A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia

NCT07190261 | Not Yet Recruiting Phase 2

• 1 other identifier: BCMA/CD3+--R/R wAIHA
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Glucocorticoids are the first-line treatment for wAIHA, but patients are prone to recurrence after dose reduction or discontinuation of glucocorticoids. Birgens et al. 's study found that approximately 55% of patients treated with prednisolone monotherapy experienced recurrence at 36 months. The overall response rate of second-line treatment with rituximab is 70-80%, but the recurrence rate reaches 50%. The response rates of other immunosuppressants, such as cyclosporine, cyclophosphamide, and azathioprine, are relatively low, approximately 30-50%. Patients with chronic hemolysis have recurrent episodes, which affect their survival and quality of life. New treatment methods need to be explored.

Conditions

Autoimmune Hemolytic Anemia

Keywords

Autoimmune Hemolytic Anemia; Enatumab; Single-arm phase 2 prospective

Outcome Measures

Primary Outcomes (1)

• overall response rate (ORR)

  The overall response rate (ORR) and complete response rate (CRR) at 3 months. The overall response rate (ORR) is defined as the ratio of patients achieving complete response (CR) plus partial response (PR)

  3 months

Secondary Outcomes (1)

• The incidence and severity of adverse events

  6-months

Study Arms (1)

Enatumab treat

EXPERIMENTAL

The recommended subcutaneous injection dose of this product is as follows: an incremental dose of 12mg on day 1, an incremental dose of 32mg on day 4, an initial treatment dose of 38mg on day 8, and subsequent treatment doses of 38mg in weeks 4 and 6.

Drug: enatumab

Interventions

enatumab DRUG

The recommended subcutaneous injection dose of this product is as follows: an incremental dose of 12mg on day 1, an incremental dose of 32mg on day 4, an initial treatment dose of 38mg on day 8, and subsequent treatment doses of 38mg in weeks 4 and 6.

Enatumab treat

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, gender not limited.
• Primary wAIHA with a clear diagnosis.
• Patients who have relapsed or are refractory after at least second-line treatment (previous treatments include at least two types of glucocorticoids, CD20 monoclonal antibodies or other immunosuppressants). Refractory is defined as failure to achieve partial remission after 6 months of treatment with a stable dose of immunosuppressants.
• The infusion of CD20 monoclonal antibody should be at least three months apart. If taking immunosuppressants such as cyclosporine and sirolimus, the medication should be discontinued for at least one month.
• Hemoglobin (HGB) ≤100g/ and ≥ 60g/L.
• Before treatment, the patient's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 3 times the upper limit of normal (ULN), and the serum creatinine was less than 1.5 times ULN.
• Voluntarily join this study, sign the informed consent form with good compliance, and be willing to cooperate with regular follow-ups for efficacy evaluation and side effect monitoring.

You may not qualify if:

• (1) Those with impaired functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency.
• (2) Patients with connective tissue diseases and other secondary AIHA. (3) There is an active infection of hepatitis B virus (HBV), hepatitis C virus (HCV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), human immunodeficiency virus (HIV), or any uncontrolled bacterial, fungal or viral infection.
• (4) Complicated with malignant tumors or a history of tumors. (5) When screening, the subjects had other types of uncorrected anemia, such as nutritional anemia, etc.
• (6) Had received other BCMA-targeted or CART treatments before screening. (7) Pregnant or lactating women. (8) Activity ≥ grade 2 peripheral sensory/motor neuropathy. (9) Had received treatment with other experimental drugs within 30 days (or as required by local regulations) or within 5 half-lives (whichever is longer) prior to the first use of the intervention drug in this study.

Sponsors & Collaborators

• Bing Han: lead

Study Sites (1)

Peking union medical college hospital

Beijing, Shuangfuyuan, NO I., 100730, China

Location

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Peking Union Medical College Hospital

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): September 18, 2027
• Study Completion (Estimated): September 18, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 10years
• Access Criteria: email request

Locations

CN (1)