Treatment of relapsed/refractory B cell tumors using bispecific CAR T cells

The Safety and Efficacy of CD19 & CD22 Bispecific CAR T Cells in Treating Relapsed / Refractory B Cell Hematological Tumors

This study is testing a new type of CAR T cell therapy that targets two specific proteins to see if it can help people with stubborn B cell tumors that haven't responded to other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 3 Years to 75 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: chemotherapy, CAR-T, chimeric antigen receptor
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06735495 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of CD19 & CD22 bispecific CAR T cells in patients with relapsed or refractory B cell hematologic tumors. It is a multi-center, open-label, single-arm study that aims to collect pharmacokinetics and pharmacodynamics data while treating participants. The dual-target CAR T cell therapy is designed to recognize both CD19 and CD22, potentially reducing the risk of target loss compared to single-target therapies. The study focuses on patients who have not responded to standard treatments and are in need of new therapeutic options.

Who should consider this trial

Good fit: Ideal candidates include patients with confirmed CD19+ or CD22+ relapsed or refractory B cell hematologic tumors.

Not a fit: Patients with B cell tumors that do not express CD19 or CD22 may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat B cell hematologic tumors.

How similar studies have performed: Other studies using CAR T cell therapies have shown promising results, indicating potential success for this dual-target approach.

Eligibility criteria

Inclusion Criteria:

1.CD 19 + / CD 22 + B cell hematological tumor was confirmed by pathological and histological examination, and the patient met the following criteria for relapsed or refractory B cell hematological tumor:

1. Refractory / relapsed B lymphocytic leukemia (1 of the following 4 items can be met):

   i . Recurrence within 6 months of first remission; ii. Primary refractory without complete remission after 2 cycles of standard chemotherapy regimen; iii. No complete remission or recurrence after first-line or multiline salvage chemotherapy; iv. Not eligible for HSCT conditions, abandonment of HSCT, or relapse after HSCT due to conditional limitations.
2. Refractory / relapsed B-cell lymphoma (meet the following item 1 of the first 4 items plus item 5):

i . After four courses of chemotherapy with a standard regimen, tumor shrinkage was less than 50% or disease progression; ii . CR after standard regimen chemotherapy, but relapsed within 6 months; iii.2 or more recurrences after CR; iv . Not suitable for hematopoietic stem cell transplantation, or abandoning HSCT due to conditional restrictions or relapse after hematopoietic stem cell transplantation; v . Subject must have received prior adequate treatment, including at least: a monoclonal antibody against CD 20 and combination chemotherapy containing an anthracycline drug agent.

2.The results of FCM or immunohistochemical detection of tumor antigen (CD 19 / CD 22) were positive.

3.The estimated survival period is more than 3 months starting from the signing of the informed consent form.

4.Good organ function,Meet the following requirements：

1. HGB≥70g/L(transfusible)
2. Liver and kidney function: creatinine ≤1.5XULN: total bilirubin ≤1.5XULN:ALT and AST≤2.5X ULN
3. Cardiopulmonary function: left ventricular ejection fraction \>50%; Blood oxygen saturation \>90%;

5.Subjects with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to 2.

Exclusion Criteria：(If meet any of the following criteria, patients will not be included)

1. Serious heart insufficiency,LVEF \<50%
2. History of severe pulmonary function impairment disease.
3. Other malignant tumors in the advanced stage.
4. Severe infection or persistent infection that cannot be effectively controlled.
5. Combined with severe autoimmune disease or innate immune deficiency.
6. Active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBV-DNA 500 IU / ml and abnormal liver function\] or hepatitis C antibody \[HCV-Ab\] positive, HCV-RNA above the lower limit of detection of the analytical method and abnormal liver function).
7. Human immunodeficiency virus (HIV) infection or syphilis infection.
8. History of severe allergies to biological products (including antibiotics).
9. Acute graft-versus-host response (GVHD) allogeneic hematopoietic stem remained one month after immunosuppressant discontinuation.
10. Patients who have other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the clinical trial or interfere with the study results, and who are deemed unsuitable for participation in the clinical trial by the investigator

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Heng Mei, M.D., Ph.D — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Heng Mei, M.D., Ph.D

Conditions B-Cell Lymphoblastic Leukemia/Lymphoma; CAR-T; dual-target; Relapsed / Refractory B Cell Hematological Tumors