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Clinical Trial of CD38 Monoclonal Antibody Combined With Chemotherapy for T-Cell Acute Lymphoblastic Leukemia

NCT07585734 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2026-05-14

No results posted yet for this study

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. 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.

Conditions

  • T-ALL

Interventions

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-04-30
Completion
2027-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585734 on ClinicalTrials.gov