A Phase 1/2 interventional study of Pediatric-Inspired Chemotherapy Regimen in T-ALL, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Withdrawn. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 1/2, Interventional, and Treatment
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.
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.
152 studies on the registry are indexed under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; 64 are open to participants now.
Browse Precursor T-Cell Lymphoblastic Leukemia-Lymphoma studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.
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Total bilirubin ≤1.5 × upper limit of normal (ULN) for the corresponding age group.
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.
Exclusion Criteria:
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as:
Active cardiac disease, defined as any of the following:
300mg D5,12；600mg D19,26
Drug: Pediatric-Inspired Chemotherapy Regimen
600mg D5,12；1200mg D19,26
Drug: Pediatric-Inspired Chemotherapy Regimen
1200 mg on Days 5, 12, 19, 26
Drug: Pediatric-Inspired Chemotherapy Regimen
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.
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.
Time frame: 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
Time frame: Up to approximately eight weeks
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.
Time frame: 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
Time frame: 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
Time frame: up to 2 years after the date of the last enrolled participants
Relapse free survival
This outcome analyzes patients achieved CR after therapy.
Time frame: up to 2 years after the date of the last enrolled participants
Event-free survival (EFS)
This outcome analyzes patients who received the therapy.
Time frame: 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
Time frame: up to 2 years after therapy
30-day mortality
Percentage of patients who died within 30 days from enrollment
Time frame: within 30 days from the start of the trial
60-day mortality
Percentage of patients who died within 60 days from enrollment
Time frame: within 60 days from the start of the trial
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Institute of Hematology & Blood Diseases Hospital, China