T-Cell Acute Lymphoblastic LeukemiaPhase 1/2NCT07678307
A Multicenter, Open-label, Non-randomized, Single-arm Phase 1/2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma
A Phase 1/2 study testing Autologous nano CD5-CAR T Cells in people with T-Cell Acute Lymphoblastic Leukemia and T-Lymphoblastic Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This is a clinical research study for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma. The study will test a new treatment called "autologous nano CD5-CAR T cells". These are your own immune cells that have been changed in a lab to recognize and kill cancer cells. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- T-Cell Acute Lymphoblastic Leukemia, T-Lymphoblastic Lymphoma, Relapsed/Refractory Hematologic Malignancies
- What is being tested?
- Autologous nano CD5-CAR T Cells
- 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
- 30 Jun 2026to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 3 to 70 years old
- Diagnosed with CD5-positive relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)
- ECOG performance status 0-2
- Adequate organ function (renal, hepatic, cardiac, pulmonary)
- Able to understand and sign informed consent
Who cannot join
- Active severe infection or uncontrolled sepsis
- History of allogeneic stem cell transplantation within 3 months
- Severe autoimmune disease or immunodeficiency
- Prior CD5-targeted therapy
- Pregnant or breastfeeding women
- Any condition that, in the investigator's opinion, would compromise safety or compliance with the protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase 1/2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma
This is a clinical research study for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma.
The study will test a new treatment called "autologous nano CD5-CAR T cells". These are your own immune cells that have been changed in a lab to recognize and kill cancer cells.
Read more
This study has two parts: Phase 1 to test the safety and best dose of the treatment, and Phase 2 to see how well it works.
You may receive the study treatment if you meet all the eligibility criteria. The main things the study will look at are: how safe the treatment is, how many people's cancer goes away or gets better, and how long the effect lasts.
Possible risks include fever, low blood pressure, and infection, which the study team will monitor closely.
Read the detailed description
This is a multicenter, open-label, non-randomized, single-arm Phase 1/2 study evaluating the safety and efficacy of autologous nano CD5-CAR T cells in adult and adolescent patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) who have failed prior standard therapies.
The Phase 1 portion uses a dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The Phase 2 portion will enroll patients at the RP2D to evaluate the overall response rate (ORR) per independent review committee (IRC) assessment.
Secondary objectives include assessment of duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety profile including adverse events (AEs) of special interest such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Key inclusion criteria include confirmed diagnosis of r/r T-ALL/T-LBL, adequate organ function, and measurable disease. Key exclusion criteria include active severe infection, prior allogeneic stem cell transplantation within 100 days, and known central nervous system involvement that is not controlled.
The study will enroll approximately [X] patients at multiple investigational sites in China. All patients will receive lymphodepleting chemotherapy followed by infusion of autologous nano CD5-CAR T cells. Safety assessments will be performed throughout the study period, including regular laboratory tests and clinical evaluations.
- Conditions
- T-Cell Acute Lymphoblastic Leukemia, T-Lymphoblastic Lymphoma, Relapsed/Refractory Hematologic Malignancies
- Being tested
- Autologous nano CD5-CAR T Cells
- Keywords
- CD5-CAR-T Cell Therapy, Nano CAR-T, Relapsed Refractory T-ALL, Relapsed Refractory T-Lymphoblastic Lymphoma, Phase 1/2 Clinical Trial, Hematologic Malignancies
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous nano CD5-CAR T CellsBiological
Autologous CD5-targeted CAR-T cells engineered with a novel nano antibody-based chimeric antigen receptor. Patients receive lymphodepleting chemotherapy (fludarabine 30 mg/m²/day + cyclophosphamide 250 mg/m²/day for 3 days) followed by a single intravenous infusion of CAR-T cells. The study uses a dose-escalation design with two main dose levels: 1.0×10^6 cells/kg and 2.0×10^6 cells/kg, with a backup low dose of 0.5×10^6 cells/kg for use in case of insufficient cell yield.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Nano CD5-CAR T Cells for Relapsed/Refractory T-ALL/LBL | Experimental | All enrolled patients will receive lymphodepleting chemotherapy with fludarabine (30 mg/m²/day for 3 days) and cyclophosphamide (250 mg/m²/day for 3 days), followed by a single intravenous infusion of autologous nano CD5-CAR T cells. The study uses a dose-escalation design with two main dose levels: 1.0×10^6 cells/kg and 2.0×10^6 cells/kg, with a backup low dose of 0.5×10^6 cells/kg. Receives: Biological: Autologous nano CD5-CAR T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLT)
Proportion of patients experiencing dose-limiting toxicities (DLT) within 28 days after CAR-T infusion, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
Measured: 28 days 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 posted1 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678307
- Sponsor's protocol ID
- IIT2026011
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase 1/2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT07678307
- Acronym / sponsor ID
- IIT2026011
- Conditions
- T-Cell Acute Lymphoblastic Leukemia, T-Lymphoblastic Lymphoma, Relapsed/Refractory Hematologic Malignancies
- Keywords
- CD5-CAR-T Cell Therapy, Nano CAR-T, Relapsed Refractory T-ALL, Relapsed Refractory T-Lymphoblastic Lymphoma, Phase 1/2 Clinical Trial, Hematologic Malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jul 2026 (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 a clinical research study for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma.
The study will test a new treatment called "autologous nano CD5-CAR T cells". These are your own immune cells that have been changed in a lab to recognize and kill cancer cells.
This study has two parts: Phase 1 to test the safety and best dose of the treatment, and Phase 2 to see how well it works.
You may receive the study treatment if you meet all the eligibility criteria. The main things the study will look at are: how safe the treatment is, how many people's cancer goes away or gets better, and how long the effect lasts.
Possible risks include fever, low blood pressure, and infection, which the study team will monitor closely.
Detailed description
This is a multicenter, open-label, non-randomized, single-arm Phase 1/2 study evaluating the safety and efficacy of autologous nano CD5-CAR T cells in adult and adolescent patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) who have failed prior standard therapies.
The Phase 1 portion uses a dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The Phase 2 portion will enroll patients at the RP2D to evaluate the overall response rate (ORR) per independent review committee (IRC) assessment.
Secondary objectives include assessment of duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety profile including adverse events (AEs) of special interest such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Key inclusion criteria include confirmed diagnosis of r/r T-ALL/T-LBL, adequate organ function, and measurable disease. Key exclusion criteria include active severe infection, prior allogeneic stem cell transplantation within 100 days, and known central nervous system involvement that is not controlled.
The study will enroll approximately [X] patients at multiple investigational sites in China. All patients will receive lymphodepleting chemotherapy followed by infusion of autologous nano CD5-CAR T cells. Safety assessments will be performed throughout the study period, including regular laboratory tests and clinical evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Nano CD5-CAR T Cells for Relapsed/Refractory T-ALL/LBL | Experimental | Biological: Autologous nano CD5-CAR T CellsAll enrolled patients will receive lymphodepleting chemotherapy with fludarabine (30 mg/m²/day for 3 days) and cyclophosphamide (250 mg/m²/day for 3 days), followed by a single intravenous infusion of autologous nano CD5-CAR T cells. The study uses a dose-escalation design with two main dose levels: 1.0×10^6 cells/kg and 2.0×10^6 cells/kg, with a backup low dose of 0.5×10^6 cells/kg. |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 3 to 70 years old
- Diagnosed with CD5-positive relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)
- ECOG performance status 0-2
- Adequate organ function (renal, hepatic, cardiac, pulmonary)
- Able to understand and sign informed consent
Key exclusion criteria (6 listed)
- Active severe infection or uncontrolled sepsis
- History of allogeneic stem cell transplantation within 3 months
- Severe autoimmune disease or immunodeficiency
- Prior CD5-targeted therapy
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Autologous nano CD5-CAR T CellsAutologous CD5-targeted CAR-T cells engineered with a novel nano antibody-based chimeric antigen receptor. Patients receive lymphodepleting chemotherapy (fludarabine 30 mg/m²/day + cyclophosphamide 250 mg/m²/day for 3 days) followed by a single intravenous infusion of CAR-T cells. The study uses a dose-escalation design with two main dose levels: 1.0×10^6 cells/kg and 2.0×10^6 cells/kg, with a backup low dose of 0.5×10^6 cells/kg for use in case of insufficient cell yield. | Biological | Autologous Nano CD5-CAR T Cells for Relapsed/Refractory T-ALL/LBL |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLT)
Time frame: 28 days after CAR-T cell infusion
Proportion of patients experiencing dose-limiting toxicities (DLT) within 28 days after CAR-T infusion, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
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 1 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous nano CD5-CAR T Cells in people with T-Cell Acute Lymphoblastic Leukemia and T-Lymphoblastic Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, 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 6 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 1 Jul 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact liang Huang (+86 022-23608126, huangliang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLT) (time frame: 28 days after CAR-T cell infusion). 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 1 Jul 2026.