Relapsed/Refractory B-cell LymphomaPhase 1NCT07539688
Phase I Clinical Study on the Safety and Efficacy of CY-219 CAR-T Cell Injection in the Treatment of Relapsed/Refractory B-Cell Lymphoma
A Phase 1 study testing CY-219 CAR-T in people with Relapsed/Refractory B-cell Lymphoma and Diffuse Large B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study is an open-label, single-arm, prospective clinical trial involving patients with relapsed/refractory B-cell lymphoma, aimed at evaluating 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
- Relapsed/Refractory B-cell Lymphoma, Diffuse Large B-cell Lymphoma, Inert B-cell Lymphoma Transformed Into Large B-cell Lymphoma (Excluding Richter Transformation, THRLBCL, and BL)
- What is being tested?
- CY-219 CAR-T
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Dec 2029
- Phase
- 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
- 1. The participant has given consent and signed the informed consent form, and is willing and able to comply with the planned visits, research treatments, laboratory tests, and other trial procedures;
- 2. Clinically diagnosed as a patient with relapsed/refractory B-cell lymphoma, and confirmed by pathological and histological examination as CD19 and/or CD22 B-cell lymphoma, including: diffuse large B-cell lymphoma, or transformed large B-cell lymphoma from indolent B-cell lymphoma (excluding Richter transformation, THRLBCL, BL). And meets the following criteria (meets any one of the first three items and the fourth): i. Recurrence ≥6 months after achieving remission with first-line full treatment, or ≥12 months after achieving remission following stem cell transplantation; ii. Progression during first-line treatment combined with high-risk factors (double-expressor lymphoma, double-hit lymphoma, TP53 gene mutation or deletion, IPI score ≥3); iii. Disease relapse after ≥2 lines of treatment or failure to achieve remission; iv. The participant has received the following treatment regimens after being diagnosed with LBCL:
- Anti-CD20 monoclonal antibody;
- Combination chemotherapy containing anthracyclines.
- 3. Age 18 or older, both men and women are eligible;
- 4. Study participants with an 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;
- 6. HGB ≥ 60 g/L (transfusion allowed); LYM ≥ 0.3×10^9/L;
- 7. Liver and kidney function and 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. Participants intending to become pregnant must agree to use contraception before enrollment in the study and for one year after CAR-T cell infusion; if a participant becomes pregnant or suspects pregnancy, they should immediately inform the investigator.
Who cannot join
- 1. Severe heart failure or left ventricular ejection fraction <50%;
- 2. History of severe pulmonary function impairment;
- 3. Concurrent other malignant tumors in the progressive stage;
- 4. Concurrent severe infection that cannot be effectively controlled;
- 5. Concurrent severe autoimmune disease or congenital immunodeficiency;
- 6. History of CAR-T cell immunotherapy;
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- 7. Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA] or hepatitis C virus ribonucleic acid [HCV-RNA] test results above the detection limit);
- 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
- 9. A 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 stopping immunosuppressive agents;
- 11. Women who are pregnant, breastfeeding, or planning to become pregnant within 12 months;
- 12. Patients with other serious physical or mental illnesses or abnormal laboratory test results that may increase the risk of participating in the study, or interfere with study results, or who are deemed by the investigators to be 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 clinical trial involving patients with relapsed/refractory B-cell lymphoma, aimed at evaluating the safety and efficacy of CAR-T cell infusion.
Read the detailed description
This study is an open-label, single-arm, prospective clinical trial involving patients with relapsed/refractory B-cell lymphoma. It plans to enroll 9-18 participants and uses a "3+3" dose-escalation design (with 3 dose groups: 1×10^6, 2×10^6, and 3×10^6 CAR cells/kg) along with a dose-expansion study to administer CAR-T cell injection. Patients will be followed to observe adverse reactions and collect data on treatment efficacy, evaluating the safety and effectiveness of the CAR-T cell injection. The DLT observation period is 28 days after CAR-T cell infusion.
- Conditions
- Relapsed/Refractory B-cell Lymphoma, Diffuse Large B-cell Lymphoma, Inert B-cell Lymphoma Transformed Into Large B-cell Lymphoma (Excluding Richter Transformation, THRLBCL, and BL)
- Being tested
- CY-219 CAR-T
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CY-219 CAR-TDrug
Eligible participants should receive preconditioning 5 to 3 days before CAR-T cell infusion. The recommended preconditioning regimen is fludarabine (30 mg/m²/day, for 3 consecutive days) and cyclophosphamide (300 mg/m²/day, for 3 consecutive days) (Flu/Cy). Thirty minutes before infusion, prophylactic medication for allergic reactions should be administered: 25 mg of promethazine hydrochloride or 12.5 mg of diphenhydramine, either intramuscularly or orally. A '3+3' dose-escalation study design will be used, aiming to recruit 9-18 subjects with relapsed/refractory B-cell lymphoma.
| Study group | Role | What they receive |
|---|---|---|
| CY-219 CAR-T | Other | Not described Receives: Drug: CY-219 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety indicators
Six months after CAR-T infusion, analyze the recorded possible adverse reactions, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, hematologic toxicity, and organ toxicity. The incidence of DLT.
Measured: 6 months after CAR-T infusion
Secondary outcomes (7)
Efficacy indicators
Tumor objective response rate (ORR) at 3 months follow-up after treatment.
Measured: Three months after treatment
Efficacy indicators
Complete remission (CR) rate at 3 months post-treatment follow-up
Measured: Three months after treatment
Efficacy indicators
Overall survival (OS) at 3 months post-treatment follow-up
Measured: Three months after treatment
Efficacy indicators
Progression-free survival (PFS) at 3 months after treatment follow-up
Measured: Three months after treatment
Cellular Metabolic Kinetics Indicators
Peripheral blood CAR copy number of research participants during follow-up
Measured: On the fourth, seventh, tenth, fourteenth, twenty-first, and twenty-eighth days after retransfusion
Cellular Metabolic Kinetics Indicators
Maximum concentration (Cmax) of CAR-T cells in peripheral blood and the time to reach it
Measured: Peripheral blood CAR copy number of research participants during follow-up
Cellular Metabolic Kinetics Indicators
Area under the CAR-T expansion curve AUC0-28d over 28 days
Measured: 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Dec 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539688
- Sponsor's protocol ID
- IIT2025149
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on the Safety and Efficacy of CY-219 CAR-T Cell Injection in the Treatment of Relapsed/Refractory B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07539688
- Acronym / sponsor ID
- IIT2025149
- Conditions
- Relapsed/Refractory B-cell Lymphoma, Diffuse Large B-cell Lymphoma, Inert B-cell Lymphoma Transformed Into Large B-cell Lymphoma (Excluding Richter Transformation, THRLBCL, and BL)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 20 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 study is an open-label, single-arm, prospective clinical trial involving patients with relapsed/refractory B-cell lymphoma, aimed at evaluating the safety and efficacy of CAR-T cell infusion.
Detailed description
This study is an open-label, single-arm, prospective clinical trial involving patients with relapsed/refractory B-cell lymphoma. It plans to enroll 9-18 participants and uses a "3+3" dose-escalation design (with 3 dose groups: 1×10^6, 2×10^6, and 3×10^6 CAR cells/kg) along with a dose-expansion study to administer CAR-T cell injection. Patients will be followed to observe adverse reactions and collect data on treatment efficacy, evaluating the safety and effectiveness of the CAR-T cell injection. The DLT observation period is 28 days after 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 |
|---|---|---|
| CY-219 CAR-T | Other | Drug: CY-219 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 the planned visits, research treatments, laboratory tests, and other trial procedures;
- 2. Clinically diagnosed as a patient with relapsed/refractory B-cell lymphoma, and confirmed by pathological and histological examination as CD19 and/or CD22 B-cell lymphoma, including: diffuse large B-cell lymphoma, or transformed large B-cell lymphoma from indolent B-cell lymphoma (excluding Richter transformation, THRLBCL, BL). And meets the following criteria (meets any one of the first three items and the fourth): i. Recurrence ≥6 months after achieving remission with first-line full treatment, or ≥12 months after achieving remission following stem cell transplantation; ii. Progression during first-line treatment combined with high-risk factors (double-expressor lymphoma, double-hit lymphoma, TP53 gene mutation or deletion, IPI score ≥3); iii. Disease relapse after ≥2 lines of treatment or failure to achieve remission; iv. The participant has received the following treatment regimens after being diagnosed with LBCL:
- 3. Age 18 or older, both men and women are eligible;
- 4. Study participants with an 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;
Key exclusion criteria (12 listed)
- 1. Severe heart failure or left ventricular ejection fraction <50%;
- 2. History of severe pulmonary function impairment;
- 3. Concurrent other malignant tumors in the progressive stage;
- 4. Concurrent severe infection that cannot be effectively controlled;
- 5. Concurrent severe autoimmune disease 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 |
|---|---|---|
| CY-219 CAR-TEligible participants should receive preconditioning 5 to 3 days before CAR-T cell infusion. The recommended preconditioning regimen is fludarabine (30 mg/m²/day, for 3 consecutive days) and cyclophosphamide (300 mg/m²/day, for 3 consecutive days) (Flu/Cy). Thirty minutes before infusion, prophylactic medication for allergic reactions should be administered: 25 mg of promethazine hydrochloride or 12.5 mg of diphenhydramine, either intramuscularly or orally. A '3+3' dose-escalation study design will be used, aiming to recruit 9-18 subjects with relapsed/refractory B-cell lymphoma. | Drug | CY-219 CAR-T |
Primary outcome
Safety indicators
Time frame: 6 months after CAR-T infusion
Six months after CAR-T infusion, analyze the recorded possible adverse reactions, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, hematologic toxicity, and organ toxicity. The incidence of DLT.
7 secondary outcomes
Efficacy indicators
Time frame: Three months after treatment
Efficacy indicators
Time frame: Three months after treatment
Efficacy indicators
Time frame: Three months after treatment
Efficacy indicators
Time frame: Three months after treatment
Cellular Metabolic Kinetics Indicators
Time frame: On the fourth, seventh, tenth, fourteenth, twenty-first, and twenty-eighth days after retransfusion
Cellular Metabolic Kinetics Indicators
Time frame: Peripheral blood CAR copy number of research participants during follow-up
Cellular Metabolic Kinetics Indicators
Time frame: 28 days after treatment
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 20 Apr 2026.
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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 study testing CY-219 CAR-T in people with Relapsed/Refractory B-cell Lymphoma and Diffuse Large B-cell Lymphoma, 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 20 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?
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.
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?
Safety indicators (time frame: 6 months 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 20 Apr 2026.