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T-Cell Acute Lymphocytic LeukemiaPhase 1/2NCT05909527

A Clinical Study of CAR-T Treating Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma

A Phase 1/2 study testing CD7 CAR-T in people with T-Cell Acute Lymphocytic Leukemia, run by Guangzhou Bio-gene Technology Co., Ltd at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is a single arm, non blind, randomized, single center study aimed at evaluating the safety, pharmacokinetic characteristics, and preliminary efficacy of CD7 CAR-T cell injection in r/r T-ALL/LBL subjects. Read more about this study

Who is it for?
Ages 2 to 60 years
Conditions the study is for
T-Cell Acute Lymphocytic Leukemia
What is being tested?
CD7 CAR-T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
1 May 2023to 1 Aug 2028
Phase
Phase 1/2
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 2 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • The patient or his/her guardian understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedure;
  • Age 2~60 (including threshold), regardless of gender;
  • According to the WHO 2016 standard, the patients with relapsed/refractory acute T-lymphoblastic leukemia/lymphoma (including early pre T-lymphoblastic leukemia) who failed to receive standard treatment or lacked effective treatment methods met any of the following criteria:
  • 1) Recurrence: disease recurrence is confirmed after receiving at least two treatment schemes to achieve complete remission in the past, or disease recurrence occurs after stem cell transplantation to achieve complete remission; 2) Difficult to treat: Have received at least two treatment schemes in the past, and failed to reach CR (for leukemia patients) or PR (for lymphoma patients) after the last treatment, or failed to get remission or develop disease after stem cell transplantation;
  • 4. During screening, the bone marrow examination was definitely diagnosed as CD7 positive by flow cytometry and/or the tumor was definitely diagnosed as CD7 positive by pathological immunohistochemistry, and the positive rate of CD7 was ≥ 70%;
  • 5. The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is less than grade 2 (unless the abnormality is related to the tumor or is judged to be stable by the researcher, which has little impact on the safety or efficacy);
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  • 6. The ECOG physical condition score is 0~2 and the expected life span is more than 3 months;
  • 7. With appropriate organ functions:
  • Glutamic alanine transaminase (ALT) and glutamic oxaloacetic transaminase (AST) ≤ 3 times the upper limit of normal value (ULN). The researcher judges that ALT and AST are abnormal due to diseases (such as liver infiltration or bile duct obstruction), and their indicators can be relaxed to ≤ 5 times ULN;
  • Total bilirubin ≤ 1.5 times ULN;
  • Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min;
  • Hemoglobin ≥ 70g/L or maintained at this level after blood transfusion;
  • Indoor oxygen saturation ≥ 92%;
  • Left ventricular ejection fraction (LVEF) ≥ 45%.

Who cannot join

  • When collecting and preparing CAR-T blood, those with a tumor load greater than 70%;
  • Have malignant tumors other than T-cell hematological malignancies within 5 years, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, breast ductal carcinoma in situ after radical resection cancer.
  • CNS leukemia patients with clinical symptoms.
  • Hepatitis B surface antigen (HBsAg) is positive, hepatitis B core antibody (HBcAb) is positive and the detection of hepatitis B virus (HBV) DNA titer in peripheral blood is not within the normal reference value range; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Positive individuals for cytomegalovirus (CMV) DNA testing; Syphilis test positive.
  • Those with a history of severe allergies or known any of the active ingredients, excipients or mouse-derived products contained in the drug, or those allergic to xenogeneic proteins in this trial, including lymphocyte depletion regimens. Severe allergy history is defined as an allergic reaction of grade two or above, and any of the following clinical manifestations occur when an allergic reaction occurs: airway obstruction (runny nose, cough, wheezing, dyspnea), hypercardia tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiration, cardiac arrest.
  • Severe heart disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (refractory Hypertension is defined as: on the basis of improving lifestyle, a reasonable tolerable and sufficient amount of ≥3 kinds of antihypertensive drugs (including diuretics) has been used for > 1 month and the blood pressure has not reached the standard, or the blood pressure can only be achieved effective control after taking ≥4 kinds of antihypertensive drugs.
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  • Have unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy.
  • Those who have received organ transplants or are about to receive organ transplants (except for hematopoietic stem cell transplants).
  • Patients with acute and chronic graft-versus-host disease (GVHD).
  • Patients who received hematopoietic stem cell transplantation within 6 months before screening and who have active GVHD after stopping Immunosuppressive drug therapy.
  • Active autoimmune or inflammatory diseases of the nervous system (eg, Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular disease (eg, cerebral edema) , Posterior Reversible Encephalopathy Syndrome (PRES)).
  • Those who have tumor emergencies (such as spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) before screening or reinfusion and need emergency treatment.
  • The presence of an uncontrolled bacterial, fungal, viral or other infection requiring antibiotic treatment.
  • Those who have undergone major surgical operations (except diagnostic surgery and biopsy) within 4 weeks before clearing the lymph cells, or those who plan to undergo major surgery during the study period, or those whose surgical wounds have not healed completely before enrollment.
  • Those who have received (attenuated) live virus vaccine within 4 weeks before screening.
  • Persons with severe mental illness.
  • Those who are alcoholics or have a history of drug abuse.
  • Pregnant or lactating women, female subjects who plan to become pregnant within 2 years after cell reinfusion, and male subjects whose partners plan to become pregnant within 2 years after cell reinfusion.
  • Patients with contraindications to any research procedure or with other medical conditions that may expose them to unacceptable risks at the discretion of the investigator and/or clinical criteria.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hebei Yanda Hospital

    Langfang, Hebei, 065000

Other trials in China

About this study

Official title: A Single-arm, Open-label, Single-center Clinical Study: Safety and Efficacy of Anti-CD7 CAR-T in the Treatment of Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma

This study is a single arm, non blind, randomized, single center study aimed at evaluating the safety, pharmacokinetic characteristics, and preliminary efficacy of CD7 CAR-T cell injection in r/r T-ALL/LBL subjects.

Read the detailed description

This study is a single dose escalation and dose extension study. The main purpose of the IIT clinical trial is to evaluate the safety, tolerance, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in r/r T-ALL/LBL subjects. The study includes two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B) of CD7 CAR-T cell injection. The study plans to enroll 30 subjects, of which approximately 12-18 are planned to be enrolled in the dose escalation phase, and the remaining are planned to be enrolled in the dose escalation phase.

Being tested
CD7 CAR-T
Keywords
T-ALL, CAR T-cell therapy, CD7
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD7 CAR-TBiological

    A single infusion of autologous CD7 CAR-T cells administered intravenously

Study groups in NCT05909527
Study groupRoleWhat they receive
Treatment groupExperimentalDose escalation: After enrollment ,Participants complete the PBMC apheresis, then complete the Lymphocyte clearance, and then receive the dose climming test: 0.50E6/kg±20%, 1.00E6/kg±20%、2.00E6/kg±20%. Dose Expansion: During or after the dose increase process, if a certain dose group is determined to have preliminary anti-tumor effects and controllable safety, it can be extended at this dose level to further evaluate the tolerance and safety of CD7 CAR-T injection, and to preliminarily evaluate its effectiveness.
Receives: Biological: CD7 CAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limited Toxicity, DLT

    After the infusion of CD7 CAR-T cells, subjects still experienced adverse events related to or possibly related to CD7 CAR-T cell infusion after optimal supportive treatment

    Measured: Up to 28 days after CD7 CAR-T infusion

  2. Maximal Tolerable Dose, MTD

    The highest dose for DLT in ≤ 1/6 subjects

    Measured: Up to 28 days after CD7 CAR-T infusion

  3. Incidence of Treatment-Emergent Adverse Events

    Count the Incidence of adverse events

    Measured: Up to 2 years after CD7 CAR-T infusion

Secondary outcomes (6)

  1. Complete Response Rate, CRR

    Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)

    Measured: Up to 2 years after CD7 CAR-T infusion

  2. Partial Remission Rate, PRR

    Proportion of subjects who achieved a partial response (PR)

    Measured: Up to 2 years after CD7 CAR-T infusion

  3. Relapse-Free Survival, RFS

    From remission to relapse or death of the subject (including all causes), whether the subject relapsed or died is unknown until the date of the last follow-up examination.

    Measured: Up to 2 years after CD7 CAR-T infusion

  4. Event Free Survival, EFS

    Counting from the beginning of cell transfusion until treatment failure, recurrence, or death (various causes). Subjects without any of these events were counted up to the last follow-up examination date. For patients without CR or CRi, EFS is calculated from the beginning of cell transfusion until disease progression or death. Based on the initial event.

    Measured: Up to 2 years after CD7 CAR-T infusion

  5. Concentration of Cytokine after Infusion

    Calculate the change of cytokine level in peripheral blood by flow cytometry after After CD7 CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ.

    Measured: Up to 2 years after CD7 CAR-T infusion

  6. Concentration of CAR-T cells after Infusion (PK)

    CAR-T in peripheral blood after infusion

    Measured: Up to 3 months of CAR-T cell infusion, CAR-T cells were not detected for 2 consecutive times.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Why it stopped: Due to corporate strategic adjustment.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05909527
Sponsor's protocol ID
BG-CT-22-004
Status last verified
Mar 2026
First submitted
9 Jun 2023
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD7 CAR-T in people with T-Cell Acute Lymphocytic Leukemia, run by Guangzhou Bio-gene Technology Co., Ltd 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 14 inclusion and 19 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: withdrawn, as of the sponsor's last update on 17 Mar 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.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limited Toxicity, DLT (time frame: Up to 28 days after CD7 CAR-T infusion). The study lists 3 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 NCT05909527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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