Relapsed/Refractory T-lymphoblastic Leukemia/LymphomaPhase 1NCT07350863
U69-CART-Cells For R/R T-ALL
A Phase 1 study testing CXCR4 CCR9 CAR-T in people with Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Overall Introduction This single-arm, open-label clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection (CXCR4 CCR9 CAR-T) in patients with relapsed or refractory T-lymphoblastic leukemia/lymphoma (r/r… Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
- What is being tested?
- CXCR4 CCR9 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2026to 15 Jul 2028
- Phase
- Phase 1
- 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 15 to 75 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 eligible for the study:
- Informed Consent: Voluntary provision of written informed consent and anticipated ability to complete all required study procedures and follow-up assessments.
- Age: ≥15 and ≤75 years of age at the time of signing the informed consent form.For minors (age ≤ 18 years), informed consent must be provided by a legal guardian; minors with capacity to sign should co-sign the consent form alongside their guardian.
- Diagnosis and Disease Status: Histologically or cytologically confirmed diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL) according to the 2022 WHO Classification of Haematolymphoid Tumours, for which standard curative treatments are no longer effective.
- 3.1 For T-ALL: Presence of ≥5% blasts in bone marrow or peripheral blood at screening. Relapse: Defined as recurrence of blasts (≥5%) in peripheral blood or bone marrow or emergence of extramedullary disease after prior achievement of complete remission (CR/CRi). This includes early relapse (within 12 months of first remission), late relapse (≥12 months) failing to achieve remission after one multi-agent re-induction chemotherapy cycle, or relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT).
- Refractory: Defined as failure to achieve CR after at least two cycles of induction chemotherapy, or failure to achieve CR after one cycle of salvage therapy following relapse.
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- 3.2 For T-LBL: Presence of at least one measurable lesion at screening, defined as a nodal lesion with a long axis >15 mm or an extranodal lesion with a long axis >10 mm, as assessed by CT or MRI per the 2014 Lugano criteria.
- Relapsed/Refractory: Defined as relapse or disease progression after at least two prior lines of therapy; primary refractory disease (failure to achieve at least a partial response, PR, after first-line therapy); or relapse/progression after autologous or allogeneic HSCT (must be confirmed by tissue biopsy).
- Biomarker: Confirmed CCR9 positivity on tumor cells via flow cytometry of bone marrow samples and/or via immunohistochemistry of extramedullary lesion biopsies at screening.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life Expectancy: Estimated life expectancy of greater than 3 months.
- Bone Marrow Reserve: Adequate bone marrow reserve at screening, defined as:
- Absolute Neutrophil Count (ANC) ≥ 1.0 × 10⁹/L Absolute Lymphocyte Count (ALC) ≥ 0.3 × 10⁹/L Platelet Count (PLT) ≥ 20 × 10⁹/L (transfusion support is permitted).
- Organ Function: Adequate organ function defined as:
- Hepatic: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 × Upper Limit of Normal (ULN); Total Bilirubin ≤ 2 × ULN.
- Renal: Serum Creatinine ≤ 1.5 × ULN, OR Creatinine Clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula).
- Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 45%. Pulmonary: Oxygen saturation ≥ 92% on room air.
- Contraception: Female subjects of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective contraception for at least one year post-infusion. Male subjects with female partners of childbearing potential must agree to use barrier contraception and refrain from sperm donation for at least one year post-infusion.
- Leukapheresis: Must have adequate venous access for leukapheresis or venous blood draw and no other contraindications to leukapheresis.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- Diagnosis of any other malignancy within 3 years prior to screening, except for those who have completed curative therapy and achieved over 3 years of disease-free survival with a low risk of recurrence as determined by the investigator (e.g., carcinoma in situ of the lung, basal cell carcinoma of the skin).
- History or presence of central nervous system (CNS) disorders unrelated to the disease under study at screening or previously, such as seizure, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS.
- Prior receipt of cell therapies targeting CCR9, including but not limited to CAR-T or CAR-γδT cells.
- Significant or active parenchymal CNS or cranial nerve lesions where, in the investigator's judgment, the risks outweigh the benefits.
- Systemic corticosteroid use discontinued ≤72 hours prior to apheresis, except for physiological replacement doses (e.g., prednisone <10 mg/day or equivalent).
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- Donor lymphocyte infusion (DLI) within 6 weeks prior to apheresis.
- Treatment with any anti-T-cell antibody therapy within 4 weeks prior to apheresis.
- Presence of any of the following: positive hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) with HBV-DNA above the lower limit of quantification; positive hepatitis C antibody (HCV-Ab) with HCV-RNA above the lower limit of quantification; positive treponema pallidum antibody (TP-Ab); positive human immunodeficiency virus (HIV) antibody test; or EBV-DNA or CMV-DNA levels above the lower limit of quantification by quantitative PCR.
- Active or uncontrolled infection requiring systemic therapy at the time of screening (excluding mild genitourinary or upper respiratory tract infections), as assessed by the investigator.
- Coronary angioplasty or stent placement within 12 months prior to informed consent; congestive heart failure of New York Heart Association (NYHA) Class III-IV; myocardial infarction, unstable angina, or other clinically significant cardiac conditions within 6 months deemed ineligible by the investigator; QTc interval >480 ms (calculated using Fridericia's formula) at screening; or uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) or pulmonary hypertension despite standard treatment.
- Unstable systemic diseases per investigator judgment, including but not limited to severe hepatic, renal, or metabolic diseases requiring pharmacological intervention.
- Active or uncontrolled autoimmune disease, or primary/secondary immunodeficiency.
- History of severe immediate hypersensitivity to any drug used in the study.
- Administration of any live vaccine within 6 weeks prior to screening.
- Pregnant or lactating individuals.
- History of autoimmune disease requiring systemic immunosuppressive or disease-modifying medication within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
- Allogeneic hematopoietic stem cell transplantation within 12 weeks prior to apheresis; presence of acute or moderate-to-severe chronic GVHD within 4 weeks prior to screening; or any systemic GVHD treatment within 4 weeks prior to cell infusion, including those requiring concomitant corticosteroid use.
- Participation in any other interventional clinical trial within 4 weeks prior to screening.
- Inability to comply with study procedures, or any other condition considered by the investigator to render the subject unsuitable for the study.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Sheng-Li Xue, M.D., +8651267781139, slxue@suda.edu.cn
About this study
Official title: A Phase I, Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of U69 in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL)
Overall Introduction This single-arm, open-label clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection (CXCR4 CCR9 CAR-T) in patients with relapsed or refractory T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL). Additionally, the study seeks to preliminarily assess the efficacy of CXCR4 CCR9 CAR-T cells and explore the appropriate dosage and administration schedule for subsequent Phase II clinical trials. A dose escalation study following the 3+3 design was implemented across three dose cohorts, with each cohort planned to enroll 3 to 6 patients, totaling 9 to 18 participants. Following cell infusion, subjects underwent safety and efficacy follow-up, which continued until 2 years post-infusion, subject withdrawal, or study termination-whichever occurred first. For subjects with available follow-up information after study completion or early termination, long-term follow-up-including long-term safety monitoring-was conducted for up to 15 years.
- Being tested
- CXCR4 CCR9 CAR-T
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXCR4 CCR9 CAR-TDrug
CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection solution
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | The investigational product is the CXCR4-enhanced CCR9 Chimeric Antigen Receptor T-Cell Injection (CXCR4/CCR9 CAR-T, U69). The planned doses per cohort are:
Low Dose Cohort: 1 × 10⁶ CAR-positive T cells per kg of body weight. The product is administered as a single intravenous infusion. The actual administered dose is acceptable within a range of 70% to 130% of the target dose. The required cell number will be calculated based on the subject's body weight at the time of apheresis. The Investigator may adjust the final cell dose based on the subject's specific clinical condition. Receives: Drug: CXCR4 CCR9 CAR-T |
| Medium dose group | Experimental | The investigational product is the CXCR4-enhanced CCR9 Chimeric Antigen Receptor T-Cell Injection (CXCR4/CCR9 CAR-T, U69). The planned doses per cohort are:
Medium Dose Cohort: 3 × 10⁶ CAR-positive T cells per kg of body weight. The product is administered as a single intravenous infusion. The actual administered dose is acceptable within a range of 70% to 130% of the target dose. The required cell number will be calculated based on the subject's body weight at the time of apheresis. The Investigator may adjust the final cell dose based on the subject's specific clinical condition. Receives: Drug: CXCR4 CCR9 CAR-T |
| High dose group | Experimental | The investigational product is the CXCR4-enhanced CCR9 Chimeric Antigen Receptor T-Cell Injection (CXCR4/CCR9 CAR-T, U69). The planned doses per cohort are:
High Dose Cohort: 6 × 10⁶ CAR-positive T cells per kg of body weight. The product is administered as a single intravenous infusion. The actual administered dose is acceptable within a range of 70% to 130% of the target dose. The required cell number will be calculated based on the subject's body weight at the time of apheresis. The Investigator may adjust the final cell dose based on the subject's specific clinical condition. Receives: Drug: CXCR4 CCR9 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
DLT refers to any of the following conditions occurring within 28 days after cell reinfusion that are related to cell infusion:
① Hematologic DLT: Grade 4 toxicity (excluding lymphopenia) not caused by the underlying disease and taking more than 30 days to resolve to ≤ Grade 2.
② Non-hematologic DLT: Any toxicity ≥ Grade 4 that is possibly related to CAR-T therapy, or Grade 3 toxicity that requires ≥7 days to resolve to ≤ Grade 2 or to return to baseline.
Measured: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
Adverse Event (AE）
Record the types, occurrence frequency and severity of adverse events (AEs) related to CAR-T, with specific definitions determined according to CTCAE v5.0.The CRS and ICANS ratings do not use CTCAE but adopt the evaluation criteria in the ASTCT standards.
Measured: 2 years
The Recommended Phase II Dose（RP2D）
The dose recommended for use in phase 2 studies on the basis of dose limiting toxicities observed in phase 1 studies.
Measured: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
Secondary outcomes (13)
Objective Response Rate (ORR)
Defined as the proportion of subjects achieving an objective response (complete or partial response). All subjects not meeting the objective response criteria as of the data cutoff date will be considered non-responders.
①For T-ALL patients: Treatment response is defined as the achievement of either Complete Remission (CR) or Complete Remission with Incomplete Hematologic Recovery (CRi);
②For T-LBL patients: Treatment response is defined as the achievement of either Complete Response (CR) or Partial Response (PR);
Measured: 28 days and within 3 months after infusion of CXCR4 CCR9 CAR-T cells
MRD-negative rate (for T-ALL)
The proportion of T-ALL patients with negative MRD in the bone marrow when the therapeutic effect reaches remission. T-ALL patients have residual leukemia cells in the bone marrow detected by flow cytometry below 10-⁴ and/or negative qualitative or quantitative detection of bone marrow fusion genes (if any).
Measured: 28 days and within 3 months after infusion of CXCR4 CCR9 CAR-T cells
Duration of Response (DOR)
It refers to the period from the time when the subject first achieves remission to the time of disease progression or death due to the disease. Subjects who have not experienced disease progression or death by the time of the final data collection will be censored at the time of their last valid tumor assessment. Common reasons for censoring include, but are not limited to:
- Loss to follow-up; ②Withdrawal from the study; ③Initiation of a new anticancer therapy.
Measured: 2 years
Progression-Free Survival (PFS)
Defined as the time from the date of cell infusion to the date of first documented disease progression or death from any cause, whichever occurs first. Subjects who have not experienced disease progression or death by the data cutoff date will be censored at the time of their last tumor assessment.
Measured: 2 years
Event-Free Survival (EFS)
Defined as the time from the date of cell infusion to the occurrence of any of the following events (whichever comes first):
- Death from any cause after achieving remission ②Disease relapse or progression ③Treatment failure, defined as either lack of efficacy or discontinuation of the clinical trial due to:
- Death
- Adverse events
- Lack of efficacy or disease progression
- Initiation of new antitumor therapy
Measured: 2 years
Overall Survival (OS)
Defined as the time from the date of cell infusion to the date of death from any cause. For subjects who are still alive at the time of analysis, OS will be censored on the date of last known contact. It is specifically noted that subsequent allogeneic hematopoietic stem cell transplantation or receipt of any new antitumor therapy will not constitute a censoring event for OS analysis.
Measured: 2 years
Pharmacokinetics-AUC(0-28)
The area under the curve from 0 to 28 days for the reinfusion.
Measured: 2 years
Pharmacokinetics-Cmax
The peak concentration of the drug in the peripheral blood sample.
Measured: 2 years
Pharmacokinetics-Tmax
The time at which the peak concentration of the drug is reached in the peripheral blood sample.
Measured: 2 years
IL-6
Changes in the levels of IL-6.
Measured: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
IFNγ
Changes in the levels of IFNγ.
Measured: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
Ferritin
Changes in the levels of Ferritin.
Measured: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
C-reactive protein(CRP)
Changes in the levels of CRP.
Measured: Within 28 days after CXCR4 CCR9 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 posted20 Jan 2026
- Study start25 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory T-lymphoblastic Leukemia/LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350863
- Sponsor's protocol ID
- SZRTALL02
- Status last verified
- Sep 2026
- First submitted
- 23 Dec 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline characteristics of patients, outcomes
Publications
Li YR, Zhu Y, Chen Y, Yang L. The clinical landscape of CAR-engineered unconventional T cells. Trends Cancer. 2025 Jun;11(6):520-539. doi: 10.1016/j.trecan.2025.03.001. Epub 2025 Mar 27.
PubMed 40155286Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.
PubMed 30592986Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
PubMed 25113753
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of U69 in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL)
- ClinicalTrials.gov ID
- NCT07350863
- Acronym / sponsor ID
- SZRTALL02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 20 Jan 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.
Overall Introduction This single-arm, open-label clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection (CXCR4 CCR9 CAR-T) in patients with relapsed or refractory T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL). Additionally, the study seeks to preliminarily assess the efficacy of CXCR4 CCR9 CAR-T cells and explore the appropriate dosage and administration schedule for subsequent Phase II clinical trials. A dose escalation study following the 3+3 design was implemented across three dose cohorts, with each cohort planned to enroll 3 to 6 patients, totaling 9 to 18 participants. Following cell infusion, subjects underwent safety and efficacy follow-up, which continued until 2 years post-infusion, subject withdrawal, or study termination-whichever occurred first. For subjects with available follow-up information after study completion or early termination, long-term follow-up-including long-term safety monitoring-was conducted for up to 15 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: CXCR4 CCR9 CAR-TThe investigational product is the CXCR4-enhanced CCR9 Chimeric Antigen Receptor T-Cell Injection (CXCR4/CCR9 CAR-T, U69). The planned doses per cohort are: Low Dose Cohort: 1 × 10⁶ CAR-positive T cells per kg of body weight. The product is administered as a single intravenous infusion. The actual administered dose is acceptable within a range of 70% to 130% of the target dose. The required cell number will be calculated based on the subject's body weight at the time of apheresis. The Investigator may adjust the final cell dose based on the subject's specific clinical condition. |
| Medium dose group | Experimental | Drug: CXCR4 CCR9 CAR-TThe investigational product is the CXCR4-enhanced CCR9 Chimeric Antigen Receptor T-Cell Injection (CXCR4/CCR9 CAR-T, U69). The planned doses per cohort are: Medium Dose Cohort: 3 × 10⁶ CAR-positive T cells per kg of body weight. The product is administered as a single intravenous infusion. The actual administered dose is acceptable within a range of 70% to 130% of the target dose. The required cell number will be calculated based on the subject's body weight at the time of apheresis. The Investigator may adjust the final cell dose based on the subject's specific clinical condition. |
| High dose group | Experimental | Drug: CXCR4 CCR9 CAR-TThe investigational product is the CXCR4-enhanced CCR9 Chimeric Antigen Receptor T-Cell Injection (CXCR4/CCR9 CAR-T, U69). The planned doses per cohort are: High Dose Cohort: 6 × 10⁶ CAR-positive T cells per kg of body weight. The product is administered as a single intravenous infusion. The actual administered dose is acceptable within a range of 70% to 130% of the target dose. The required cell number will be calculated based on the subject's body weight at the time of apheresis. The Investigator may adjust the final cell dose based on the subject's specific clinical condition. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects must meet all of the following criteria to be eligible for the study:
- 3.1 For T-ALL: Presence of ≥5% blasts in bone marrow or peripheral blood at screening. Relapse: Defined as recurrence of blasts (≥5%) in peripheral blood or bone marrow or emergence of extramedullary disease after prior achievement of complete remission (CR/CRi). This includes early relapse (within 12 months of first remission), late relapse (≥12 months) failing to achieve remission after one multi-agent re-induction chemotherapy cycle, or relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT).
- Refractory: Defined as failure to achieve CR after at least two cycles of induction chemotherapy, or failure to achieve CR after one cycle of salvage therapy following relapse.
- 3.2 For T-LBL: Presence of at least one measurable lesion at screening, defined as a nodal lesion with a long axis >15 mm or an extranodal lesion with a long axis >10 mm, as assessed by CT or MRI per the 2014 Lugano criteria.
- Relapsed/Refractory: Defined as relapse or disease progression after at least two prior lines of therapy; primary refractory disease (failure to achieve at least a partial response, PR, after first-line therapy); or relapse/progression after autologous or allogeneic HSCT (must be confirmed by tissue biopsy).
Key exclusion criteria (20 listed)
- Subjects will be excluded from the study if they meet any of the following criteria:
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 |
|---|---|---|
| CXCR4 CCR9 CAR-TCXCR4-enabled CCR9 chimeric antigen receptor T-cell injection solution | Drug | High dose group, Low-dose group, Medium dose group |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
DLT refers to any of the following conditions occurring within 28 days after cell reinfusion that are related to cell infusion: ① Hematologic DLT: Grade 4 toxicity (excluding lymphopenia) not caused by the underlying disease and taking more than 30 days to resolve to ≤ Grade 2. ② Non-hematologic DLT: Any toxicity ≥ Grade 4 that is possibly related to CAR-T therapy, or Grade 3 toxicity that requires ≥7 days to resolve to ≤ Grade 2 or to return to baseline.
Adverse Event (AE）
Time frame: 2 years
Record the types, occurrence frequency and severity of adverse events (AEs) related to CAR-T, with specific definitions determined according to CTCAE v5.0.The CRS and ICANS ratings do not use CTCAE but adopt the evaluation criteria in the ASTCT standards.
The Recommended Phase II Dose（RP2D）
Time frame: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
The dose recommended for use in phase 2 studies on the basis of dose limiting toxicities observed in phase 1 studies.
13 secondary outcomes
Objective Response Rate (ORR)
Time frame: 28 days and within 3 months after infusion of CXCR4 CCR9 CAR-T cells
MRD-negative rate (for T-ALL)
Time frame: 28 days and within 3 months after infusion of CXCR4 CCR9 CAR-T cells
Duration of Response (DOR)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Event-Free Survival (EFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Pharmacokinetics-AUC(0-28)
Time frame: 2 years
Pharmacokinetics-Cmax
Time frame: 2 years
Pharmacokinetics-Tmax
Time frame: 2 years
IL-6
Time frame: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
IFNγ
Time frame: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
Ferritin
Time frame: Within 28 days after CXCR4 CCR9 CAR-T cell infusion
C-reactive protein(CRP)
Time frame: Within 28 days after CXCR4 CCR9 CAR-T cell 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 2 Sep 2026.
- Background: PubMed 40155286Li YR, Zhu Y, Chen Y, Yang L. The clinical landscape of CAR-engineered unconventional T cells. Trends Cancer. 2025 Jun;11(6):520-539. doi: 10.1016/j.trecan.2025.03.001. Epub 2025 Mar 27.
- Background: PubMed 30592986Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.
- Background: PubMed 25113753Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
- Individual participant dataSharing planned: Yes. Baseline characteristics of patients, outcomes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CXCR4 CCR9 CAR-T in people with Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma, run by The First Affiliated Hospital of Soochow University 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 19 inclusion and 20 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 2 Sep 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 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.
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 Sheng-Li Xue, M.D. (008651267781139, slxue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Within 28 days after CXCR4 CCR9 CAR-T cell 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 NCT07350863, which also lists 3 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 2 Sep 2026.