NCT06735495 CD19 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed/Refractory B Cell Hematologic Tumors
| NCT ID | NCT06735495 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | B-Cell Lymphoblastic Leukemia/Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2024-11-04 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multi-center, open, prospective single-arm clinical study of patients with relapsed / refractory B cell hematological tumors to evaluate the safety and efficacy of CD19 \& CD22 bispecific CAR-T cells in relapsed / refractory B cell hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.
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
Contact & Investigator
Heng Mei, M.D., Ph.D
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06735495 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 75 Years, studying B-Cell Lymphoblastic Leukemia/Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06735495 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06735495 currently recruiting?
Yes, NCT06735495 is actively recruiting participants. Contact the research team at hmei@hust.edu.cn for enrollment information.
Where is the NCT06735495 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06735495 clinical trial?
NCT06735495 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The principal investigator is Heng Mei, M.D., Ph.D at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 80 participants.
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