Precursor T-Cell Lymphoblastic Leukemia-LymphomaPhase 1/2Phase I/IINCT06874946
Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/NHL
A Phase 1/2 study testing CD5-targeted CAR-T cells in people with Precursor T-Cell Lymphoblastic Leukemia-Lymphoma and T - Cell Lymphoma, run by Peking University People's Hospital at 1 site in China.
Trial summary
To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL/NHL Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, T - Cell Lymphoma, PTCL
- What is being tested?
- CD5-targeted CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2025to 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
- The subject or guardian understands and voluntarily signs the informed consent form (ICF).
- Male or female, aged 3-70 years at the time of signing the ICF (inclusive).
- Expected survival of at least 12 weeks.
- ECOG performance status of 0-2 at the time of ICF signing.
- Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia/lymphoma (R/R T-ALL/NHL) confirmed at screening and meeting at least one of the following criteria:
- Bone marrow involvement: Morphologic examination shows ≥5% lymphoblasts, and/or
Show all 17Show fewer
- Cerebrospinal fluid (CSF) involvement: Tumor cells detected in CSF, and/or
- Extramedullary disease: Presence of measurable lesions (lymph node/mass ≥1.5 cm in axial diameter or extranodal lesion ≥1 cm in axial diameter).
- CD5 expression: Tumor cells in bone marrow, peripheral blood, or CSF are CD5-positive by flow cytometry, and/or lymph node/mass or extranodal lesions are CD5-positive by pathology.
- Adequate major organ function, defined as:
- AST and ALT ≤5× upper limit of normal (ULN).
- Total bilirubin ≤2× ULN.
- Renal function: Serum creatinine clearance ≥60 mL/min (Cockcroft-Gault formula) or creatinine ≤1.5× ULN.
- Blood oxygen saturation >92%.
- Reproductive health requirements:
- Fertile men and women of childbearing potential must agree to use effective contraception from ICF signing until 2 years after study drug administration.
- Women of childbearing potential (pre-menopausal or within 2 years post-menopause) must have a negative blood pregnancy test at screening.
Who cannot join
- History of central nervous system (CNS) diseases, including but not limited to:
- Epilepsy
- Paralysis
- Aphasia
- Stroke
- Severe brain injury
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- Dementia
- Parkinson's disease
- Neuropathy
- History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:
- Crohn's disease
- Rheumatoid arthritis
- Systemic lupus erythematosus (SLE)
- Systemic sclerosis
- Inflammatory bowel disease (IBD)
- Vasculitis
- Psoriasis
- Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment.
- Positive virological or infectious disease markers, including:
- Hepatitis B virus (HBV): Subjects with positive HBsAg or HBcAb-positive at screening must have undetectable HBV DNA in peripheral blood to be eligible; otherwise, they should be excluded.
- Hepatitis C virus (HCV): Subjects with positive HCV antibodies and detectable HCV RNA should be excluded.
- Human immunodeficiency virus (HIV) antibody-positive subjects should be excluded.
- Cytomegalovirus (CMV) DNA test-positive subjects should be excluded.
- Epstein-Barr virus (EBV) DNA test-positive subjects should be excluded.
- Positive serological or non-specific antibodies for Treponema pallidum (syphilis).
- Clinically significant cardiovascular diseases, including any of the following:
- QTc interval ≥480 ms (Fridericia correction formula)
- New York Heart Association (NYHA) Class II or higher heart failure
- Unstable angina or acute myocardial infarction within 6 months prior to signing the ICF
- Left ventricular ejection fraction (LVEF) <50%
- Poorly controlled hypertension (as determined by the investigator)
- Clinically significant arrhythmias or those requiring antiarrhythmic treatment, including:
- Persistent ventricular tachycardia
- Ventricular fibrillation
- Torsades de pointes
- Complete left bundle branch block
- History of severe hypersensitivity or allergy to any components of the study drug.
- Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator).
- Receipt of extensive radiotherapy within 4 weeks prior to signing the ICF, except for palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study.
- Unresolved toxicity from prior antitumor therapy that has not returned to Grade 1 or baseline levels at the time of signing the ICF, except for hair loss and pigmentation (per NCI-CTCAE v5.0).
- Requirement for systemic corticosteroids or other immunosuppressive therapy (≥10 mg/day prednisone or equivalent) within 3 days prior to apheresis or during the study period, except for:
- Intranasal, inhaled, or topical steroids, or localized steroid injections (e.g., intra-articular injections)
- Systemic corticosteroids ≤10 mg/day prednisone (or equivalent physiological dose)
- Steroids as prophylaxis for allergic reactions (e.g., pre-medication before contrast-enhanced CT)
- Steroids used for symptomatic treatment of transfusion-related reactions
- Major surgery within 4 weeks prior to signing the ICF (excluding routine biopsy procedures) or planned major surgery during the study period.
- History of active tuberculosis infection within 1 year prior to signing the ICF, except for subjects with a history of tuberculosis more than 1 year ago, provided that the investigator determines there is no evidence of active tuberculosis.
- History of other primary malignancies within 5 years prior to signing the ICF, except for:
- Adequately treated carcinoma in situ of the cervix
- Localized basal cell carcinoma or squamous cell carcinoma of the skin
- Receipt of live-attenuated or inactivated vaccines within 4 weeks before signing the ICF or planned vaccination during the screening period.
- Any other condition or complication that, in the investigator's judgment, may affect adherence to the study protocol or make the subject unsuitable for participation.
- Pregnancy or lactation.
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
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiang-Yu Zhao, MD PhD, +861088324637, zhao_xy@bjmu.edu.cn
Xiang-Yu Zhao, MD PhD
About this study
Official title: A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD5-Targeted CAR-T Cells in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoma (T-ALL/NHL): The CONQUER Trial
To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL/NHL
Read the detailed description
This Phase I/II study aims to evaluate the safety, tolerability, and efficacy of Nanobody-Based CD5 Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma (T-NHL).
In the Phase I portion, a 3+3 dose-escalation design will be utilized to assess the safety profile and determine the optimal dose of Nanobody-Based CD5 CAR-T cells. The recommended Phase II dose (RP2D) will be established based on safety data, dose-limiting toxicities (DLTs), and preliminary efficacy outcomes.
The Phase II portion will then evaluate the efficacy of Nanobody-Based CD5 CAR-T therapy at the RP2D. The primary and secondary endpoints will include:
Overall response rate (ORR) Disease-free survival (DFS) Overall survival (OS) Comprehensive safety assessments will be conducted throughout the study, with a particular focus on cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
By investigating Nanobody-Based CD5 CAR-T therapy, this study aims to address the significant unmet clinical need for effective treatment options in patients with R/R T-ALL/NHL and provide insights into its potential as a novel immunotherapeutic approach.
- Being tested
- CD5-targeted CAR-T cells
- Keywords
- CD5, R/R T-ALL/LBL, R/R PTCL
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD5-targeted CAR-T cellsBiological
Phase I: Eligible patients will receive a single infusion of CD5-targeted CAR-T cells at one of three dose levels (0.5 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine and cyclophosphamide (FC) lymphodepleting chemotherapy. A 3+3 dose-escalation design will be used to determine the recommended Phase II dose (RP2D) based on safety, dose-limiting toxicities (DLTs), and preliminary efficacy.
Phase II: Patients will receive CD5-targeted CAR-T cells at the RP2D following FC lymphodepleting chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CD5-targeted CAR-T cells | Experimental | Eligible patients will receive a single infusion of CD5-targeted CAR-T cells at 3+3 dose-escalation design.
Phase II: Patients will receive CD5-targeted CAR-T cells at the RP2D. Receives: Biological: CD5-targeted CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT (Dose-Limiting Toxicity)
CRS and ICANS will be assessed per ASTCT (2019), while other AEs follow CTCAE v5.0. DLTs are CAR-T-related AEs that occur within 28 days post-infusion and meet the following criteria:
Grade 4+ CRS, or Grade 3 CRS unresolved to ≤ Grade 2 within 7 days. Grade 3+ non-hematologic toxicity unresolved to ≤ Grade 2 within 7 days. Grade 4+ ICANS, or Grade 3 ICANS unresolved to ≤ Grade 2 within 3 days. Grade 3+ hypersensitivity reaction. Any unexpected toxicity requiring study discontinuation.
Exemptions:
Rapid hypersensitivity resolving to ≤ Grade 2 in 2 hours. Reversible Grade 3 AEs lasting ≤7 days. Transient CRS-related organ dysfunction, resolving in ≤7 days per SRC.
All DLTs are reviewed by the Safety Review Committee (SRC).
Measured: Day28 after CAR-T cell infusion
Overall Response Rate (ORR)
ORR is defined as the proportion of patients achieving Complete Remission (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), or Morphologic Leukemia-Free State (MLFS) per European LeukemiaNet (ELN) 2022 for T-ALL and Lugano/Lyric 2016 for T-NHL.
CR: <5% blasts in bone marrow, no circulating blasts/extramedullary disease, ANC >1.0 × 10⁹/L, platelets >100 × 10⁹/L, MRD-negative.
CRi: Meets CR but lacks full hematologic recovery. MLFS: <5% blasts, no hematologic recovery required. Lugano 2016 (T-NHL): CR = complete metabolic response on PET-CT; PR = ≥50% tumor reduction.
Measured: Within 3 months after CAR-T cell infusion
Secondary outcomes (2)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the date of first documented Complete Remission (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), or Morphologic Leukemia-Free State (MLFS) until the date of bone marrow (BM) or peripheral blood (PB) relapse, extramedullary disease (EMD) progression, or death from any cause, whichever occurs first.
PFS will be assessed according to European LeukemiaNet (ELN) 2022 criteria for T-ALL and Lugano/Lyric 2016 criteria for T-NHL.
Measured: Within 2-year after CAR-T cell infusion
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of CD5-targeted CAR-T cell infusion until death from any cause. Patients alive at the time of analysis will be censored at the date of last follow-up.
Measured: Within 2-year 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 posted13 Mar 2025
- Study start14 Feb 2025
- Primary completion31 Dec 2026 (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 Precursor T-Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- anti CD5 CAR-T cells, eligible patients will be treated with CD5-targeted CAR-T cells.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Senlang Biotechnology Inc., Ltd.
- Responsible party
- Principal investigator, Xiangyu Zhao, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874946
- Sponsor's protocol ID
- 2025PHD001-001
- Acronym
- Phase I/II
- Status last verified
- May 2026
- First submitted
- 8 Mar 2025
- Last updated
- 7 May 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD5-Targeted CAR-T Cells in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoma (T-ALL/NHL): The CONQUER Trial
- ClinicalTrials.gov ID
- NCT06874946
- Acronym / sponsor ID
- Phase I/II / 2025PHD001-001
- Keywords
- CD5, R/R T-ALL/LBL, R/R PTCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Hebei Senlang Biotechnology Inc., Ltd.
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Mar 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.
To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL/NHL
Detailed description
This Phase I/II study aims to evaluate the safety, tolerability, and efficacy of Nanobody-Based CD5 Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma (T-NHL).
In the Phase I portion, a 3+3 dose-escalation design will be utilized to assess the safety profile and determine the optimal dose of Nanobody-Based CD5 CAR-T cells. The recommended Phase II dose (RP2D) will be established based on safety data, dose-limiting toxicities (DLTs), and preliminary efficacy outcomes.
The Phase II portion will then evaluate the efficacy of Nanobody-Based CD5 CAR-T therapy at the RP2D. The primary and secondary endpoints will include:
Overall response rate (ORR) Disease-free survival (DFS) Overall survival (OS) Comprehensive safety assessments will be conducted throughout the study, with a particular focus on cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
By investigating Nanobody-Based CD5 CAR-T therapy, this study aims to address the significant unmet clinical need for effective treatment options in patients with R/R T-ALL/NHL and provide insights into its potential as a novel immunotherapeutic approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- anti CD5 CAR-T cells, eligible patients will be treated with CD5-targeted CAR-T cells.
| Arm | Type | Receives |
|---|---|---|
| CD5-targeted CAR-T cells | Experimental | Biological: CD5-targeted CAR-T cellsEligible patients will receive a single infusion of CD5-targeted CAR-T cells at 3+3 dose-escalation design. Phase II: Patients will receive CD5-targeted CAR-T cells at the RP2D. |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- The subject or guardian understands and voluntarily signs the informed consent form (ICF).
- Male or female, aged 3-70 years at the time of signing the ICF (inclusive).
- Expected survival of at least 12 weeks.
- ECOG performance status of 0-2 at the time of ICF signing.
- Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia/lymphoma (R/R T-ALL/NHL) confirmed at screening and meeting at least one of the following criteria:
Key exclusion criteria (53 listed)
- History of central nervous system (CNS) diseases, including but not limited to:
- History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:
- Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment.
- Positive virological or infectious disease markers, including:
- Clinically significant cardiovascular diseases, including any of the following:
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 |
|---|---|---|
| CD5-targeted CAR-T cellsPhase I: Eligible patients will receive a single infusion of CD5-targeted CAR-T cells at one of three dose levels (0.5 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine and cyclophosphamide (FC) lymphodepleting chemotherapy. A 3+3 dose-escalation design will be used to determine the recommended Phase II dose (RP2D) based on safety, dose-limiting toxicities (DLTs), and preliminary efficacy. Phase II: Patients will receive CD5-targeted CAR-T cells at the RP2D following FC lymphodepleting chemotherapy. | Biological | CD5-targeted CAR-T cells |
Primary outcome
DLT (Dose-Limiting Toxicity)
Time frame: Day28 after CAR-T cell infusion
CRS and ICANS will be assessed per ASTCT (2019), while other AEs follow CTCAE v5.0. DLTs are CAR-T-related AEs that occur within 28 days post-infusion and meet the following criteria: Grade 4+ CRS, or Grade 3 CRS unresolved to ≤ Grade 2 within 7 days. Grade 3+ non-hematologic toxicity unresolved to ≤ Grade 2 within 7 days. Grade 4+ ICANS, or Grade 3 ICANS unresolved to ≤ Grade 2 within 3 days. Grade 3+ hypersensitivity reaction. Any unexpected toxicity requiring study discontinuation. Exemptions: Rapid hypersensitivity resolving to ≤ Grade 2 in 2 hours. Reversible Grade 3 AEs lasting ≤7 days. Transient CRS-related organ dysfunction, resolving in ≤7 days per SRC. All DLTs are reviewed by the Safety Review Committee (SRC).
Overall Response Rate (ORR)
Time frame: Within 3 months after CAR-T cell infusion
ORR is defined as the proportion of patients achieving Complete Remission (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), or Morphologic Leukemia-Free State (MLFS) per European LeukemiaNet (ELN) 2022 for T-ALL and Lugano/Lyric 2016 for T-NHL. CR: <5% blasts in bone marrow, no circulating blasts/extramedullary disease, ANC >1.0 × 10⁹/L, platelets >100 × 10⁹/L, MRD-negative. CRi: Meets CR but lacks full hematologic recovery. MLFS: <5% blasts, no hematologic recovery required. Lugano 2016 (T-NHL): CR = complete metabolic response on PET-CT; PR = ≥50% tumor reduction.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Within 2-year after CAR-T cell infusion
Overall Survival (OS)
Time frame: Within 2-year after 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 7 May 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.
1 site 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 CD5-targeted CAR-T cells in people with Precursor T-Cell Lymphoblastic Leukemia-Lymphoma and T - Cell Lymphoma, run by Peking University People's Hospital 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 17 inclusion and 53 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 7 May 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?
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 MENG LV, MD PhD (+861088324637, drlvmeng@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (Dose-Limiting Toxicity) (time frame: Day28 after CAR-T cell 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 7 May 2026.