CAR-T Cell TherapyPhase 1CAR-T TherapyNCT06647329
CAR-T Technology for Recurrent/Refractory Malignant Hematological and Lymphatic Tumors
A Phase 1 study testing CAR-T Therapy in people with CAR-T Cell Therapy and Lymphomas, run by Mingzhi Zhang at 1 site in China.
Trial summary
evaluate the safety and Esfficacy of CAR-T technology for the treatment of recurrent/refractory malignant hematological lymphomas Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- CAR-T Cell Therapy, Lymphomas
- What is being tested?
- CAR-T Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2026
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -
- Participants must meet all of the following conditions to be included:
- The participant has given informed consent and signed the consent form, and is willing and capable of complying with the scheduled visits, study treatment, laboratory examinations, and other trial procedures.
- Clinically diagnosed as having relapsed/refractory malignant hematologic tumors:
- 2.1 Diagnosed as CD19+ and/or CD20+ and/or CD22+ B-cell tumors through pathological and histological examinations, and the participant meets the criteria for relapsed or refractory B-cell malignancies as follows:
- B-cell tumors include the following three categories:
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- B-cell acute lymphoblastic leukemia (B-ALL); B. Indolent B-cell lymphomas (CLL, FL, MZL, LPL, HCL); C. Aggressive B-cell lymphomas (DLBCL, BL, MCL).
- 2.1.1. Refractory/relapsed B-cell leukemia (meeting one of the following four criteria): A. Relapse within 6 months after initial remission; B. Initial refractory after 2 cycles of standard chemotherapy without achieving complete remission; C. Relapse or refractory after first-line or multi-line salvage chemotherapy without achieving complete remission; D. Not suitable for hematopoietic stem cell transplantation, or have abandoned transplantation due to conditions, or relapse after transplantation.
- 2.1.2. Refractory/relapsed B-cell lymphoma (meeting one of the first four criteria plus the fifth): A. Tumor shrinkage of less than 50% or disease progression after 4 cycles of standard chemotherapy; B. Achieved CR after standard chemotherapy, but relapsed within 6 months; C. Relapsed 2 times or more after achieving CR; D. Not suitable for hematopoietic stem cell transplantation, or have abandoned transplantation due to conditions, or relapse after transplantation;
- The participant must have received sufficient prior treatment, including at least:
- Anti-CD20 monoclonal antibodies
- Combination chemotherapy containing anthracyclines.
- 2.2 Refractory/relapsed multiple myeloma: Progressed after at least 3 lines of treatment (at least one proteasome inhibitor and one immunomodulator used).
- 2.3 Presence of measurable or evaluable lesions: A. For lymphoma patients, a single lesion ≥15 mm or two or more lesions ≥10 mm, or PET-positive lesions determined according to Lugano criteria; B. For leukemia and myeloma patients, bone marrow MRD must be persistently positive or positive relapse.
- Age 14-75 years (inclusive), both male and female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Treatment-related antigen test results must be positive:
- For lymphoma: CD19/CD20/CD22 (immunohistochemical results positive within six months); B. For acute lymphoblastic leukemia: CD19/CD22 (tumor cells detected positive by flow cytometry in bone marrow at screening, or extramedullary lesions with positive immunohistochemistry results within six months); C.For multiple myeloma: BCMA (tumor cells detected positive by flow cytometry in bone marrow at screening, or extramedullary lesions with positive immunohistochemistry results within six months).
- Expected survival time greater than 3 months from the date of signing the informed consent form.
- HGB ≥ 70 g/L (transfusion allowed).
- Liver and kidney function, and cardiopulmonary function must 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.
- Participants with a plan for pregnancy must agree to use contraception before enrollment and for six months after the study begins; if the participant becomes pregnant or suspects pregnancy, they must immediately notify the investigator.
Who cannot join
- Participants who meet any of the following conditions are not eligible for inclusion:
- History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) class III or IV heart failure, cardiovascular intervention (angioplasty or stenting), myocardial infarction, unstable angina, or other clinically significant heart diseases.
- History of severe pulmonary dysfunction.
- Concurrent advanced malignant tumors.
- Concurrent systemic fungal, bacterial, viral, or other infections that cannot be effectively controlled.
- Concurrent severe autoimmune diseases or congenital immunodeficiency.
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- Active hepatitis (positive HBV DNA or HCV RNA testing).
- Human Immunodeficiency Virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
- History of severe allergic reactions to biologics (including antibiotics).
- Less than 6 months since undergoing allogeneic hematopoietic stem cell transplantation.
- Acute or chronic graft-versus-host disease (GvHD).
- History of deep vein thrombosis (DVT) (cancer-related thrombosis) or pulmonary embolism (PE) within 3 months prior to signing the informed consent form.
- Anticoagulation treatment for DVT or PE within 3 months prior to signing the informed consent form.
- History or clinical significance of CNS diseases at screening, such as epilepsy, seizure disorders, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or mental disorders.
- Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the start of lymphocyte-depleting chemotherapy.
- Use of any of the following medications or treatments within the specified time before leukapheresis:
- Use of alemtuzumab within the past 6 months prior to leukapheresis; B. Use of anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis; C. Use of Venetoclax within 4 days prior to leukapheresis; D. Use of lenalidomide within 3 days prior to leukapheresis; E. Use of Idelalisib within 2 days prior to leukapheresis; F. Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent > 20 mg/day) within 7 days prior to leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted; G. Use of investigational drugs within 4 weeks prior to leukapheresis. However, if treatment was ineffective or the disease progressed during the trial and at least 3 half-lives have elapsed before leukapheresis, enrollment is allowed; H. Received donor lymphocyte infusion (DLI) within 6 weeks prior to CAR-T administration.
- Any factors judged by the investigator that may affect compliance with the study protocol, including uncontrollable medical, psychological, familial, sociological, or geographical factors, or unwillingness or inability to comply with the required procedures of the study protocol.
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
the First Hospital of Zhengzhou University
Zhengzhou, Henan, 470000
Mingzhi Zhang, 86 13838565629, mingzhi_zhang1@126.com
About this study
Official title: CAR-T Technology for the Treatment of Recurrent/Refractory Malignant Hematological and Lymphatic Tumors: Multi-Center Clinical Study on Safety and Efficacy
evaluate the safety and Esfficacy of CAR-T technology for the treatment of recurrent/refractory malignant hematological lymphomas
Read the detailed description
Patients with recurrent/refractory malignant hematological lymphomas were treated with CAR-T technology
- Conditions
- CAR-T Cell Therapy, Lymphomas
- Being tested
- CAR-T Therapy
- Keywords
- CAR-T therapy, Recurrent/Refractory Malignant Hematological Lymphomas
- Medical subject headings
- Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T TherapyBiological
CAR-T Technology for the Treatment of Recurrent/Refractory Malignant Hematological Lymphomas
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | CAR-T therapy Receives: Biological: CAR-T Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate(ORR)
evaluate the efficacy of CAR-T cell infusion for the treatment of relapsed/refractory malignant hematological tumors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAR-T Cell TherapyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingzhi Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingzhi Zhang, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647329
- Sponsor's protocol ID
- hnslblCAR-T
- Acronym
- CAR-T Therapy
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR-T Technology for the Treatment of Recurrent/Refractory Malignant Hematological and Lymphatic Tumors: Multi-Center Clinical Study on Safety and Efficacy
- ClinicalTrials.gov ID
- NCT06647329
- Acronym / sponsor ID
- CAR-T Therapy / hnslblCAR-T
- Conditions
- CAR-T Cell Therapy, Lymphomas
- Keywords
- CAR-T therapy, Recurrent/Refractory Malignant Hematological Lymphomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Oct 2024 (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.
evaluate the safety and Esfficacy of CAR-T technology for the treatment of recurrent/refractory malignant hematological lymphomas
Detailed description
Patients with recurrent/refractory malignant hematological lymphomas were treated with CAR-T technology
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: CAR-T TherapyCAR-T therapy |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- -
- The participant has given informed consent and signed the consent form, and is willing and capable of complying with the scheduled visits, study treatment, laboratory examinations, and other trial procedures.
- Clinically diagnosed as having relapsed/refractory malignant hematologic tumors:
- 2.1 Diagnosed as CD19+ and/or CD20+ and/or CD22+ B-cell tumors through pathological and histological examinations, and the participant meets the criteria for relapsed or refractory B-cell malignancies as follows:
- 2.1.1. Refractory/relapsed B-cell leukemia (meeting one of the following four criteria): A. Relapse within 6 months after initial remission; B. Initial refractory after 2 cycles of standard chemotherapy without achieving complete remission; C. Relapse or refractory after first-line or multi-line salvage chemotherapy without achieving complete remission; D. Not suitable for hematopoietic stem cell transplantation, or have abandoned transplantation due to conditions, or relapse after transplantation.
Key exclusion criteria (18 listed)
- History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) class III or IV heart failure, cardiovascular intervention (angioplasty or stenting), myocardial infarction, unstable angina, or other clinically significant heart diseases.
- History of severe pulmonary dysfunction.
- Concurrent advanced malignant tumors.
- Concurrent systemic fungal, bacterial, viral, or other infections that cannot be effectively controlled.
- Concurrent 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 |
|---|---|---|
| CAR-T TherapyCAR-T Technology for the Treatment of Recurrent/Refractory Malignant Hematological Lymphomas | Biological | Treatment |
Primary outcome
objective response rate(ORR)
Time frame: 6 months
evaluate the efficacy of CAR-T cell infusion for the treatment of relapsed/refractory malignant hematological tumors
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 17 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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 study testing CAR-T Therapy in people with CAR-T Cell Therapy and Lymphomas, run by Mingzhi Zhang 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 22 inclusion and 18 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 17 Oct 2024. 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 Zhang Mingzhi Zhang PhD (86 13838565629, mingzhi_zhang1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate(ORR) (time frame: 6 months). 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 17 Oct 2024.