CD5+ Relapsed/Refractory Hematopoietic MalignanciesEarly Phase 1NCT04767308
Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies
A Early Phase 1 study testing CT125A cells and Cyclophosphamide, fludarabine in people with CD5+ Relapsed/Refractory Hematopoietic Malignancies and Chronic Lymphocytic Leukemia (CLL), run by Huazhong University of Science and Technology.
Trial summary
Current treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CD5+ Relapsed/Refractory Hematopoietic Malignancies, Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphoma (MCL)
- What is being tested?
- CT125A cells and Cyclophosphamide, fludarabine
- Type of treatment
- 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
- Mar 2021to Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Subjects with CD5 positive B-cell lymphomas must meet the diagnostic criteria from National Comprehensive Cancer Network (NCCN) guidelines for B-Cell Lymphomas (2020.V1) and have CD5 expression on lymphoma cells (results within 60 days before informed consent signing are acceptable if current clinical condition is not suitable for sampling, and the investigator will judge whether the test results from other hospitals are acceptable and whether they can be enrolled); according to Lugano 2014 criteria, patients with B-cell lymphomas have at least one measurable lesion with the longest diameter ≥ 1.5 cm or bone marrow involvement detected by flow cytometry .
- Including:
- Chronic lymphocytic leukemia/small lymphocytic lymphoma: any BTK inhibitor have been given for at least 6 months and the treatment has failed (SD or PD).
- Mantle cell lymphoma (MCL): patients with MCL must have relapsed/refractory diseases after receiving at least one treatment regimen. Previous treatment must include chemotherapy with anthracyclines or bendamustine, anti-CD20 monoclonal antibody, and any BTK Inhibitor therapy.
- Diffuse large B-cell lymphoma: patients with diffuse large B-cell lymphoma who have failed or relapsed after at least two lines of therapy (a standard chemotherapy and a rescue chemotherapy); and meet one of the following conditions: a. unable to receive autologous hematopoietic stem cell transplantation (autoHSCT); b. refuse to receive autoHSCT; c. relapse after autoHSCT.
- 2.Subjects with CD5 positive peripheral T-cell lymphomas (PTCLs) are diagnosed according to criteria from World Health Organization classification for tumors of the hematopoietic and lymphoid tissues (2016 Edition) and have CD5 expression on lymphoma cells (results within 60 days before informed consent signing are acceptable if current clinical condition is not suitable for sampling, and the investigator will judge whether the test results from other hospitals are acceptable and whether they can be enrolled); according to Lugano 2014 criteria, patients with T-cell lymphomas must have at least one measurable lesion with the longest diameter ≥ 1.5 cm and no bone marrow involvement confirmed by flow cytometry and gene rearrangement (TCR/IGH) tests (and PET-CT results, if any, that must indicate no increased bone marrow metabolism); patients must fail or relapse after at least one line of therapy; including but not limited to the following PTCLs:
Show all 20Show fewer
- Peripheral T cell lymphoma - not otherwise specified (PTCL-NOS)
- Angioimmunoblastic lymphoma
- ALK negative anaplastic large cell lymphoma
- Extranodal NK/T cell lymphoma
- Enteropathy-associated T-cell lymphoma
- Large granular T lymphocyte leukemia
- Adult T cell leukemia
- 3.Age ≥18 and ≤70 years old, regardless of gender.
- 4.Expected life expectancy ≥12 weeks.
- 5.Serum total bilirubin ≤ 37.2 μmol/L (Gilbert syndrome patients ≤ 3.0 ULN, direct bilirubin ≤ 1.5 ULN), estimated glomerular filtration rate eGFR (CKD-EPI) ≥ 30 ml/min/1.73m2, alanine aminotransferase and aspartate aminotransferase less than 2.5 times the upper limit of normal range.
- 6.ECOG score 0-1 points.
- 7.Echocardiography suggests left ventricular ejection fraction (LVEF) ≥50%; blood oxygen saturation >91%.
- 8.After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year after CAR T cell infusion (excluding contraception safety periods). A negative pregnancy test must be obtained for female subjects.
- Subjects must provide written informed consent before the study begin.
Who cannot join
- Subjects who meet any of the following criteria will be excluded:
- History of allergies to any of the ingredients in cell products.
- Patients with acute GVHD judged to be grade II-Ⅳ by Glucksberg criteria or grade B-D by IBMTR index; acute or chronic GVHD patients who need systemic treatment within four weeks before enrollment.
- Injected with live vaccines within 4 weeks before enrollment.
- Central nervous system diseases not associated with lymphoma CNS invasion (such as cerebral aneurysm, epilepsy, stroke, senile dementia, psychosis, etc.). Lymphoma CNS invasion or digestive tract invasion is not considered as an exclusion criterion, but whether to be enrolled in the group is determined by the investigator.
- Severe active infection (except simple urinary tract infection and bacterial pharyngitis), or currently receiving intravenous antibiotic treatment. However, preventive antibiotics, antiviral and antifungal infection treatments are permitted.
Show all 24Show fewer
- Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA > 100 IU/mL.
- Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive.
- Subjects with other acquired and congenital immunodeficiency diseases, including but not limited to human immunodeficiency virus (HIV) antibody positive; subjects with cytomegalovirus (CMV) DNA > 400 copy/mL; subjects with syphilis test positive.
- Cardiac insufficiency of grade III or IV according to the New York Heart Association (NYHA) cardiac function classification criteria.
- History of other primary cancers, except for the following conditions:
- 1)Non-melanoma skin cancer with complete resection, such as basal cell carcinoma; 2)Cured carcinoma in situ such as cervical cancer, bladder cancer or breast cancer; 3)No recurrence of other primary cancers has been found for more than 5 years after treatment.
- 11.History of solid organ transplantation.
- 12.Subjects with previous autoimmune diseases (mainly abnormality of cellular immunity), immunodeficiency or subjects requiring immunosuppressive therapy.
- 13.Received other interventional clinical trial treatment within 3 months before signing ICF.
- 14.Pregnant or lactating women.
- 15.Suffer from mental illness or disturbance of consciousness or central nervous system disease.
- 16.The toxicity of previous treatment has not been relieved to baseline or ≤2 (NCI-CTCAE v5.0, except for hair loss).
- 17.Drug use:
- Steroid drugs: therapeutic dose of steroids used within 72 hours before CAR-T cell infusion, but physiological doses of steroid supplementation are allowed (<12mg/m2/day of hydrocortisone or its equivalent dose);
- Systemic anti-tumor therapy is not ended at least 2 weeks or 5 drug half-lives before apheresis (except for BTK inhibitors in CLL); interval between apheresis and immune checkpoint inhibitor treatment is less than 3 drug half-lives.
- 18.Active lung infection.
- 19.Contraindications for peripheral blood apheresis.
- 20. Subjects considered unsuitable for enrollment by the investigator for other reasons after careful consideration.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-center, Single-arm Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Fully Human Anti-CD5 Chimeric Antigen Receptor T Cells (CT125A Cells) for the Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies
Current treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Chimeric antigen receptor (CAR) T cells against CD5 offer another potential therapeutic option for patients with relapsed/refractory CD5 positive hematopoietic malignancies. In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ hematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR/Cas9 genome editing technology to prevent fratricide during CAR T cells manufacturing.
- Conditions
- CD5+ Relapsed/Refractory Hematopoietic Malignancies, Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphoma (MCL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Peripheral T-cell Lymphomas (PTCL)
- Being tested
- CT125A cells, Cyclophosphamide, fludarabine
- Keywords
- Adoptive T Cell Therapy, Chimeric antigen receptor, CD5 / Lymphocyte antigen T1/Leu-1, CD5+ hematopoietic malignancies
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT125A cellsBiological
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture CT125A cells, during which cyclophosphamide and fludarabine will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with CT125A cells by intravenous (IV) infusion. The initial dose of 1×10^6 CAR+ T cells/kg will be infused on day 0.
Cyclophosphamide, fludarabineDrug
Subjects will be given IV infusion of cyclophosphamide 500 mg/m2/day and fludarabine 30 mg/m2/day on days -4, -3 and -2
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | The tolerability and safety of CT125A cells will be assessed according to the "3+3" dose escalation design. There will be three dose levels, 1×10^6, 2×10^6, and 3×10^6, CAR+T cells/kg. For each level, 1-3 subjects will be enrolled. If no dose limited toxicity (DLT) occurs, next level will be assessed for DLT. If DLT occurs in one subject, 3 more subjects will be enrolled in this cohort for the evaluation of DLT. If DLT occurs in ≤ 1/6 subjects, next level will be assessed for DLT. If DLT occurs in ≥ 2 subjects, no more subjects will be enrolled in this cohort and dose escalation will be canceled. For each cohort, following subjects can only receive CT125A infusion at least 14 days after the first subject received CT125A infusion. If DLT occurs in 2 subjects at Dose Level 1, whether to explore a lower dose will be determined by the investigator. After dose escalation phase is completed, the dose for extension phase will be determined based on safety and PK data. Receives: Biological: CT125A cells; Drug: Cyclophosphamide, fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and types of dose limited toxicities (DLTs) following infusion of CT125A chimeric antigen receptor (CAR) T cells
Incidence and types of dose limited toxicities (DLTs) after administration of CT125A cells in patients with relapsed/refractory CD5+ hematopoietic malignancies will be recorded at 3 dose levels to investigate the maximum tolerated dose of CT125A. DLT is defined as the following adverse events that occur during the first 28 days after CT125A infusion and are definitely or probably related to CT125A cells: 1) Cytokine release syndrome equal or greater than grade 4 lasting longer than 3 days graded by ASTCT 2019 consensus; 2) Grade 4 immune effector cell-associated neurotoxicity syndrome graded by ASTCT 2019 consensus; 3) Grade 4 hematological toxicity lasting longer than 28 days except for T cell aplasia; 4) Non-hematological toxicity equal or greater than grade 3 lasting longer than 7 days or Grade 4 non-hematological toxicity lasting longer than 3 days.
Measured: 28 days after CAR T cell infusion
Incidence and severity of adverse events (AEs) following infusion of CT125A chimeric antigen receptor (CAR) T cells
Incidence of adverse events (AEs) after administration of each dose of CT125A cells in patients with relapsed/refractory CD5+ hematopoietic malignancies will be recorded and the severity of AEs will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 except that cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome will be graded according to the consensus by ASTCT in 2019. AE is defined as any untoward medical occurrence in a patient after CAR T cell infusion and which does not necessarily have a causal relationship with this treatment.
Measured: 2 years after CAR T cell infusion
Secondary outcomes (3)
Overall response rate (ORR) at 4th week and 12th week
At 4 weeks and 12 weeks after CT125A infusion, the response rate of subjects that are evaluated as complete response (CR) and partial response (PR) according to Lugano 2014 criteria will be measured
Measured: 12 weeks after CAR T cell infusion
Time to first response after CT125A cells infusion
The number of days elapsed between the time when subjects receive CT125A infusion and the time when the response is first evaluated as partial response (PR) or complete response (CR) will be measured
Measured: 2 years after CAR T cell infusion
Time to complete response (CR) after CT125A infusion
The number of days elapsed between the time when subjects receive CT125A infusion and the time when the response is first evaluated as complete response (CR) will be measured
Measured: 2 years after CAR T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CD5+ Relapsed/Refractory Hematopoietic MalignanciesStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai IASO Biotechnology Co., Ltd
- Responsible party
- Principal investigator, Jianfeng Zhou, Huazhong University of Science and Technology
- Investigators
- Jianfeng Zhou, PhD, MD, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767308
- Sponsor's protocol ID
- CT125ACI001
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified participant data that underlie the results published will be shared in the publication. Data will be available upon request and after the approval of data request proposal.
Publications
Cheng J, Zhu L, Wu J, Zeng Y, Mao X, Ding S, Wang J, Xiao Y, Zhou X, Mu W, Zhu X. Efficacy and safety of autologous CD5-KO anti-CD5 CAR-T cells in relapsed/refractory CD5+ hematological malignancies. Cell Rep Med. 2026 Feb 17;7(2):102584. doi: 10.1016/j.xcrm.2026.102584. Epub 2026 Feb 2.
PubMed 41633358Mu W, Zhang M, Hu G, Han Y, Mao X, Chen C, Shen K, Dai Z, Zhu X, Zhou X, Huang L, Ao Q, Xiao M. Case report: Differential diagnosis of highly amplified anti-CD5 CAR T cells and relapsed lymphoma cells in a patient with refractory ALK positive anaplastic large cell lymphoma. Front Immunol. 2023 Dec 8;14:1280007. doi: 10.3389/fimmu.2023.1280007. eCollection 2023.
PubMed 38143760
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Fully Human Anti-CD5 Chimeric Antigen Receptor T Cells (CT125A Cells) for the Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies
- ClinicalTrials.gov ID
- NCT04767308
- Acronym / sponsor ID
- CT125ACI001
- Conditions
- CD5+ Relapsed/Refractory Hematopoietic Malignancies, Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphoma (MCL), Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Peripheral T-cell Lymphomas (PTCL)
- Keywords
- Adoptive T Cell Therapy, Chimeric antigen receptor, CD5 / Lymphocyte antigen T1/Leu-1, CD5+ hematopoietic malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Shanghai IASO Biotechnology Co., Ltd
- Study start
- Mar 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Feb 2021 (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.
Current treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Chimeric antigen receptor (CAR) T cells against CD5 offer another potential therapeutic option for patients with relapsed/refractory CD5 positive hematopoietic malignancies. In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ hematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR/Cas9 genome editing technology to prevent fratricide during CAR T cells manufacturing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: CT125A cells, Drug: Cyclophosphamide, fludarabineThe tolerability and safety of CT125A cells will be assessed according to the "3+3" dose escalation design. There will be three dose levels, 1×10^6, 2×10^6, and 3×10^6, CAR+T cells/kg. For each level, 1-3 subjects will be enrolled. If no dose limited toxicity (DLT) occurs, next level will be assessed for DLT. If DLT occurs in one subject, 3 more subjects will be enrolled in this cohort for the evaluation of DLT. If DLT occurs in ≤ 1/6 subjects, next level will be assessed for DLT. If DLT occurs in ≥ 2 subjects, no more subjects will be enrolled in this cohort and dose escalation will be canceled. For each cohort, following subjects can only receive CT125A infusion at least 14 days after the first subject received CT125A infusion. If DLT occurs in 2 subjects at Dose Level 1, whether to explore a lower dose will be determined by the investigator. After dose escalation phase is completed, the dose for extension phase will be determined based on safety and PK data. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 1.Subjects with CD5 positive B-cell lymphomas must meet the diagnostic criteria from National Comprehensive Cancer Network (NCCN) guidelines for B-Cell Lymphomas (2020.V1) and have CD5 expression on lymphoma cells (results within 60 days before informed consent signing are acceptable if current clinical condition is not suitable for sampling, and the investigator will judge whether the test results from other hospitals are acceptable and whether they can be enrolled); according to Lugano 2014 criteria, patients with B-cell lymphomas have at least one measurable lesion with the longest diameter ≥ 1.5 cm or bone marrow involvement detected by flow cytometry .
- Chronic lymphocytic leukemia/small lymphocytic lymphoma: any BTK inhibitor have been given for at least 6 months and the treatment has failed (SD or PD).
- Mantle cell lymphoma (MCL): patients with MCL must have relapsed/refractory diseases after receiving at least one treatment regimen. Previous treatment must include chemotherapy with anthracyclines or bendamustine, anti-CD20 monoclonal antibody, and any BTK Inhibitor therapy.
- Diffuse large B-cell lymphoma: patients with diffuse large B-cell lymphoma who have failed or relapsed after at least two lines of therapy (a standard chemotherapy and a rescue chemotherapy); and meet one of the following conditions: a. unable to receive autologous hematopoietic stem cell transplantation (autoHSCT); b. refuse to receive autoHSCT; c. relapse after autoHSCT.
- 2.Subjects with CD5 positive peripheral T-cell lymphomas (PTCLs) are diagnosed according to criteria from World Health Organization classification for tumors of the hematopoietic and lymphoid tissues (2016 Edition) and have CD5 expression on lymphoma cells (results within 60 days before informed consent signing are acceptable if current clinical condition is not suitable for sampling, and the investigator will judge whether the test results from other hospitals are acceptable and whether they can be enrolled); according to Lugano 2014 criteria, patients with T-cell lymphomas must have at least one measurable lesion with the longest diameter ≥ 1.5 cm and no bone marrow involvement confirmed by flow cytometry and gene rearrangement (TCR/IGH) tests (and PET-CT results, if any, that must indicate no increased bone marrow metabolism); patients must fail or relapse after at least one line of therapy; including but not limited to the following PTCLs:
Key exclusion criteria (24 listed)
- History of allergies to any of the ingredients in cell products.
- Patients with acute GVHD judged to be grade II-Ⅳ by Glucksberg criteria or grade B-D by IBMTR index; acute or chronic GVHD patients who need systemic treatment within four weeks before enrollment.
- Injected with live vaccines within 4 weeks before enrollment.
- Central nervous system diseases not associated with lymphoma CNS invasion (such as cerebral aneurysm, epilepsy, stroke, senile dementia, psychosis, etc.). Lymphoma CNS invasion or digestive tract invasion is not considered as an exclusion criterion, but whether to be enrolled in the group is determined by the investigator.
- Severe active infection (except simple urinary tract infection and bacterial pharyngitis), or currently receiving intravenous antibiotic treatment. However, preventive antibiotics, antiviral and antifungal infection treatments are permitted.
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 |
|---|---|---|
| CT125A cellsSubjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture CT125A cells, during which cyclophosphamide and fludarabine will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with CT125A cells by intravenous (IV) infusion. The initial dose of 1×10^6 CAR+ T cells/kg will be infused on day 0. | Biological | Arm 1 |
| Cyclophosphamide, fludarabineSubjects will be given IV infusion of cyclophosphamide 500 mg/m2/day and fludarabine 30 mg/m2/day on days -4, -3 and -2 | Drug | Arm 1 |
Primary outcome
Incidence and types of dose limited toxicities (DLTs) following infusion of CT125A chimeric antigen receptor (CAR) T cells
Time frame: 28 days after CAR T cell infusion
Incidence and types of dose limited toxicities (DLTs) after administration of CT125A cells in patients with relapsed/refractory CD5+ hematopoietic malignancies will be recorded at 3 dose levels to investigate the maximum tolerated dose of CT125A. DLT is defined as the following adverse events that occur during the first 28 days after CT125A infusion and are definitely or probably related to CT125A cells: 1) Cytokine release syndrome equal or greater than grade 4 lasting longer than 3 days graded by ASTCT 2019 consensus; 2) Grade 4 immune effector cell-associated neurotoxicity syndrome graded by ASTCT 2019 consensus; 3) Grade 4 hematological toxicity lasting longer than 28 days except for T cell aplasia; 4) Non-hematological toxicity equal or greater than grade 3 lasting longer than 7 days or Grade 4 non-hematological toxicity lasting longer than 3 days.
Incidence and severity of adverse events (AEs) following infusion of CT125A chimeric antigen receptor (CAR) T cells
Time frame: 2 years after CAR T cell infusion
Incidence of adverse events (AEs) after administration of each dose of CT125A cells in patients with relapsed/refractory CD5+ hematopoietic malignancies will be recorded and the severity of AEs will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 except that cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome will be graded according to the consensus by ASTCT in 2019. AE is defined as any untoward medical occurrence in a patient after CAR T cell infusion and which does not necessarily have a causal relationship with this treatment.
3 secondary outcomes
Overall response rate (ORR) at 4th week and 12th week
Time frame: 12 weeks after CAR T cell infusion
Time to first response after CT125A cells infusion
Time frame: 2 years after CAR T cell infusion
Time to complete response (CR) after CT125A infusion
Time frame: 2 years after CAR T cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Derived from this study: PubMed 41633358Cheng J, Zhu L, Wu J, Zeng Y, Mao X, Ding S, Wang J, Xiao Y, Zhou X, Mu W, Zhu X. Efficacy and safety of autologous CD5-KO anti-CD5 CAR-T cells in relapsed/refractory CD5+ hematological malignancies. Cell Rep Med. 2026 Feb 17;7(2):102584. doi: 10.1016/j.xcrm.2026.102584. Epub 2026 Feb 2.
- Derived from this study: PubMed 38143760Mu W, Zhang M, Hu G, Han Y, Mao X, Chen C, Shen K, Dai Z, Zhu X, Zhou X, Huang L, Ao Q, Xiao M. Case report: Differential diagnosis of highly amplified anti-CD5 CAR T cells and relapsed lymphoma cells in a patient with refractory ALK positive anaplastic large cell lymphoma. Front Immunol. 2023 Dec 8;14:1280007. doi: 10.3389/fimmu.2023.1280007. eCollection 2023.
- Individual participant dataSharing planned: Yes. Individual deidentified participant data that underlie the results published will be shared in the publication. Data will be available upon request and after the approval of data request proposal.
Related trials for CD5+ Relapsed/Refractory Hematopoietic Malignancies
Recruiting
CD5 CART for the Treatment of Relapsed and Refractory CD5 Hematological Tumors
Relapsed and Refractory CD5 Hematological Tumors
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. This study is not recruiting at the moment.
Jianfeng Zhou, PhD, MD principal investigator
Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CT125A cells and Cyclophosphamide, fludarabine in people with CD5+ Relapsed/Refractory Hematopoietic Malignancies and Chronic Lymphocytic Leukemia (CLL), run by Huazhong University of Science and Technology.
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 20 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Zhou, PhD, MD (86-27-83662680, jfzhou@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and types of dose limited toxicities (DLTs) following infusion of CT125A chimeric antigen receptor (CAR) T cells (time frame: 28 days after CAR T cell infusion). The study lists 2 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 NCT04767308, which also lists 2 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 23 Feb 2021.