Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL)Phase 1/2CAR-TNCT06911710
The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors
A Phase 1/2 study testing CAR-T Cells infusion（CAR2219,CAR2019, CAR19 etc） in people with Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL) and AML (Acute Myelogenous Leukemia), run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
This study is an open, single-arm, prospective, Phase I/II clinical study using "3+3" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed/refractory malignant hematological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL), AML (Acute Myelogenous Leukemia), Myeloma Multiple
- What is being tested?
- CAR-T Cells infusion（CAR2219,CAR2019, CAR19 etc）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2024to 28 Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With their own consent and have signed an informed consent form, willing and able to comply with the planned visits, study treatment, laboratory tests and other experimental procedures; Patients with recurrent/refractory malignant hematologic tumors as determined by clinical diagnosis; Age 18 years and above, both male and female; Subjects with a physical status of 0~2 on the Eastern Cooperative Oncology Group (ECOG) score; Expected survival >3 months from the date of informed consent; HGB ≥ 60g/L (transfusion is allowed); Liver and kidney function, cardiopulmonary function meet the following requirements: a) creatinine ≤1.5×ULN;b) Left ventricular ejection fraction ≥50%; c) Blood oxygen saturation >90%;d) Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Subjects with pregnancy plans must agree to use contraception prior to enrollment in the study and after the study has lasted for six months; subjects should notify the investigator immediately if they become pregnant or suspect pregnancy.
- Subjects in the different cohorts will still be required to fulfill the following conditions:
- Lymphoma Cohort:
- B-cell lymphoma Diagnosis of CD19+ and/or CD20+ and/or CD22+ and/or BAFF+ B-cell lymphoma confirmed by pathology and histology; Inert B-cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B-cell lymphoma (DLBCL, BL, MCL).
- Meet the following criteria for relapsed or refractory B-cell lymphoma (meet 1 of the first 2 plus 3 below):
- Less than 50% tumor shrinkage or disease progression after 4 courses of standard regimen regulated chemotherapy; relapse after achieving CR after standard regimen chemotherapy; subjects must have received adequate prior therapy, including at least: Anti-CD20 monoclonal antibody; Anthracycline-containing combination chemotherapy. T-cell lymphoma
Show all 21Show fewer
- Diagnosis of CD7+ refractory/relapsed T-lymphocyte lymphoma confirmed by pathology and histology, meeting any of the following criteria:
- Relapsed: Disease relapse determined after having previously received at least two standardized treatment regimens to achieve complete remission, or disease relapse after having undergone stem cell transplantation to achieve complete remission; Refractory: previous treatment with at least two regimens and failure to achieve complete remission after the last treatment, or failure to achieve remission or disease progression after stem cell transplantation.
- II Acute lymphoblastic leukemia cohort:
- Acute B-lymphoblastic leukemia Refractory/relapsed B-lymphoblastic leukemia diagnosed as CD19+ and/or CD20+ and/or CD22+ and/or BAFF+ confirmed by immunohistochemistry or flow cytometry.
- Refractory/relapsed B-lymphoblastic leukemia (meeting 1 of the following 4 criteria is sufficient):
- Relapse within 6 months of first remission; first refractory without achieving complete remission with 2 cycles of standard chemotherapy regimen; failure to achieve complete remission or relapse after first or multiple lines of salvage chemotherapy; those who are not suitable for HSCT, or who have abandoned HSCT due to medical constraints, or those who have relapsed after HSCT.
- Acute T-lymphoblastic leukemia
- Diagnosis of CD7+ refractory/relapsed T-ALL/LBL confirmed by immunohistochemistry or flow cytometry, meeting any of the following criteria:
- No CR after standard chemotherapy; CR after first treatment, but CR lasted less than 12 months; No CR after first or more remedial therapy; Relapse two or more times.
- multiple myeloma cohort:
- Positive expression of BCMA and/or CD19 and/or GPRC5D in myeloma cells by flow or immunohistochemistry; Patients with relapsed/refractory multiple myeloma who have received at least 1 prior therapy (including proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs)) or are resistant to proteasome inhibitors and/or immunomodulatory agents.
- myeloid tumor cohort:
- Positive tumor cell antigen test results (CD7 and/or CD19 and/or CD47) confirmed by immunohistochemistry or flow cytometry; Diagnosis of myeloid tumors, including but not limited to AML and MDS, confirmed by pathology and the patient meets the following
- Relapse or refractory requirements:
- Relapse: reappearance of leukemic cells in the peripheral blood, or >5% of primitive cells found in the bone marrow, or extramedullary relapse after second-line or higher salvage therapy to achieve CR/CRi; Refractory: failure to achieve CR/CRi after at least 2 cycles of standard chemotherapy.
Who cannot join
- a history of severe cardiac insufficiency with a left ventricular ejection fraction <50%; A history of severe lung function-impairing disease; Combination of other malignant tumors in progressive stages; Combination of severe infections that cannot be effectively controlled; Combination of severe autoimmune disease or congenital immunodeficiency; Active hepatitis (Hepatitis B virus deoxyribonucleic acid [HBV-DNA] or Hepatitis C virus ribonucleic acid [HCV-RNA] test results above the lower limit of detection); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; History of severe allergy to biological products (including antibiotics); Allogeneic hematopoietic stem cell transplantation patients who still have acute graft-versus-host reaction (GvHD) one month after stopping immunosuppressive drugs; Presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the results of the study, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.
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
TianJin China. TianJin Medical University General
Tianjin, Tianjin Municipality, 300072
Donglai Jin, +86 22 6036 1044, yhwhao@126.com
About this study
This study is an open, single-arm, prospective, Phase I/II clinical study using "3+3" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed/refractory malignant hematological neoplasms in subjects.
- Conditions
- Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL), AML (Acute Myelogenous Leukemia), Myeloma Multiple, B-ALL, T-ALL/Lymphoma, T-lymphocyte Lymphoma
- Being tested
- CAR-T Cells infusion（CAR2219,CAR2019, CAR19 etc）
- Medical subject headings
- Lymphoma, Leukemia, Myeloid, Acute, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T Cells infusion（CAR2219,CAR2019, CAR19 etc）Drug
Phase I study: dose-escalation component.This part follows the "3+3" dose-escalation model, with 5 dose groups: 1×10^6, 1.5×10^6, 2×10^6, 2.5×10^6, 3×10^6 CAR+ cells/kg (different target CAR-T can be adjusted by the investigator according to the dose used in the previous clinical trial). Each dose group enrolled 3~6 patients with relapsed/refractory hematological diseases respectively, totaling 15~30 subjects, in order to evaluate the safety of CAR-T cells for the treatment of relapsed/refractory malignant hematological neoplasms and to determine the MTD. Phase II study: dose-expansion portion. After the MTD was confirmed, in the dose-expansion portion of the study (Phase II), it was expected that 65~60 subjects would receive the CAR-T cell injection infusion under RP2D to further evaluate the efficacy of CAR-T cell injection.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment group | Experimental | CAR-T Cells infusion（CAR 2219，CAR2019，CAR19 ect） Receives: Drug: CAR-T Cells infusion（CAR2219,CAR2019, CAR19 etc） |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events
Measured: Day 28
Secondary outcomes (5)
Objective response rate (ORR)
Measured: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
Complete response rate (CRR)
Measured: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
Duration of response (DOR)
Measured: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
Progression free survival (PFS)
Measured: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
Overall survival (OS)
Measured: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start9 Nov 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL)Studies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Responsible party
- Principal investigator, Yihao Wang, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911710
- Sponsor's protocol ID
- IRB2022-YX-013-01
- Acronym
- CAR-T
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors
- ClinicalTrials.gov ID
- NCT06911710
- Acronym / sponsor ID
- CAR-T / IRB2022-YX-013-01
- Conditions
- Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL), AML (Acute Myelogenous Leukemia), Myeloma Multiple, B-ALL, T-ALL/Lymphoma, T-lymphocyte Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Study start
- 9 Nov 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 4 Apr 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.
This study is an open, single-arm, prospective, Phase I/II clinical study using "3+3" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed/refractory malignant hematological neoplasms in subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T treatment group | Experimental | Drug: CAR-T Cells infusion（CAR2219,CAR2019, CAR19 etc）CAR-T Cells infusion（CAR 2219，CAR2019，CAR19 ect） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- With their own consent and have signed an informed consent form, willing and able to comply with the planned visits, study treatment, laboratory tests and other experimental procedures; Patients with recurrent/refractory malignant hematologic tumors as determined by clinical diagnosis; Age 18 years and above, both male and female; Subjects with a physical status of 0~2 on the Eastern Cooperative Oncology Group (ECOG) score; Expected survival >3 months from the date of informed consent; HGB ≥ 60g/L (transfusion is allowed); Liver and kidney function, cardiopulmonary function meet the following requirements: a) creatinine ≤1.5×ULN;b) Left ventricular ejection fraction ≥50%; c) Blood oxygen saturation >90%;d) Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Subjects with pregnancy plans must agree to use contraception prior to enrollment in the study and after the study has lasted for six months; subjects should notify the investigator immediately if they become pregnant or suspect pregnancy.
- Subjects in the different cohorts will still be required to fulfill the following conditions:
- B-cell lymphoma Diagnosis of CD19+ and/or CD20+ and/or CD22+ and/or BAFF+ B-cell lymphoma confirmed by pathology and histology; Inert B-cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B-cell lymphoma (DLBCL, BL, MCL).
- Meet the following criteria for relapsed or refractory B-cell lymphoma (meet 1 of the first 2 plus 3 below):
- Less than 50% tumor shrinkage or disease progression after 4 courses of standard regimen regulated chemotherapy; relapse after achieving CR after standard regimen chemotherapy; subjects must have received adequate prior therapy, including at least: Anti-CD20 monoclonal antibody; Anthracycline-containing combination chemotherapy. T-cell lymphoma
Key exclusion criteria (1 listed)
- a history of severe cardiac insufficiency with a left ventricular ejection fraction <50%; A history of severe lung function-impairing disease; Combination of other malignant tumors in progressive stages; Combination of severe infections that cannot be effectively controlled; Combination of severe autoimmune disease or congenital immunodeficiency; Active hepatitis (Hepatitis B virus deoxyribonucleic acid [HBV-DNA] or Hepatitis C virus ribonucleic acid [HCV-RNA] test results above the lower limit of detection); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; History of severe allergy to biological products (including antibiotics); Allogeneic hematopoietic stem cell transplantation patients who still have acute graft-versus-host reaction (GvHD) one month after stopping immunosuppressive drugs; Presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the results of the study, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.
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 Cells infusion（CAR2219,CAR2019, CAR19 etc）Phase I study: dose-escalation component.This part follows the "3+3" dose-escalation model, with 5 dose groups: 1×10^6, 1.5×10^6, 2×10^6, 2.5×10^6, 3×10^6 CAR+ cells/kg (different target CAR-T can be adjusted by the investigator according to the dose used in the previous clinical trial). Each dose group enrolled 3~6 patients with relapsed/refractory hematological diseases respectively, totaling 15~30 subjects, in order to evaluate the safety of CAR-T cells for the treatment of relapsed/refractory malignant hematological neoplasms and to determine the MTD. Phase II study: dose-expansion portion. After the MTD was confirmed, in the dose-expansion portion of the study (Phase II), it was expected that 65~60 subjects would receive the CAR-T cell injection infusion under RP2D to further evaluate the efficacy of CAR-T cell injection. | Drug | CAR-T treatment group |
Primary outcome
The incidence of adverse events
Time frame: Day 28
5 secondary outcomes
Objective response rate (ORR)
Time frame: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
Complete response rate (CRR)
Time frame: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
Duration of response (DOR)
Time frame: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
Progression free survival (PFS)
Time frame: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
Overall survival (OS)
Time frame: At 3, 6, 9, 12, 18, and 24 months post-treatment follow up
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 4 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CAR-T Cells infusion（CAR2219,CAR2019, CAR19 etc） in people with Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL) and AML (Acute Myelogenous Leukemia), run by Tianjin Medical University General 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 21 inclusion and 1 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 4 Apr 2025. 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 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 Rong Fu (+86 12260817111, yhwhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (time frame: Day 28). 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 4 Apr 2025.