Multiple MyelomaPhase 1NCT06758713

Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies

A Phase 1 study testing CAR-T in people with Multiple Myeloma and B-cell Lymphoma, run by The Third Affiliated Hospital of Southern Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a single center, open-label, dose-escalation/expansion clinical study to evaluate the safety and effectiveness of Fourth-Generation CAR-T, and determine the recommended dose of the CAR T-cells for patients with Multiple Myeloma，B-cell lymphoma and other hematologic malignancies. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Multiple Myeloma, B-cell Lymphoma, Hematological Malignancy
What is being tested?: CAR-T
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 15 Jan 2025to 31 Dec 2028
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

Subjects must meet all of the following criteria to be enrolled:
1. Voluntarily participate in this clinical study and sign the informed consent form; 2. 18 to 75 years old (including cut-off value), Male and female;; 3. Expected survival of at least 3 months; 4.1 CD19-positive B lymphocyte-derived hematologic malignancies; 4.2 Multiple myeloma patients; 4.3 Non-B cell-derived hematologic malignancies patients with CD7 or other target molecules; 5. The clinical trial values during the screening period meet the following criteria:
White blood cell count ≥ 3.0 × 10e9/L; Absolute neutrophil ≥ 1.0 × 10e9/L; Lymphocyte count ≥ 0.5 × 10e9/L. (The growth factor support is allowed, but growth factor must not have been received within 7 days prior to laboratory testing);
Platelet count ≥ 50 × 10e9/L (No blood transfusion support within 7 days prior to laboratory tests.); Note: Patients with leukemia, multiple myeloma, and lymphoma are not subject to the above blood picture requirements;
Biochemical indicators Serum total bilirubin (TBIL) ≤ 2.5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN, or 5 ULN if liver dysfunction is primarily due to tumor invasion); 6. Cardiac function: Subjects must have good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 55%; 7. Lung condition: Subjects are not serious infections such as severe pneumonia; 8. ECOG activity status score: 0-2 points; 9. Female subjects must use effective contraception (such as oral prescription contraceptives, injectable contraceptives, intrauterine devices, double blockade, contraceptive patches, male partner sterilization) throughout the study period; Must have a negative serum or urine pregnancy test result at screening and throughout the study.

Who cannot join

Any one of the following conditions cannot be selected as a subject:
Having received CAR-T therapy targeting the same molecule;
Having received other immunotargeted therapy targeting the same molecules;
Pregnant or lactating women;
Subjects who have previously suffered from other malignancies, with the following exceptions:
Having received curative therapy, and no known active disease in the ≥ 3 years prior to the enrollment;

Show all 19Show fewer

Non melanoma skin cancer subjects who have completed sufficient treatment and no evidence of thecurrent disease;
Subjects with a severe mental disorder;
Subjects with active autoimmune disease requiring immunotherapy;
Having received allogeneic hematopoietic stem cell transplantation;
Subjects with significant cardiovascular diseasesa.uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart disease with cardiac function grade 3 or grade 4 (according to the functional classification method of the New York Heart Association NYHA); b. Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening); c. Clinically significant history of ventricular arrhythmia or unexplained syncope (non vaso-vagal or not due to dehydration);
Subjects with active infectious disease including positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood Hepatitis B virus(HBV) DNA titer is ≥500IU/mL, hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive, human immunodeficiency virus(HIV) antibody positive, syphilis primary screening antibody positive, active pulmonary tuberculosis; or with any significant infection requiring high-grade antibiotics Event;
Subjects with dysfunction of important organssuch as organ function in the following abnormalities:
Serum AST or ALT > 2.5×ULN, or > 5ULN if liver function is predominantly due to tumor invasion; TBIL > 2.5 × ULN, unless the subject is Gilbert's syndrome;
Serum creatinine>2.5mg/dl;
Partial prothrombin time or activated partial thromboplastin time or international normalized ratio > 1.5×ULN in the absence of anticoagulant therapy;
Participation in other clinical studies or prior treatment with any gene therapy product in the past three months;
Subjects with uncontrolled diabetes mellitus (glycosylated hemoglobin HbAlc >8% at screening);13. Highly allergic constitution or history of severe allergies, and having contraindications to cyclophosphamide or fludarabine;
14. Feasibility assessment screening demonstrated <10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation (<5-fold); 15. Subjects who are considered unsuitable to participate in this trial by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yan Yi, MD. contact

+86 13617493781

yiyan@smu.edu.cn

China1 site, 1 recruiting

The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510630
Yan Yi, MD., +86 13617493781, yiyan@smu.edu.cn
Recruiting

Other trials in China

About this study

Read the detailed description

This is a single center, open-label, dose-escalation/expansion clinical study to evaluate the safety and efficacy of Fourth-Generation CAR-T in the Treatment of Multiple Myeloma，B-cell lymphoma and other hematologic malignancies.. -Prior to Fourth-Generation CAR-T cells infusion, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and RP2D were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials. Meanwhile, subjects will be followed for side effects and effect of the CAR-T.

Conditions: Multiple Myeloma, B-cell Lymphoma, Hematological Malignancy
Being tested: CAR-T
Keywords: Multiple myeloma, B-cell lymphoma, Hematological malignancy, CAR-T, Safety, Efficacy
Medical subject headings: Multiple Myeloma, Lymphoma, B-Cell, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CAR-TBiological
CAR T-cell therapy involves autologous chimeric antigen receptor T-cells, capable of targeting human B cell maturation antigen (BCMA) ,CD19 or CD-7 etc. target molecules of other hematologic malignancies.

Study groups in NCT06758713
Study group	Role	What they receive
Phase 1:Low dose group	Experimental	Infusion of CAR T-cells by single dose of 0.5×10^6 CAR-T cells/kg Receives: Biological: CAR-T
Phase 1: Medium dose group	Experimental	Infusion of CAR T-cells by single dose of 1.5×10^6 CAR-T cells/kg Receives: Biological: CAR-T
Phase 1: High dose group	Experimental	Infusion of CAR T-cells by single dose of 5.0×10^6 CAR-T cells/kg Receives: Biological: CAR-T
Phase 2a: RP2D	Experimental	After all subjects in the Phase 1 dose-escalation study completed DLT observation, RP2D was determined based on the analysis results for the phase 2a expansion study. Receives: Biological: CAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with dose-limiting toxicity (DLT)
For DLT evaluation, severity (grade) is classified according to common terminology criteria for adverse events version 4.03 (CTCAE v4.03).
Measured: Within 30 days of receiving CAR T-cells transfusion therapy
Maximum Tolerated Dose (MTD)
At least 6 subjects in the MTD dose group must complete the DLT assessment.
Measured: Within 30 days of receiving CAR T-cells transfusion therapy
Adverse Event
Safety will be assessed by adverse events (AEs), which include clinically significant abnormalities identified during medical tests (e.g. laboratory tests, electrocardiogram, imaging examinations or physical examinations). AEs will be coded by Medical Dictionary for Regulatory Activities (MeDRA) and their severity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).
Measured: Minimum 2 years after CAR T-cells infusion (Day 1)
Recommended Phase 2 Dose (RP2D)
To determine after all subjects in the Phase 1 dose-escalation study completed DLT observation
Measured: Through study completion, an average of 1 year
Objective response rate (ORR)
The definition of ORR is the proportion of subjects achieving sCR, CR, VGPR, or PR confirmed by efficacy reassessment after a minimum interval of three months. ORR is calculated as (sCR+CR+VGPR+PR) divided by the total number of cases of Multiple Myeloma, or (CR+PR) divided by the total number of cases of B-cell lymphoma and other hematologic malignancies, multiplied by 100%.
Measured: Through study completion, an average of 2 years

Secondary outcomes (3)

Stringent complete response rate (sCRR)
The definition of sCRR is the proportion of subjects achieving sCR confirmed by efficacy re-assessment after a minimum interval of three months. Efficacy assessment for multiple myeloma only.
Measured: Through study completion, an average of 2 years
Progression-free Survival (PFS)
The time interval from the first administration of the investigational drug to the first observation of disease progression is calculated, considering the date of entry for patients who died for reasons other than disease progression before progression occurred.
Measured: Through study completion, an average of 2 years
Overall Survival (OS)
OS is the time from the start of cell infusion to the death of the subject.
Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202531 Dec 2028

First posted6 Jan 2025
Study start15 Jan 2025 (estimated)
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies 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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06758713
Sponsor's protocol ID: 2024-Lunli-020
Other IDs: 2024-Lunli-020
Status last verified: Jul 2024
First submitted: 27 Dec 2024
Last updated: 6 Jan 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Roddie C, Dias J, O'Reilly MA, Abbasian M, Cadinanos-Garai A, Vispute K, Bosshard-Carter L, Mitsikakou M, Mehra V, Roddy H, Hartley JA, Spanswick V, Lowe H, Popova B, Clifton-Hadley L, Wheeler G, Olejnik J, Bloor A, Irvine D, Wood L, Marzolini MAV, Domning S, Farzaneh F, Lowdell MW, Linch DC, Pule MA, Peggs KS. Durable Responses and Low Toxicity After Fast Off-Rate CD19 Chimeric Antigen Receptor-T Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. J Clin Oncol. 2021 Oct 20;39(30):3352-3363. doi: 10.1200/JCO.21.00917. Epub 2021 Aug 31.
PubMed 34464155
Sang W, Wang X, Geng H, Li T, Li D, Zhang B, Zhou Y, Song X, Sun C, Yan D, Li D, Li Z, Li C, Xu K. Anti-PD-1 Therapy Enhances the Efficacy of CD30-Directed Chimeric Antigen Receptor T Cell Therapy in Patients With Relapsed/Refractory CD30+ Lymphoma. Front Immunol. 2022 Apr 1;13:858021. doi: 10.3389/fimmu.2022.858021. eCollection 2022.
PubMed 35432352
Du J, Wei R, Jiang S, Jiang H, Li L, Qiang W, He H, Shi L, Ma Q, Yu K, Zhang X, Ding H, Sun X, Xiang F, Zhu L, Cheng Z, Fu W. CAR-T cell therapy targeting B cell maturation antigen is effective for relapsed/refractory multiple myeloma, including cases with poor performance status. Am J Hematol. 2022 Jul;97(7):933-941. doi: 10.1002/ajh.26583. Epub 2022 May 5.
PubMed 35488407
Yang J, He J, Zhang X, Li J, Wang Z, Zhang Y, Qiu L, Wu Q, Sun Z, Ye X, Yin W, Cao W, Shen L, Sersch M, Lu P. Next-day manufacture of a novel anti-CD19 CAR-T therapy for B-cell acute lymphoblastic leukemia: first-in-human clinical study. Blood Cancer J. 2022 Jul 7;12(7):104. doi: 10.1038/s41408-022-00694-6.
PubMed 35798714
Qu C, Zou R, Wang P, Zhu Q, Kang L, Ping N, Xia F, Liu H, Kong D, Yu L, Wu D, Jin Z. Decitabine-primed tandem CD19/CD22 CAR-T therapy in relapsed/refractory diffuse large B-cell lymphoma patients. Front Immunol. 2022 Aug 17;13:969660. doi: 10.3389/fimmu.2022.969660. eCollection 2022.
PubMed 36059523
Ying Z, Xie Y, Zheng W, Liu W, Lin N, Tu M, Wang X, Ping L, Deng L, Zhang C, Wu M, Feng F, Du T, Tang Y, Su F, Guo Z, Li J, Song Y, Zhu J. Efficacy and safety of relmacabtagene autoleucel, an anti-CD19 chimeric antigen receptor T cell, in relapsed/refractory B-cell non-Hodgkin's lymphoma: 2-year results of a phase 1 trial. Bone Marrow Transplant. 2023 Mar;58(3):288-294. doi: 10.1038/s41409-022-01888-z. Epub 2022 Dec 7.
PubMed 36477110
Liang EC, Albittar A, Huang JJ, Hirayama AV, Kimble EL, Portuguese AJ, Chapuis A, Shadman M, Till BG, Cassaday RD, Milano F, Kiem HP, Riddell SR, Turtle CJ, Maloney DG, Gauthier J. Factors associated with long-term outcomes of CD19 CAR T-cell therapy for relapsed/refractory CLL. Blood Adv. 2023 Nov 28;7(22):6990-7005. doi: 10.1182/bloodadvances.2023011399.
PubMed 37774014
Minson A, Hamad N, Cheah CY, Tam C, Blombery P, Westerman D, Ritchie D, Morgan H, Holzwart N, Lade S, Anderson MA, Khot A, Seymour JF, Robertson M, Caldwell I, Ryland G, Saghebi J, Sabahi Z, Xie J, Koldej R, Dickinson M. CAR T cells and time-limited ibrutinib as treatment for relapsed/refractory mantle cell lymphoma: the phase 2 TARMAC study. Blood. 2024 Feb 22;143(8):673-684. doi: 10.1182/blood.2023021306.
PubMed 37883795

Interested in taking part?

Yan Yi, MD.

+86 13617493781

yiyan@smu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Active, not recruitingPhase 3
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies
ClinicalTrials.gov ID: NCT06758713
Acronym / sponsor ID: 2024-Lunli-020
Conditions: Multiple Myeloma, B-cell Lymphoma, Hematological Malignancy
Keywords: Multiple myeloma, B-cell lymphoma, Hematological malignancy, CAR-T, Safety, Efficacy
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: The Third Affiliated Hospital of Southern Medical UniversityOther government
Study start: 15 Jan 2025 (estimated)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 6 Jan 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase 1:Low dose group	Experimental	Biological: CAR-TInfusion of CAR T-cells by single dose of 0.5×10^6 CAR-T cells/kg
Phase 1: Medium dose group	Experimental	Biological: CAR-TInfusion of CAR T-cells by single dose of 1.5×10^6 CAR-T cells/kg
Phase 1: High dose group	Experimental	Biological: CAR-TInfusion of CAR T-cells by single dose of 5.0×10^6 CAR-T cells/kg
Phase 2a: RP2D	Experimental	Biological: CAR-TAfter all subjects in the Phase 1 dose-escalation study completed DLT observation, RP2D was determined based on the analysis results for the phase 2a expansion study.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

1. Voluntarily participate in this clinical study and sign the informed consent form; 2. 18 to 75 years old (including cut-off value), Male and female;; 3. Expected survival of at least 3 months; 4.1 CD19-positive B lymphocyte-derived hematologic malignancies; 4.2 Multiple myeloma patients; 4.3 Non-B cell-derived hematologic malignancies patients with CD7 or other target molecules; 5. The clinical trial values during the screening period meet the following criteria:
White blood cell count ≥ 3.0 × 10e9/L; Absolute neutrophil ≥ 1.0 × 10e9/L; Lymphocyte count ≥ 0.5 × 10e9/L. (The growth factor support is allowed, but growth factor must not have been received within 7 days prior to laboratory testing);
Platelet count ≥ 50 × 10e9/L (No blood transfusion support within 7 days prior to laboratory tests.); Note: Patients with leukemia, multiple myeloma, and lymphoma are not subject to the above blood picture requirements;
Biochemical indicators Serum total bilirubin (TBIL) ≤ 2.5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN, or 5 ULN if liver dysfunction is primarily due to tumor invasion); 6. Cardiac function: Subjects must have good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 55%; 7. Lung condition: Subjects are not serious infections such as severe pneumonia; 8. ECOG activity status score: 0-2 points; 9. Female subjects must use effective contraception (such as oral prescription contraceptives, injectable contraceptives, intrauterine devices, double blockade, contraceptive patches, male partner sterilization) throughout the study period; Must have a negative serum or urine pregnancy test result at screening and throughout the study.

Key exclusion criteria (19 listed)

Having received CAR-T therapy targeting the same molecule;
Having received other immunotargeted therapy targeting the same molecules;
Pregnant or lactating women;
Subjects who have previously suffered from other malignancies, with the following exceptions:
Subjects with a severe mental disorder;

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-TCAR T-cell therapy involves autologous chimeric antigen receptor T-cells, capable of targeting human B cell maturation antigen (BCMA) ,CD19 or CD-7 etc. target molecules of other hematologic malignancies.	Biological	Phase 1: High dose group, Phase 1: Medium dose group, Phase 1:Low dose group, Phase 2a: RP2D

Primary outcome

Number of patients with dose-limiting toxicity (DLT)
Time frame: Within 30 days of receiving CAR T-cells transfusion therapy
For DLT evaluation, severity (grade) is classified according to common terminology criteria for adverse events version 4.03 (CTCAE v4.03).
Maximum Tolerated Dose (MTD)
Time frame: Within 30 days of receiving CAR T-cells transfusion therapy
At least 6 subjects in the MTD dose group must complete the DLT assessment.
Adverse Event
Time frame: Minimum 2 years after CAR T-cells infusion (Day 1)
Safety will be assessed by adverse events (AEs), which include clinically significant abnormalities identified during medical tests (e.g. laboratory tests, electrocardiogram, imaging examinations or physical examinations). AEs will be coded by Medical Dictionary for Regulatory Activities (MeDRA) and their severity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).
Recommended Phase 2 Dose (RP2D)
Time frame: Through study completion, an average of 1 year
To determine after all subjects in the Phase 1 dose-escalation study completed DLT observation
Objective response rate (ORR)
Time frame: Through study completion, an average of 2 years
The definition of ORR is the proportion of subjects achieving sCR, CR, VGPR, or PR confirmed by efficacy reassessment after a minimum interval of three months. ORR is calculated as (sCR+CR+VGPR+PR) divided by the total number of cases of Multiple Myeloma, or (CR+PR) divided by the total number of cases of B-cell lymphoma and other hematologic malignancies, multiplied by 100%.

3 secondary outcomes

Stringent complete response rate (sCRR)
Time frame: Through study completion, an average of 2 years
Progression-free Survival (PFS)
Time frame: Through study completion, an average of 2 years
Overall Survival (OS)
Time frame: Through study completion, an average of 2 years

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 2025.
Results publication: PubMed 34464155Roddie C, Dias J, O'Reilly MA, Abbasian M, Cadinanos-Garai A, Vispute K, Bosshard-Carter L, Mitsikakou M, Mehra V, Roddy H, Hartley JA, Spanswick V, Lowe H, Popova B, Clifton-Hadley L, Wheeler G, Olejnik J, Bloor A, Irvine D, Wood L, Marzolini MAV, Domning S, Farzaneh F, Lowdell MW, Linch DC, Pule MA, Peggs KS. Durable Responses and Low Toxicity After Fast Off-Rate CD19 Chimeric Antigen Receptor-T Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. J Clin Oncol. 2021 Oct 20;39(30):3352-3363. doi: 10.1200/JCO.21.00917. Epub 2021 Aug 31.
Results publication: PubMed 35432352Sang W, Wang X, Geng H, Li T, Li D, Zhang B, Zhou Y, Song X, Sun C, Yan D, Li D, Li Z, Li C, Xu K. Anti-PD-1 Therapy Enhances the Efficacy of CD30-Directed Chimeric Antigen Receptor T Cell Therapy in Patients With Relapsed/Refractory CD30+ Lymphoma. Front Immunol. 2022 Apr 1;13:858021. doi: 10.3389/fimmu.2022.858021. eCollection 2022.
Results publication: PubMed 35488407Du J, Wei R, Jiang S, Jiang H, Li L, Qiang W, He H, Shi L, Ma Q, Yu K, Zhang X, Ding H, Sun X, Xiang F, Zhu L, Cheng Z, Fu W. CAR-T cell therapy targeting B cell maturation antigen is effective for relapsed/refractory multiple myeloma, including cases with poor performance status. Am J Hematol. 2022 Jul;97(7):933-941. doi: 10.1002/ajh.26583. Epub 2022 May 5.
Results publication: PubMed 35798714Yang J, He J, Zhang X, Li J, Wang Z, Zhang Y, Qiu L, Wu Q, Sun Z, Ye X, Yin W, Cao W, Shen L, Sersch M, Lu P. Next-day manufacture of a novel anti-CD19 CAR-T therapy for B-cell acute lymphoblastic leukemia: first-in-human clinical study. Blood Cancer J. 2022 Jul 7;12(7):104. doi: 10.1038/s41408-022-00694-6.
Results publication: PubMed 36059523Qu C, Zou R, Wang P, Zhu Q, Kang L, Ping N, Xia F, Liu H, Kong D, Yu L, Wu D, Jin Z. Decitabine-primed tandem CD19/CD22 CAR-T therapy in relapsed/refractory diffuse large B-cell lymphoma patients. Front Immunol. 2022 Aug 17;13:969660. doi: 10.3389/fimmu.2022.969660. eCollection 2022.
Results publication: PubMed 36477110Ying Z, Xie Y, Zheng W, Liu W, Lin N, Tu M, Wang X, Ping L, Deng L, Zhang C, Wu M, Feng F, Du T, Tang Y, Su F, Guo Z, Li J, Song Y, Zhu J. Efficacy and safety of relmacabtagene autoleucel, an anti-CD19 chimeric antigen receptor T cell, in relapsed/refractory B-cell non-Hodgkin's lymphoma: 2-year results of a phase 1 trial. Bone Marrow Transplant. 2023 Mar;58(3):288-294. doi: 10.1038/s41409-022-01888-z. Epub 2022 Dec 7.
Results publication: PubMed 37774014Liang EC, Albittar A, Huang JJ, Hirayama AV, Kimble EL, Portuguese AJ, Chapuis A, Shadman M, Till BG, Cassaday RD, Milano F, Kiem HP, Riddell SR, Turtle CJ, Maloney DG, Gauthier J. Factors associated with long-term outcomes of CD19 CAR T-cell therapy for relapsed/refractory CLL. Blood Adv. 2023 Nov 28;7(22):6990-7005. doi: 10.1182/bloodadvances.2023011399.
Results publication: PubMed 37883795Minson A, Hamad N, Cheah CY, Tam C, Blombery P, Westerman D, Ritchie D, Morgan H, Holzwart N, Lade S, Anderson MA, Khot A, Seymour JF, Robertson M, Caldwell I, Ryland G, Saghebi J, Sabahi Z, Xie J, Koldej R, Dickinson M. CAR T cells and time-limited ibrutinib as treatment for relapsed/refractory mantle cell lymphoma: the phase 2 TARMAC study. Blood. 2024 Feb 22;143(8):673-684. doi: 10.1182/blood.2023021306.
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.

Yan Yi, MD. contact

+86 13617493781

yiyan@smu.edu.cn

Yan Yi, MD. study director

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAR-T in people with Multiple Myeloma and B-cell Lymphoma, run by The Third Affiliated Hospital of Southern Medical University 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 5 inclusion and 19 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 6 Jan 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 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 Yan Yi, MD. (+86 13617493781, yiyan@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with dose-limiting toxicity (DLT) (time frame: Within 30 days of receiving CAR T-cells transfusion therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06758713, which also lists 8 linked publications.

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 2025.