Exploratory Clinical Study on the Safety and Efficacy of CD19X CAR-T Cell Injection in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma
A Phase 1/2 study testing CD19X CAR-T in people with Large B-Cell Lymphoma (LBCL), run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study is an open-label, single-arm, prospective, exploratory clinical trial involving patients with relapsed/refractory large B-cell lymphoma, aiming to preliminarily assess the safety and efficacy of CAR-T cell infusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Large B-Cell Lymphoma (LBCL)
- What is being tested?
- CD19X CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2026to 1 Jan 2028
- Phase
- Phase 1/2
- 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 participant has given consent and signed the informed consent form, and is willing and able to comply with planned visits, research treatments, laboratory tests, and other trial procedures;
- 2. Clinically diagnosed with relapsed/refractory large B-cell lymphoma, and confirmed by pathology or flow cytometry that tumor cells express CD19, including: diffuse large B-cell lymphoma (DLBCL), transformed indolent B-cell lymphoma to DLBCL (excluding Richter transformation), and meeting the following criteria (satisfying one of the first two and the third): i. Relapse ≥6 months after achieving remission following first-line adequate therapy or ≥12 months after stem cell transplantation; ii. Patients who did not achieve remission after at least 2-4 cycles of first-line chemotherapy combined with high-risk factors (double-expressor lymphoma, double-hit lymphoma, TP53 gene mutation or deletion, IPI score ≥3), or disease progression during first-line therapy, or progression within 6 months after achieving remission from prior sufficient therapy, or relapse within 12 months after achieving remission from stem cell transplantation; iii. The participant has received the following treatments for LBCL after diagnosis:
- Anti-CD20 monoclonal antibody;
- Combination chemotherapy containing anthracyclines.
- 3. Age 18 years and above, both male and female;
- 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
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- 5. Expected survival of more than 3 months from the date of signing the informed consent form;
- 6. HGB ≥ 60 g/L (blood transfusion allowed); LYM ≥ 0.3*10^9/L;
- 7. Liver and kidney function, as well as cardiopulmonary function, must meet the following requirements:
- Creatinine ≤ 1.5×ULN;
- Left ventricular ejection fraction ≥ 50%;
- Blood oxygen saturation > 90%;
- Total bilirubin ≤ 1.5×ULN; ALT and AST ≤ 2.5×ULN;
- 8. Study participants planning pregnancy must agree to use contraception before enrollment in the study and for one year after CAR-T cell infusion; participants should notify the investigator immediately if they become pregnant or suspect they are pregnant.
Who cannot join
- 1. Severe heart failure with left ventricular ejection fraction <50%;
- 2. History of severe pulmonary dysfunction;
- 3. Concurrent progressive malignant tumors;
- 4. Severe infections that cannot be effectively controlled;
- 5. Severe autoimmune diseases or congenital immunodeficiency;
- 6. History of CAR-T cell immunotherapy;
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- 7. Active hepatitis (hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] levels above the detection limit);
- 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- 9. History of severe allergic reactions to biological products (including antibiotics);
- 10. Allogeneic hematopoietic stem cell transplant patients who still have acute graft-versus-host disease (GvHD) one month after discontinuing immunosuppressive drugs.
- 11. Women who are pregnant or breastfeeding, or planning to become pregnant within 12 months;
- 12. Individuals with other serious physical or mental illnesses or abnormal laboratory test results that may increase the risk of participating in the study, interfere with the study results, or whom the researcher considers unsuitable for participation in this study.
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
This study is an open-label, single-arm, prospective, exploratory clinical trial involving patients with relapsed/refractory large B-cell lymphoma, aiming to preliminarily assess the safety and efficacy of CAR-T cell infusion.
Read the detailed description
This study is an open-label, single-arm, prospective, exploratory clinical trial targeting patients with relapsed/refractory large B-cell lymphoma. It plans to enroll 3 participants, where the investigator will administer a dose of 1-2×10^6 CAR cells/kg of CAR-T cell infusion and follow up to observe related data on post-treatment adverse reactions and therapeutic effects, with the aim of preliminarily evaluating the safety and efficacy of the CAR-T cell infusion.
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Being tested
- CD19X CAR-T
- Keywords
- relapsed/refractory
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19X CAR-TDrug
Eligible participants receive lymphodepletion pretreatment 3 to 5 days before the therapy. The recommended pretreatment regimen is fludarabine (25-30 mg/m²) and cyclophosphamide (250-300 mg/m²). Antihistamines are administered before infusion. The plan is to enroll 3 patients with relapsed/refractory large B-cell lymphoma, who will be evaluated by the investigator and treated with 1-2 × 10^6 CAR cells/kg of CAR-T cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| CD19X CAR-T | Other | Not described Receives: Drug: CD19X CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Evaluate the possible adverse reactions recorded after CAR-T infusion, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, and hematologic toxicities.
Measured: Within 28 days after CAR-T infusion
Secondary outcomes (6)
Efficacy indicators
Objective Response Rate (ORR) of tumors
Measured: At 1 and 3 months after CAR-T infusion
Efficacy indicators
Complete Remission (CR) Rate
Measured: At 1 and 3 months after CAR-T infusion
Cell Metabolic Kinetics Indicators
The maximum concentration (Cmax) of the study participants' CAR-T cells in peripheral blood
Measured: On the 7th, 10th, 14th, and 28th days after treatment
Cellular Metabolic Kinetics Indicators
Time (Tmax) at which the study participants' CAR-T cells reach the maximum concentration in peripheral blood
Measured: On the 7th, 10th, 14th, and 28th days after treatment
Cellular Metabolic Kinetics Indicators
Area under the curve (AUC28d) of peripheral blood CAR copy numbers in study participants on day 28.
Measured: Day 28 after treatment
Exploratory indicators
CD19X CAR-T cell infusion products and the in vivo CAR-T single-cell phenotypes, clonal characteristics of study participants, as well as other indicators of interest to researchers, such as cytokine profiles.
Measured: The CAR-T single-cell phenotype and clonal characteristics are tested on the day of cell infusion. Follow-up is conducted on D10 and D28 after infusion, once a month from M2 to M3, every three months from M6 to Y1, and every three months from Y1 to Y2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start5 Apr 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-Cell Lymphoma (LBCL)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447726
- Sponsor's protocol ID
- IIT2025136
- Status last verified
- Feb 2026
- First submitted
- 23 Dec 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study on the Safety and Efficacy of CD19X CAR-T Cell Injection in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07447726
- Acronym / sponsor ID
- IIT2025136
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Keywords
- relapsed/refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 3 Mar 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 study is an open-label, single-arm, prospective, exploratory clinical trial involving patients with relapsed/refractory large B-cell lymphoma, aiming to preliminarily assess the safety and efficacy of CAR-T cell infusion.
Detailed description
This study is an open-label, single-arm, prospective, exploratory clinical trial targeting patients with relapsed/refractory large B-cell lymphoma. It plans to enroll 3 participants, where the investigator will administer a dose of 1-2×10^6 CAR cells/kg of CAR-T cell infusion and follow up to observe related data on post-treatment adverse reactions and therapeutic effects, with the aim of preliminarily evaluating the safety and efficacy of the CAR-T cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19X CAR-T | Other | Drug: CD19X CAR-T |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. The participant has given consent and signed the informed consent form, and is willing and able to comply with planned visits, research treatments, laboratory tests, and other trial procedures;
- 2. Clinically diagnosed with relapsed/refractory large B-cell lymphoma, and confirmed by pathology or flow cytometry that tumor cells express CD19, including: diffuse large B-cell lymphoma (DLBCL), transformed indolent B-cell lymphoma to DLBCL (excluding Richter transformation), and meeting the following criteria (satisfying one of the first two and the third): i. Relapse ≥6 months after achieving remission following first-line adequate therapy or ≥12 months after stem cell transplantation; ii. Patients who did not achieve remission after at least 2-4 cycles of first-line chemotherapy combined with high-risk factors (double-expressor lymphoma, double-hit lymphoma, TP53 gene mutation or deletion, IPI score ≥3), or disease progression during first-line therapy, or progression within 6 months after achieving remission from prior sufficient therapy, or relapse within 12 months after achieving remission from stem cell transplantation; iii. The participant has received the following treatments for LBCL after diagnosis:
- 3. Age 18 years and above, both male and female;
- 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- 5. Expected survival of more than 3 months from the date of signing the informed consent form;
Key exclusion criteria (12 listed)
- 1. Severe heart failure with left ventricular ejection fraction <50%;
- 2. History of severe pulmonary dysfunction;
- 3. Concurrent progressive malignant tumors;
- 4. Severe infections that cannot be effectively controlled;
- 5. Severe autoimmune diseases or congenital immunodeficiency;
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 |
|---|---|---|
| CD19X CAR-TEligible participants receive lymphodepletion pretreatment 3 to 5 days before the therapy. The recommended pretreatment regimen is fludarabine (25-30 mg/m²) and cyclophosphamide (250-300 mg/m²). Antihistamines are administered before infusion. The plan is to enroll 3 patients with relapsed/refractory large B-cell lymphoma, who will be evaluated by the investigator and treated with 1-2 × 10^6 CAR cells/kg of CAR-T cell infusion. | Drug | CD19X CAR-T |
Primary outcome
Incidence and severity of adverse events
Time frame: Within 28 days after CAR-T infusion
Evaluate the possible adverse reactions recorded after CAR-T infusion, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, and hematologic toxicities.
6 secondary outcomes
Efficacy indicators
Time frame: At 1 and 3 months after CAR-T infusion
Efficacy indicators
Time frame: At 1 and 3 months after CAR-T infusion
Cell Metabolic Kinetics Indicators
Time frame: On the 7th, 10th, 14th, and 28th days after treatment
Cellular Metabolic Kinetics Indicators
Time frame: On the 7th, 10th, 14th, and 28th days after treatment
Cellular Metabolic Kinetics Indicators
Time frame: Day 28 after treatment
Exploratory indicators
Time frame: The CAR-T single-cell phenotype and clonal characteristics are tested on the day of cell infusion. Follow-up is conducted on D10 and D28 after infusion, once a month from M2 to M3, every three months from M6 to Y1, and every three months from Y1 to Y2.
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 3 Mar 2026.
- Individual participant dataSharing planned: Yes
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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 Phase 1/2 study testing CD19X CAR-T in people with Large B-Cell Lymphoma (LBCL), run by Institute of Hematology & Blood Diseases Hospital, 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 14 inclusion and 12 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 3 Mar 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Liang Huang (02223608359, huangliang@ihcams.ac.cn), 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: Within 28 days after CAR-T infusion). 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 3 Mar 2026.