NCT06570915: T-ALL-2024

Daratumumab for T Cell ALL With MRD-positive After Standard Chemotherapy

Not yet recruiting Phase 2 Last updated 1 October 2025

What this trial tests

Phase 2 trial testing Daratumumab Injection in ALL, Adult in 20 participants. Not yet recruiting.

Timeline

1 December 2025

Primary endpoint
1 September 2027

1 September 2028

Quick facts

Lead sponsor	Institute of Hematology & Blood Diseases Hospital, China
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 December 2025
Primary completion	1 September 2027
Estimated completion	1 September 2028

Drugs / interventions tested

• Daratumumab Injection — full drug profile →

Conditions studied

• ALL, Adult — all drugs for ALL, Adult →

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Who can join

18 and older, any sex, with ALL, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

T-ALL accounts for about 15%-25% of Ph-negative ALL, and its clinical prognosis is worse than B-ALL. The successful application of immunotherapy has brought revolutionary progress to the treatment of ALL. But progress in the treatment of T-ALL has been relatively slow. Minimal residual disease (MRD) is a strong prognostic indicator for ALL patients. MRD-positive after induction therapy predicts a high risk of relapse. The National Comprehensive Cancer Network (NCCN) considers MRD-positive ALL patients to be at high risk. Research in the B-ALL field has demonstrated that immunotherapy has the potential to further clear MRD, which in turn translates into survival benefits. Daratumumab is a humanized, anti-CD38 IgG1 monoclonal antibody that binds to CD38 expressed by tumor cells. Apoptosis of tumor cells is induced through a variety of immune-related mechanisms such as complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cytophagocytosis (ADCP), and FCγ receptors, which are currently mainly used in the treatment of multiple myeloma. CD38 is highly and stably expressed on the surface of T-ALL cells, and its expression was less influenced by the previous treatment. Preliminary data from the clinical study of daratumumab combined with BFM bone frame prescription for the treatment of recurrent refractory T ALL(NCT03384654) showed that the effectiveness rate (ORR) was 83.3% in children and 60% in young adults. Compared with the previous historical data, the safety and tolerability were significantly improved. For T-ALL patients who relapse after allogeneic transplantation and achieve CR with intense chemotherapy but continue to have MRD-positive flow rate, daratumumab monotherapy can further clear MRD and achieve the purpose of sustaining CR. These studies all demonstrate the potential role of daratumumab in the treatment of T-ALL. Based on the current difficulties in the treatment of T-ALL and existing research data, we plan to conduct a prospective, single-arm, open-label phase II clinical study to explore the efficacy and safety of daratumumab for flow minimal residual disease positive T-ALL after standard chemotherapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adapting measurable residual disease evaluation to clinical practice for patients with acute lymphoblastic leukemia who underwent allogeneic stem cell transplantation.
   Chen Y, Li S, Zhao X, Chang Y. · · 2025 · PMID 41229975 · DOI 10.21147/j.issn.1000-9604.2025.05.02