NCT06752785 CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.
| NCT ID | NCT06752785 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Guangzhou Women and Children's Medical Center |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 10 participants in total. It began in 2024-10-01 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
In this study, CD19/CD22 dual-target CAR-T therapy will be carried out among children patients who are still positive after induction remission, and subsequent chemotherapy will continue after CAR-T cells exert their functions. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19/CD22 to treat MRD-positive ALL. The CAR-T cells were provided by Shenzhen Cell Valley. The results of the research team from Stanford University School of Medicine in the United States have already demonstrated the feasibility and safety of producing bispecific CD19/CD22.BB.z-CAR T cells in a closed system as well as the high clinical activity shown in the treatment of CAR19-resistant B-ALL (B-lineage acute lymphoblastic leukemia) and LBCL (Large B-cell lymphoma). The investigators look forward to expanding the application of CAR-T cells in MRD positive B-ALL through this clinical study on safety and efficacy and greatly improving the prognosis of children patients with this type of B-ALL.
Eligibility Criteria
Inclusion Criteria: 1. Parents or legal guardians fully understand, are informed of this study and sign the informed consent form (ICF); are willing to follow and can complete all test procedures. 2. Chinese children aged 1-18 years old at the time of screening, regardless of gender, with a body weight ≥ 10 kg. 3. Bone marrow examination confirms that MRD is still positive on the 46th day after induction remission. 4. Tumor cells in the bone marrow (BM) or peripheral blood (PB) express CD19/CD22 within 3 months before screening. 5. Good organ function, which needs to meet the following criteria: (1)ALT ≤ 5 times the upper limit of normal value (ULN); (2)total bilirubin ≤ 2 times ULN (Gilbert's syndrome ≤ 3 times ULN); (3)without \> grade 1 dyspnea when not inhaling oxygen, and oxygen saturation \> 95%; (4)left ventricular ejection fraction (LVEF) ≥ 50%; (5)serum creatinine ≤ 1.5 times ULN. 6. Karnofsky score (≥ 16 years old) ≥ 70 or Lansky (\< 16 years old) score ≥ 50. 7. Expected survival period of at least 12 weeks. 8. Have sufficient venous access (for apheresis or venous blood sampling), and have no other contraindications for blood cell separation. Exclusion Criteria: 1. Have genetic diseases, except Down syndrome. 2. Have a history of other malignancies or have other malignancies simultaneously. 3. Meet any of the following conditions: (1)hepatitis B surface antigen (HBsAg) positive or HBV DNA quantification higher than the upper limit of normal value; (2)hepatitis C antibody (HCV Ab) positive and HCV RNA quantification higher than the upper limit of normal value; (3)human immunodeficiency virus antibody (HIV-Ab) positive; (4)Treponema pallidum antibody (TP-Ab) positive; (5)EBV DNA higher than the upper limit of normal value; (6)cytomegalovirus DNA higher than the upper limit of normal value. 4. Have or are suspected to have uncontrolled or require intravenous drug treatment for fungal, bacterial, viral or other infections. 5. Long-acting G-CSF is prohibited within 21 days before screening, and short-acting G-CSF is prohibited within 7 days before screening. 6. Have active central nervous system leukemia. 7. Are allergic to albumin and aminoglycoside antibiotics. 8. Have undergone organ transplantation (except hematopoietic stem cell transplantation). 9. Have participated in other interventional clinical studies within 3 months before screening (received active test drug treatment), or intend to participate in another clinical trial or receive anti-tumor treatment other than that specified in the protocol during the entire study period. 10. Cannot tolerate chemotherapy and cytokine storm due to impaired function of important organs. 11. Other situations that the investigator deems not suitable for participating in this clinical trial.
Contact & Investigator
Hua Jiang, phd
STUDY DIRECTOR
Guangzhou Women and Children's Medical Center
Frequently Asked Questions
Who can join the NCT06752785 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Acute Lymphoblastic Leukemia. 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 NCT06752785 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 NCT06752785 currently recruiting?
Yes, NCT06752785 is actively recruiting participants. Contact the research team at jiang_hua18@sina.cn for enrollment information.
Where is the NCT06752785 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06752785 clinical trial?
NCT06752785 is sponsored by Guangzhou Women and Children's Medical Center. The principal investigator is Hua Jiang, phd at Guangzhou Women and Children's Medical Center. The trial plans to enroll 10 participants.
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