Relapsed and Refractory CD5 Hematological TumorsNCT07234110
CD5 CART for the Treatment of Relapsed and Refractory CD5 Hematological Tumors
A study testing Fully human CD5 chimeric antigen receptor T cell injection in people with Relapsed and Refractory CD5 Hematological Tumors, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is an investigator-initiated dose-finding clinical study with the primary objective of evaluating the safety of CD5CART in the treatment of subjects with relapsed and refractory CD5 hematological malignancies and to explore the MTD of CD5CART treatment of relapsed and refractory subjects with CD5 hematological… Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Relapsed and Refractory CD5 Hematological Tumors
- What is being tested?
- Fully human CD5 chimeric antigen receptor T cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2025to 31 Oct 2027
- Phase
- Interventional
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be enrolled:
- 1. CD5-positive B-cell lymphoma: B-cell lymphoma confirmed according to the National Comprehensive Cancer Network (NCCN) B-cell lymphoma clinical practice guidelines (2020 1st edition), and the tumor surface expresses CD5 (the test results within 60 days before signing the notice are acceptable for clinical practice, and the investigator will judge whether the test results of other hospitals are acceptable and whether they can be enrolled); According to the 2014 Lugano criteria, patients with B-cell lymphoma have at least one measurable lesion with a longest diameter ≥ 1.5 cm or bone marrow flow cytometry suggests bone marrow invasion, including:
- Chronic lymphocytic leukemia/small lymphocytic lymphoma: Received any BTK inhibitor for at least 6 months and was ineffective (disease is in SD or PD state).
- Mantle cell lymphoma: Relapsed/refractory disease with at least one treatment regimen, prior treatment must include chemotherapy with anthracyclines or bendamustine, anti-CD20 monoclonal antibody, and therapy with any BTK inhibitor.
- Diffuse large B-cell lymphoma: Patients with diffuse large B-cell lymphoma who have refractory or relapsed after at least second-line therapy (one standard chemotherapy regimen and one salvage chemotherapy). At the same time, one of the following conditions is met: a. Unable to receive autologous hematopoietic stem cell transplantation; b. Refusal to receive autologous hematopoietic stem cell transplantation; c. Relapse after autologous hematopoietic stem cell transplantation.
- 2. CD5-positive T-cell lymphoma: Peripheral T-cell lymphoma confirmed according to the 2016 WHO classification criteria and the tumor surface expresses CD5 (if the current clinical practice is not suitable for sampling, the test results within 60 days before signing the information are acceptable, and the investigator will judge whether the test results of the other hospital are acceptable and whether they can be enrolled); According to the 2014 Lugano criteria, patients with T-cell lymphoma have at least one measurable lesion with a longest diameter ≥ 1.5 cm and no bone marrow invasion determined by bone marrow flow cytometry and receptor gene rearrangement (TCR/IGH) testing (and if PET-CT is available, it must not indicate elevated bone marrow metabolism); Refractory or relapsed after at least first-line therapy, including, but not limited to, the following peripheral T-cell lymphomas:
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- Peripheral T-cell lymphoma (non-specific type)
- angioimmunoblastic lymphoma
- ALK-negative mesentomas large cell lymphoma
- extranodal NK/T-cell lymphoma
- enteropathy-associated T-cell lymphoma
- Large granular T lymphocytic leukemia
- Other CD5 T-cell tumors such as adult T-cell leukemia, such as acute T-lymphoblastic leukemia/T-lymphoblastic lymphoma, etc 3. Age ≥ 18 and ≤ 70 years old, male or female. 4. Expected survival ≥ 12 weeks. 5. Serum total bilirubin ≤ 37.2 μmol/L (serum total bilirubin ≤ 3.0 ULN and direct bilirubin ≤1.5 ULN in patients with Gilbert syndrome), estimated glomerular filtration rate eGFR (CKD-EPI) ≥ 30 ml/min/1.73m2, alanine aminotransferase and aspartate aminotransferase are less than 2.5 times the upper limit of the normal range.
- 6. ECOG score 0-1 points. 7. Left ventricular ejection fraction (LVEF) ≥ 50% of the subjects diagnosed by echocardiography; Blood oxygen saturation > 91%.
- 8. Subjects and their spouses agree to take effective tools or drug contraceptives within one year after the subject signs the informed consent form until one year after CAR-T cell retransfusion; Female subjects of childbearing potential must have a negative serum or urine pregnancy test during the screening period.
- 9. Volunteer to participate in this trial and sign the informed consent form.
Who cannot join
- Subjects who meet any of the following criteria will be excluded:
- Those who have a history of allergy to any component of cell products.
- Grade II-IV. acute GVHD determined by Glucksberg criteria or grade B-D severity determined by IBMTR index; Patients with acute or chronic GVHD who required systemic treatment within four weeks prior to enrollment.
- Subjects who have been injected with live vaccines within 4 weeks before enrollment.
- Central nervous system diseases that are not related to lymphoma central invasion (such as brain aneurysm, epilepsy, stroke, Alzheimer's, psychosis, etc.). Lymphoma central invasion or gastrointestinal invasion is not used as an exclusion criterion, but enrollment is at the discretion of the investigator.
- Serious active infection (except uncomplicated urinary tract infection, bacterial pharyngitis), or currently receiving intravenous antibiotic therapy. However, prophylactic antibiotic, antiviral, and antifungal treatment for infections is allowed.
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- Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA detection value > 100 IU/mL.
- Those who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood.
- Subjects with other acquired and congenital immunodeficiency diseases, including but not limited to those who are positive for human immunodeficiency virus (HIV) antibodies; Subjects with cytomegalovirus (CMV) DNA detection value > 400 copies/mL; Those who test positive for syphilis.
- Subjects with cardiac insufficiency of class III or IV according to the New York Heart Association (NYHA) cardiac function grading criteria (see Appendix 2).
- Subject has a history of other primary cancers, except for the following:
- 1) Non-melanoma cured by resection such as basal cell carcinoma of the skin; 2) Cured carcinoma in situ such as cervical cancer, bladder cancer or breast cancer, etc.; 3) No recurrence of other primary cancers after treatment for more than 5 years.
- 11. History of solid organ transplantation. 12. Subjects with previous autoimmune diseases (mainly cellular immune abnormalities), immunodeficiency or subjects requiring immunosuppressant therapy.
- 13. Receiving other interventional clinical trial drugs within 3 months before signing the informed consent form (ICF); 14. Women who are pregnant or breastfeeding; 15. Suffering from mental illness or consciousness disorder or central nervous system disease; 16. Previous treatment toxicity has not been resolved to baseline or grade ≤2 (NCI-CTCAE v5.0, except alopecia); 17. Medication use:
- Steroid medications: Therapeutic doses of steroids were used within 72 hours prior to CAR-T cell infusion, but physiologic doses of steroid supplementation are allowed (< 12mg/m2/day of hydrocortisone or its equivalent;
- Systemic anti-tumor therapy requires at least 2 weeks or 5 half-lives of the drug before T cell collection (except for BTK inhibitors in CLL); T cells were collected from immune checkpoint inhibitors with an interval of less than 3 drug half-lives.
- 18. Active pulmonary infection. 19. Contraindications to peripheral blood apheresis. 20. Subjects who are considered unsuitable to participate in this trial by the investigator after careful consideration.
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
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Liang Huang, 022-23608106, huangliang@ihcams.ac.cn
About this study
Official title: Single-center, Single-arm Exploratory Clinical Study on the Safety and Efficacy of Human CD5 Chimeric Antigen Receptor T Cell Injection CD5CART in the Treatment of Relapsed and Refractory CD5+ Hematologic Cancer Subjects
This is an investigator-initiated dose-finding clinical study with the primary objective of evaluating the safety of CD5CART in the treatment of subjects with relapsed and refractory CD5 hematological malignancies and to explore the MTD of CD5CART treatment of relapsed and refractory subjects with CD5 hematological malignancies. At the same time, the effectiveness and pharmacokinetic characteristics of CD5CART treatment of relapsed and refractory CD5 hematological tumors in subjects were explored
- Being tested
- Fully human CD5 chimeric antigen receptor T cell injection
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully human CD5 chimeric antigen receptor T cell injectionDrug
CA5 CART cells were reinfused
| Study group | Role | What they receive |
|---|---|---|
| Fully human CD5 chimeric antigen receptor T cell injection | Experimental | Not described Receives: Drug: Fully human CD5 chimeric antigen receptor T cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main objectives
To evaluate the safety of CD5 chimeric antigen receptor T cell injection (CD5CART) in the treatment of subjects with relapsed and refractory CD5 hematological tumors, and to explore the maximum tolerated dose (MTD).
Measured: one month
Secondary outcomes (6)
ORR
The proportion of subjects evaluated as complete response (CR) and partial response (PR) according to Lugano 2014 efficacy evaluation criteria after CD5CART infusion
Measured: weeks 4 and 12 after CAR-T infusion
Time to Response (TTR)
Time from CAR-T infusion to first documentation of response evaluated by an IRC or investigators
Measured: in 2 years post CAR-T infusion
Best overall response rate (BOR)
The proportion of subjects who received CD5CART infusion and had the best efficacy evaluation as PR or CR
Measured: within 3 months post CAR-T infusion
Duration of response (DOR)
The time from the first assessment of CR/PR to the first assessment of PD or death from any cause in the subject after receiving CD5CART infusion
Measured: Minimum of 2 years post CAR-T infusion
Progression-free Survival (PFS)
The time from CD5CART infusion to the first occurrence of disease progression or death from any cause in the efficacy assessment of the subject;
Measured: Minimum of 2 years post CAR-T infusion
Overall survival (OS)
Time from CAR-T infusion to time of death due to any cause
Measured: Minimum of 2 years post CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start3 Sep 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory CD5 Hematological TumorsStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Gaobo Boren Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234110
- Sponsor's protocol ID
- IIT2024092
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2025
- Last updated
- 30 Jun 2026
- Results posted
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Single-arm Exploratory Clinical Study on the Safety and Efficacy of Human CD5 Chimeric Antigen Receptor T Cell Injection CD5CART in the Treatment of Relapsed and Refractory CD5+ Hematologic Cancer Subjects
- ClinicalTrials.gov ID
- NCT07234110
- Acronym / sponsor ID
- IIT2024092
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Beijing Gaobo Boren Hospital
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 18 Nov 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 is an investigator-initiated dose-finding clinical study with the primary objective of evaluating the safety of CD5CART in the treatment of subjects with relapsed and refractory CD5 hematological malignancies and to explore the MTD of CD5CART treatment of relapsed and refractory subjects with CD5 hematological malignancies. At the same time, the effectiveness and pharmacokinetic characteristics of CD5CART treatment of relapsed and refractory CD5 hematological tumors in subjects were explored
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fully human CD5 chimeric antigen receptor T cell injection | Experimental | Drug: Fully human CD5 chimeric antigen receptor T cell injection |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 1. CD5-positive B-cell lymphoma: B-cell lymphoma confirmed according to the National Comprehensive Cancer Network (NCCN) B-cell lymphoma clinical practice guidelines (2020 1st edition), and the tumor surface expresses CD5 (the test results within 60 days before signing the notice are acceptable for clinical practice, and the investigator will judge whether the test results of other hospitals are acceptable and whether they can be enrolled); According to the 2014 Lugano criteria, patients with B-cell lymphoma have at least one measurable lesion with a longest diameter ≥ 1.5 cm or bone marrow flow cytometry suggests bone marrow invasion, including:
- Chronic lymphocytic leukemia/small lymphocytic lymphoma: Received any BTK inhibitor for at least 6 months and was ineffective (disease is in SD or PD state).
- Mantle cell lymphoma: Relapsed/refractory disease with at least one treatment regimen, prior treatment must include chemotherapy with anthracyclines or bendamustine, anti-CD20 monoclonal antibody, and therapy with any BTK inhibitor.
- Diffuse large B-cell lymphoma: Patients with diffuse large B-cell lymphoma who have refractory or relapsed after at least second-line therapy (one standard chemotherapy regimen and one salvage chemotherapy). At the same time, one of the following conditions is met: a. Unable to receive autologous hematopoietic stem cell transplantation; b. Refusal to receive autologous hematopoietic stem cell transplantation; c. Relapse after autologous hematopoietic stem cell transplantation.
- 2. CD5-positive T-cell lymphoma: Peripheral T-cell lymphoma confirmed according to the 2016 WHO classification criteria and the tumor surface expresses CD5 (if the current clinical practice is not suitable for sampling, the test results within 60 days before signing the information are acceptable, and the investigator will judge whether the test results of the other hospital are acceptable and whether they can be enrolled); According to the 2014 Lugano criteria, patients with T-cell lymphoma have at least one measurable lesion with a longest diameter ≥ 1.5 cm and no bone marrow invasion determined by bone marrow flow cytometry and receptor gene rearrangement (TCR/IGH) testing (and if PET-CT is available, it must not indicate elevated bone marrow metabolism); Refractory or relapsed after at least first-line therapy, including, but not limited to, the following peripheral T-cell lymphomas:
Key exclusion criteria (17 listed)
- Those who have a history of allergy to any component of cell products.
- Grade II-IV. acute GVHD determined by Glucksberg criteria or grade B-D severity determined by IBMTR index; Patients with acute or chronic GVHD who required systemic treatment within four weeks prior to enrollment.
- Subjects who have been injected with live vaccines within 4 weeks before enrollment.
- Central nervous system diseases that are not related to lymphoma central invasion (such as brain aneurysm, epilepsy, stroke, Alzheimer's, psychosis, etc.). Lymphoma central invasion or gastrointestinal invasion is not used as an exclusion criterion, but enrollment is at the discretion of the investigator.
- Serious active infection (except uncomplicated urinary tract infection, bacterial pharyngitis), or currently receiving intravenous antibiotic therapy. However, prophylactic antibiotic, antiviral, and antifungal treatment for infections is allowed.
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 |
|---|---|---|
| Fully human CD5 chimeric antigen receptor T cell injectionCA5 CART cells were reinfused | Drug | Fully human CD5 chimeric antigen receptor T cell injection |
Primary outcome
Main objectives
Time frame: one month
To evaluate the safety of CD5 chimeric antigen receptor T cell injection (CD5CART) in the treatment of subjects with relapsed and refractory CD5 hematological tumors, and to explore the maximum tolerated dose (MTD).
6 secondary outcomes
ORR
Time frame: weeks 4 and 12 after CAR-T infusion
Time to Response (TTR)
Time frame: in 2 years post CAR-T infusion
Best overall response rate (BOR)
Time frame: within 3 months post CAR-T infusion
Duration of response (DOR)
Time frame: Minimum of 2 years post CAR-T infusion
Progression-free Survival (PFS)
Time frame: Minimum of 2 years post CAR-T infusion
Overall survival (OS)
Time frame: Minimum of 2 years post CAR-T infusion
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 30 Jun 2026.
- 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.
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully human CD5 chimeric antigen receptor T cell injection in people with Relapsed and Refractory CD5 Hematological Tumors, run by Institute of Hematology & Blood Diseases Hospital, China 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 16 inclusion and 17 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 30 Jun 2026. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main objectives (time frame: one month). 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 30 Jun 2026.