T-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT06316427
Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies
A Phase 1/2 study testing Autologous CD7 CAR T-cell, Prior-HSCT donor-derived CD7 CAR T-cell and New donor-derived CD7 CAR T-cell in people with T-cell Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Beijing GoBroad Hospital at 4 sites in China.
Trial summary
This is a multi-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell malignancies will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia
- What is being tested?
- Autologous CD7 CAR T-cell, Prior-HSCT donor-derived CD7 CAR T-cell and New donor-derived CD7 CAR T-cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesChina
- Study dates
- 22 Mar 2024to 30 Mar 2028
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only patients who meet all the following criteria can be included in the group:
- CD7-positive refractory or relapsed T-cell malignancies with progression or intolerance after all standard treatments, limited prognosis from currently available treatments and no available treatment options (e.g. HSCT or chemotherapy).
- Tumor cells in bone marrow or cerebrospinal fluid are positive for CD7 antigen by flow cytometry or tumour tissue is positive for CD7 by immunohistochemistry (CD7 antigen positivity by flow cytometry: >80% of tumour cells expressing CD7 with a mean fluorescence intensity [MFI] of CD7 similar to that of normal T cells are considered to have fully positive expression; >80% of tumor cells expressing CD7 but with an MFI of CD7 at least 1 log lower than that of normal T cells are considered to have low expression [dim]; tumor cells with a CD7 expression rate between 20-80% are considered to have partial expression; CD7 antigen positivity by pathological immunohistochemistry: >30%);
- Male or female, age 1-70 years;
- No severe allergic constitution;
- Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al., 1982) of 0-2;
- Life expectancy of at least 60 days as determined by the investigator;
- Provide a signed informed consent form prior to any screening procedures; subjects volunteering to participate in the study should be capable of understanding and signing the informed consent form and be willing to follow the study visit schedule and associated study procedures as specified in the protocol. Subjects aged 19-70 years old need to be sufficiently aware and capable of signing the informed consent form; subjects aged 1-7 years can be recruited after legal guardians or patient advocates sign the informed consent form; subjects aged 8-18 years need to be sufficiently aware and able to sign the informed consent form, and their legal guardians or patient advocates also need to sign the informed consent form.
Who cannot join
- Patients with at least one of the following conditions are excluded:
- Intracranial hypertension or unconscious;
- Acute heart failure or severe arrhythmia;
- Acute respiratory failure;
- Other types of malignant tumors;
- Diffuse intravascular coagulation;
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- Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value;
- Sepsis or other uncontrolled infection;
- Uncontrolled diabetes mellitus;
- Severe psychological disorder;
- Obvious cranial lesions by cranial MRI;
- Allergic constitution;
- Organ recipients;
- Pregnant or breastfeeding;
- Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206
- Not yet recruiting
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan, 610083
- Recruiting
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, 200435
- Recruiting
Shanghai Liquan Hospital
Shanghai, Shanghai Municipality, 201418
About this study
Official title: Autologous and Donor-derived CD7 CAR T-cell Therapy in Refractory or Relapsed T-cell Malignancies: a Multi-center, Open-label, Phase Ⅰ/Ⅱ Clinical Trial
This is a multi-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell malignancies will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled.
- Conditions
- T-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia, T-cell Malignancies
- Being tested
- Autologous CD7 CAR T-cell, Prior-HSCT donor-derived CD7 CAR T-cell, New donor-derived CD7 CAR T-cell
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CD7 CAR T-cellDrug
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from patients.
Prior-HSCT donor-derived CD7 CAR T-cellDrug
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from prior-HSCT donors.
New donor-derived CD7 CAR T-cellDrug
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from new donors.
| Study group | Role | What they receive |
|---|---|---|
| Arm-1 | Experimental | Autologous CD7 CAR T-cell treatment Receives: Drug: Autologous CD7 CAR T-cell |
| Arm-2 | Experimental | Prior-HSCT donor-derived CD7 CAR T-cell treatment Receives: Drug: Prior-HSCT donor-derived CD7 CAR T-cell |
| Arm-3 | Experimental | New donor-derived CD7 CAR T-cell treatment Receives: Drug: New donor-derived CD7 CAR T-cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT) in phase I
Type and incidence of dose-limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion
Measured: 21 days post infusion
Overall Response Rate (ORR) in phase II
Overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease per National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Measured: 3 months (± 1 week) post infusion
Secondary outcomes (9)
Overall Response Rate (ORR) in phase I
Overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease per National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Measured: 3 months (± 1 week) post infusion
Safety in phase II
The adverse events in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus.
Measured: 2 years post infusion
Progression-Free Survival (PFS) in phase II
Progression-free survival (PFS) in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells.
Measured: 2 years post infusion
Duration of Remission (DOR) in phase II
Duration of remission (DOR) in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells.
Measured: 2 years post infusion
Overall Survival (OS) in phase II
Overall survival (OS) in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells.
Measured: 2 years post infusion
Levels of CD7 CAR-T Cells in phase II
Levels of CD7 CAR-T cells in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Measured: 2 years post infusion
Levels of CAR transgene in phase II
Levels of CAR transgene in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Measured: 2 years post infusion
Levels of immune cells in phase II
Levels of immune cells in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Measured: 2 years post infusion
Levels of cytokines in phase II
Levels of cytokines in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
Measured: 2 years post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start22 Mar 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Mar 2028 (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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Investigator Initiate Trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The General Hospital of Western Theater Command, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Liquan Hospital, Central People's Hospital of Zhanjiang, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Jing Pan, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316427
- Sponsor's protocol ID
- BJGBYY-IIT-LCYJ-2024-003
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous and Donor-derived CD7 CAR T-cell Therapy in Refractory or Relapsed T-cell Malignancies: a Multi-center, Open-label, Phase Ⅰ/Ⅱ Clinical Trial
- ClinicalTrials.gov ID
- NCT06316427
- Acronym / sponsor ID
- BJGBYY-IIT-LCYJ-2024-003
- Conditions
- T-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia, T-cell Malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- The General Hospital of Western Theater Command, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Liquan Hospital, Central People's Hospital of Zhanjiang, First Affiliated Hospital of Guangxi Medical University
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 18 Mar 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.
This is a multi-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell malignancies will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Investigator Initiate Trial
| Arm | Type | Receives |
|---|---|---|
| Arm-1 | Experimental | Drug: Autologous CD7 CAR T-cellAutologous CD7 CAR T-cell treatment |
| Arm-2 | Experimental | Drug: Prior-HSCT donor-derived CD7 CAR T-cellPrior-HSCT donor-derived CD7 CAR T-cell treatment |
| Arm-3 | Experimental | Drug: New donor-derived CD7 CAR T-cellNew donor-derived CD7 CAR T-cell treatment |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- CD7-positive refractory or relapsed T-cell malignancies with progression or intolerance after all standard treatments, limited prognosis from currently available treatments and no available treatment options (e.g. HSCT or chemotherapy).
- Tumor cells in bone marrow or cerebrospinal fluid are positive for CD7 antigen by flow cytometry or tumour tissue is positive for CD7 by immunohistochemistry (CD7 antigen positivity by flow cytometry: >80% of tumour cells expressing CD7 with a mean fluorescence intensity [MFI] of CD7 similar to that of normal T cells are considered to have fully positive expression; >80% of tumor cells expressing CD7 but with an MFI of CD7 at least 1 log lower than that of normal T cells are considered to have low expression [dim]; tumor cells with a CD7 expression rate between 20-80% are considered to have partial expression; CD7 antigen positivity by pathological immunohistochemistry: >30%);
- Male or female, age 1-70 years;
- No severe allergic constitution;
- Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al., 1982) of 0-2;
Key exclusion criteria (15 listed)
- Intracranial hypertension or unconscious;
- Acute heart failure or severe arrhythmia;
- Acute respiratory failure;
- Other types of malignant tumors;
- Diffuse intravascular coagulation;
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 CD7 CAR T-cellPeripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from patients. | Drug | Arm-1 |
| Prior-HSCT donor-derived CD7 CAR T-cellPeripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from prior-HSCT donors. | Drug | Arm-2 |
| New donor-derived CD7 CAR T-cellPeripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from new donors. | Drug | Arm-3 |
Primary outcome
Dose-Limiting Toxicity (DLT) in phase I
Time frame: 21 days post infusion
Type and incidence of dose-limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion
Overall Response Rate (ORR) in phase II
Time frame: 3 months (± 1 week) post infusion
Overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease per National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells
9 secondary outcomes
Overall Response Rate (ORR) in phase I
Time frame: 3 months (± 1 week) post infusion
Safety in phase II
Time frame: 2 years post infusion
Progression-Free Survival (PFS) in phase II
Time frame: 2 years post infusion
Duration of Remission (DOR) in phase II
Time frame: 2 years post infusion
Overall Survival (OS) in phase II
Time frame: 2 years post infusion
Levels of CD7 CAR-T Cells in phase II
Time frame: 2 years post infusion
Levels of CAR transgene in phase II
Time frame: 2 years post infusion
Levels of immune cells in phase II
Time frame: 2 years post infusion
Levels of cytokines in phase II
Time frame: 2 years post 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 26 Nov 2025.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous CD7 CAR T-cell, Prior-HSCT donor-derived CD7 CAR T-cell and New donor-derived CD7 CAR T-cell in people with T-cell Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Beijing GoBroad Hospital at 4 sites 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 8 inclusion and 15 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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 zhuojun ling (86+18611422920, lingzj@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) in phase I (time frame: 21 days post 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?
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 26 Nov 2025.