T-ALLPhase 1/2NCT07585734
Clinical Trial of CD38 Monoclonal Antibody Combined With Chemotherapy for T-Cell Acute Lymphoblastic Leukemia
A Phase 1/2 study testing Pediatric-Inspired Chemotherapy Regimen in people with T-ALL, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
Acute Lymphoblastic Leukemia (ALL) is a group of common hematological malignancies characterized by high aggressiveness and heterogeneity. Over the past 50 years, outcomes for pediatric ALL have significantly improved, with approximately 90% of children achieving long-term survival. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- T-ALL
- What is being tested?
- Pediatric-Inspired Chemotherapy Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2025to 30 Apr 2027
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) according to the World Health Organization (WHO) 2022 classification or International Consensus Classification (ICC) criteria.
- Age ≥14 years, regardless of gender.
- CD38-positive expression on leukemic cells, confirmed by multicolor flow cytometry.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
- Laboratory parameters (assessed within 7 days prior to treatment):
- Total bilirubin ≤1.5 × upper limit of normal (ULN) for the corresponding age group.
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- AST and ALT ≤2.5 × ULN for the corresponding age group.
- Serum creatinine <2 × ULN for the corresponding age group.
- Cardiac enzymes <2 × ULN for the corresponding age group.
- Left ventricular ejection fraction (LVEF) >50%, measured by echocardiography (ECHO).
- Informed Consent Requirements:
- A written informed consent form must be signed prior to any study-specific procedures. The consent may be provided by the patient themselves, their legal guardian, or immediate family member. If obtaining consent directly from the patient is deemed clinically inappropriate or detrimental to the patient's treatment, consent must be obtained from the legal guardian or immediate family member.
Who cannot join
- Active central nervous system (CNS) leukemia or clinical manifestations of isolated extramedullary involvement of ALL.
- Relapsed/refractory patients (however, prior cytoreductive therapies such as hydroxyurea, corticosteroids, cyclophosphamide, or cytarabine are permitted).
- Chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) <60% of predicted value, confirmed by pulmonary function testing.
- Moderate to severe persistent asthma within the past 2 years, or uncontrolled asthma of any type at screening.
- Positive serology for human immunodeficiency virus (HIV).
- Positive syphilis serology.
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- Suspected or confirmed active tuberculosis (TB) infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as:
- Hepatitis B surface antigen (HBsAg)-positive;
- Hepatitis B core antibody (HBcAb)-positive with detectable HBV DNA;
- Anti-HCV antibody-positive with detectable HCV RNA.
- Concurrent malignancies of other organ systems requiring active therapy.
- Active cardiac disease, defined as any of the following:
- History of uncontrolled or symptomatic angina;
- Myocardial infarction within 6 months prior to study enrollment.
- History of arrhythmias requiring pharmacologic treatment or clinically significant arrhythmia;
- Uncontrolled or symptomatic congestive heart failure (CHF) > New York Heart Association (NYHA) Class II;
- Severe uncontrolled active infection.
- Psychiatric disorders that may compromise the patient's ability to complete treatment or provide informed consent.
- Any other condition deemed by the investigator to render the patient unsuitable for study participation.
About this study
Official title: A Phase I/II, Prospective, Single-Arm, Single-Center Clinical Trial of CD38 Monoclonal Antibody Combined With a Pediatric-Inspired Chemotherapy Regimen for Induction Therapy in Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia (ALL) is a group of common hematological malignancies characterized by high aggressiveness and heterogeneity. Over the past 50 years, outcomes for pediatric ALL have significantly improved, with approximately 90% of children achieving long-term survival. In adults, ALL accounts for 20%-30% of acute leukemias, and nearly two-thirds of adult ALL cases are Philadelphia chromosome-negative (Ph-negative). Based on immunophenotype, Ph-negative ALL can be further classified into B-cell ALL (B-ALL) and T-cell ALL (T-ALL). T-ALL constitutes 15%-25% of Ph-negative ALL cases and is associated with poorer clinical prognosis compared to B-ALL, including lower induction remission rates and a higher risk of relapse, even among patients who achieve complete remission (CR).
Over the past two decades, only nelarabine has been FDA-approved for relapsed/refractory T-ALL, but this drug is not available in China. Given the current therapeutic limitations, novel strategies to improve T-ALL outcomes are urgently needed.
Read more
CD38, a cell surface antigen highly and stably expressed on T-ALL cells with minimal influence from prior chemotherapy, has emerged as a promising therapeutic target. Preliminary clinical data for daratumumab, a CD38-targeted monoclonal antibody, demonstrate improved objective response rates (ORR) in pediatric and young adult patients compared to historical controls, along with favorable safety and tolerability.
CM313 injection (referred to as "CM313"), developed by Keymed Biosciences (Chengdu) Co., Ltd., is a humanized monoclonal antibody with proprietary intellectual property. Preclinical studies confirm that CM313 specifically binds to CD38 on the surface of hematologic tumor cells, including myeloma, lymphoma, and ALL. It exerts antitumor effects via multiple mechanisms: antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and Fc crosslinking-induced apoptosis. Additionally, CM313 inhibits CD38 ectoenzyme activity. In vitro and in vivo pharmacodynamic studies indicate comparable antitumor efficacy between CM313 and daratumumab. This study aims to evaluate the safety and efficacy of CM313 combined with pediatric-inspired chemotherapy regimens for induction therapy in adults with newly diagnosed T-ALL, providing a foundation for extending CD38 monoclonal antibody applications to T-ALL consolidation therapy.
Read the detailed description
This study is a prospective, single-arm, single-center phase I/II clinical trial. Eligible patients are adults newly diagnosed with T-cell acute lymphoblastic leukemia (T-ALL) according to the WHO (2022) or ICC classification criteria and deemed suitable for standard chemotherapy regimens.Study Design:Phase I (Dose-Escalation Stage):Utilizes a "3+3" dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of CM313 in combination with a pediatric-inspired chemotherapy regimen for T-ALL induction therapy. Determine the recommended phase II dose (RP2D) for subsequent evaluation.Phase II (Expansion Stage):Plans to enroll 20 T-ALL patients treated with the VDCLP regimen (vincristine, daunorubicin, cyclophosphamide, L-asparaginase, and prednisone) combined with CM313 at the RP2D during induction therapy.Subsequent treatment phases include:Consolidation therapy、Early Intensification 1st、Delayed Intensification 1st、Early Intensification 2nd、Delayed Intensification 2nd and Maintenance therapy.
- Conditions
- T-ALL
- Being tested
- Pediatric-Inspired Chemotherapy Regimen
- 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.
Pediatric-Inspired Chemotherapy RegimenDrug
Induction therapy regimen VDCLP(vincristine, daunorubicin, cyclophosphamide, L-asparaginase, and prednisone) combined with CM313 ；Subsequent treatment phases include:Consolidation therapy、Early Intensification 1st、Delayed Intensification 1st、Early Intensification 2nd、Delayed Intensification 2nd and Maintenance therapy.
| Study group | Role | What they receive |
|---|---|---|
| CM313 Level -1 | Experimental | 300mg D5,12；600mg D19,26 Receives: Drug: Pediatric-Inspired Chemotherapy Regimen |
| CM313 Level 0 | Experimental | 600mg D5,12；1200mg D19,26 Receives: Drug: Pediatric-Inspired Chemotherapy Regimen |
| CM313 Level 1 | Experimental | 1200 mg on Days 5, 12, 19, 26 Receives: Drug: Pediatric-Inspired Chemotherapy Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) of CM313 in combination with chemotherapy.
The CM313 combination chemotherapy regimen is divided into three dose levels: dose level -1, dose level 0, and dose level +1.
Measured: 6 weeks after induction therapy
MRD-negative complete remission (CR) rate by flow cytometry following induction therapy.
Among those who have achieved CR after induction therapy, proportion of patients who is MRD-negative
Measured: Up to approximately eight weeks
Secondary outcomes (8)
The ratio of Complete remission (CR)/CR with partial hematologic recovery (CRh)/CR with incomplete hematologic recovery (CRi)
The ratio of patients achieved CR/CRh/CRi after therapy.
Measured: Six weeks after therapy
Rate of conversion from MRD+to MRD- by Next-generation sequencing (NGS) after induction therapy
Next-generation sequencing (NGS) is a high-throughput sequencing methodology and is a process by which small fragments of DNA are sequenced in parallel multiple times
Measured: 30-days after induction therapy
overall survival
The interval from the date of enrollment to the date of death or the date of last follow-up, whichever occurred first
Measured: up to 2 years after the date of the last enrolled participants
Relapse free survival
This outcome analyzes patients achieved CR after therapy.
Measured: up to 2 years after the date of the last enrolled participants
Event-free survival (EFS)
This outcome analyzes patients who received the therapy.
Measured: up to 2 years after the date of the last enrolled participants
Cumulative incidence of relapse (CIR)
Cumulative incidence of relapse within 2 years post-treatment
Measured: up to 2 years after therapy
30-day mortality
Percentage of patients who died within 30 days from enrollment
Measured: within 30 days from the start of the trial
60-day mortality
Percentage of patients who died within 60 days from enrollment
Measured: within 60 days from the start of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start30 Apr 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Why it stopped: drug-associated adverse reactions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-ALLStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585734
- Sponsor's protocol ID
- IIT2025027
- Status last verified
- May 2026
- First submitted
- 17 Mar 2025
- Last updated
- 14 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Prospective, Single-Arm, Single-Center Clinical Trial of CD38 Monoclonal Antibody Combined With a Pediatric-Inspired Chemotherapy Regimen for Induction Therapy in Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07585734
- Acronym / sponsor ID
- IIT2025027
- Conditions
- T-ALL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: drug-associated adverse reactions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 May 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.
Acute Lymphoblastic Leukemia (ALL) is a group of common hematological malignancies characterized by high aggressiveness and heterogeneity. Over the past 50 years, outcomes for pediatric ALL have significantly improved, with approximately 90% of children achieving long-term survival. In adults, ALL accounts for 20%-30% of acute leukemias, and nearly two-thirds of adult ALL cases are Philadelphia chromosome-negative (Ph-negative). Based on immunophenotype, Ph-negative ALL can be further classified into B-cell ALL (B-ALL) and T-cell ALL (T-ALL). T-ALL constitutes 15%-25% of Ph-negative ALL cases and is associated with poorer clinical prognosis compared to B-ALL, including lower induction remission rates and a higher risk of relapse, even among patients who achieve complete remission (CR).
Over the past two decades, only nelarabine has been FDA-approved for relapsed/refractory T-ALL, but this drug is not available in China. Given the current therapeutic limitations, novel strategies to improve T-ALL outcomes are urgently needed.
CD38, a cell surface antigen highly and stably expressed on T-ALL cells with minimal influence from prior chemotherapy, has emerged as a promising therapeutic target. Preliminary clinical data for daratumumab, a CD38-targeted monoclonal antibody, demonstrate improved objective response rates (ORR) in pediatric and young adult patients compared to historical controls, along with favorable safety and tolerability.
CM313 injection (referred to as "CM313"), developed by Keymed Biosciences (Chengdu) Co., Ltd., is a humanized monoclonal antibody with proprietary intellectual property. Preclinical studies confirm that CM313 specifically binds to CD38 on the surface of hematologic tumor cells, including myeloma, lymphoma, and ALL. It exerts antitumor effects via multiple mechanisms: antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and Fc crosslinking-induced apoptosis. Additionally, CM313 inhibits CD38 ectoenzyme activity. In vitro and in vivo pharmacodynamic studies indicate comparable antitumor efficacy between CM313 and daratumumab. This study aims to evaluate the safety and efficacy of CM313 combined with pediatric-inspired chemotherapy regimens for induction therapy in adults with newly diagnosed T-ALL, providing a foundation for extending CD38 monoclonal antibody applications to T-ALL consolidation therapy.
Detailed description
This study is a prospective, single-arm, single-center phase I/II clinical trial. Eligible patients are adults newly diagnosed with T-cell acute lymphoblastic leukemia (T-ALL) according to the WHO (2022) or ICC classification criteria and deemed suitable for standard chemotherapy regimens.Study Design:Phase I (Dose-Escalation Stage):Utilizes a "3+3" dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of CM313 in combination with a pediatric-inspired chemotherapy regimen for T-ALL induction therapy. Determine the recommended phase II dose (RP2D) for subsequent evaluation.Phase II (Expansion Stage):Plans to enroll 20 T-ALL patients treated with the VDCLP regimen (vincristine, daunorubicin, cyclophosphamide, L-asparaginase, and prednisone) combined with CM313 at the RP2D during induction therapy.Subsequent treatment phases include:Consolidation therapy、Early Intensification 1st、Delayed Intensification 1st、Early Intensification 2nd、Delayed Intensification 2nd and Maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CM313 Level -1 | Experimental | Drug: Pediatric-Inspired Chemotherapy Regimen300mg D5,12；600mg D19,26 |
| CM313 Level 0 | Experimental | Drug: Pediatric-Inspired Chemotherapy Regimen600mg D5,12；1200mg D19,26 |
| CM313 Level 1 | Experimental | Drug: Pediatric-Inspired Chemotherapy Regimen1200 mg on Days 5, 12, 19, 26 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) according to the World Health Organization (WHO) 2022 classification or International Consensus Classification (ICC) criteria.
- Age ≥14 years, regardless of gender.
- CD38-positive expression on leukemic cells, confirmed by multicolor flow cytometry.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
- Laboratory parameters (assessed within 7 days prior to treatment):
Key exclusion criteria (20 listed)
- Active central nervous system (CNS) leukemia or clinical manifestations of isolated extramedullary involvement of ALL.
- Relapsed/refractory patients (however, prior cytoreductive therapies such as hydroxyurea, corticosteroids, cyclophosphamide, or cytarabine are permitted).
- Chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) <60% of predicted value, confirmed by pulmonary function testing.
- Moderate to severe persistent asthma within the past 2 years, or uncontrolled asthma of any type at screening.
- Positive serology for human immunodeficiency virus (HIV).
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 |
|---|---|---|
| Pediatric-Inspired Chemotherapy RegimenInduction therapy regimen VDCLP(vincristine, daunorubicin, cyclophosphamide, L-asparaginase, and prednisone) combined with CM313 ；Subsequent treatment phases include:Consolidation therapy、Early Intensification 1st、Delayed Intensification 1st、Early Intensification 2nd、Delayed Intensification 2nd and Maintenance therapy. | Drug | CM313 Level -1, CM313 Level 0, CM313 Level 1 |
Primary outcome
To determine the maximum tolerated dose (MTD) of CM313 in combination with chemotherapy.
Time frame: 6 weeks after induction therapy
The CM313 combination chemotherapy regimen is divided into three dose levels: dose level -1, dose level 0, and dose level +1.
MRD-negative complete remission (CR) rate by flow cytometry following induction therapy.
Time frame: Up to approximately eight weeks
Among those who have achieved CR after induction therapy, proportion of patients who is MRD-negative
8 secondary outcomes
The ratio of Complete remission (CR)/CR with partial hematologic recovery (CRh)/CR with incomplete hematologic recovery (CRi)
Time frame: Six weeks after therapy
Rate of conversion from MRD+to MRD- by Next-generation sequencing (NGS) after induction therapy
Time frame: 30-days after induction therapy
overall survival
Time frame: up to 2 years after the date of the last enrolled participants
Relapse free survival
Time frame: up to 2 years after the date of the last enrolled participants
Event-free survival (EFS)
Time frame: up to 2 years after the date of the last enrolled participants
Cumulative incidence of relapse (CIR)
Time frame: up to 2 years after therapy
30-day mortality
Time frame: within 30 days from the start of the trial
60-day mortality
Time frame: within 60 days from the start of the trial
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pediatric-Inspired Chemotherapy Regimen in people with T-ALL, run by Institute of Hematology & Blood Diseases Hospital, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 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: withdrawn, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
To determine the maximum tolerated dose (MTD) of CM313 in combination with chemotherapy. (time frame: 6 weeks after induction therapy). 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 14 May 2026.