NCT05388695 To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors
| NCT ID | NCT05388695 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hebei Senlang Biotechnology Inc., Ltd. |
| Condition | 19 and 22+ B Cell Hematologic Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-04-08 |
| Primary Completion | 2027-03-30 |
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 100 participants in total. It began in 2022-04-08 with a primary completion date of 2027-03-30.
⚠ 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
To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).
Eligibility Criteria
Inclusion Criteria: 1. Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL); 2. CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old; 4.Estimated survival time\>3 months; 5.ECOG Scores: 0\~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF\>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent. Exclusion Criteria: 1. With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease; 2. Presence of other malignant tumors; 3. There are severe infections that cannot be effectively controlled; 4. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood; 5. Known positive serology for human immunodeficiency virus (HIV) or syphilis; 6. A history of severe allergies to biological products (including antibiotics); 7. Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD); 8. Female patients who are under pregnancy and/or lactation; 9. Active autoimmune disease requiring systemic immunosuppressive therapy; 10. Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.
Contact & Investigator
Jia Wei, PhD&MD
PRINCIPAL INVESTIGATOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT05388695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying 19 and 22+ B Cell Hematologic Tumors. 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 NCT05388695 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 NCT05388695 currently recruiting?
Yes, NCT05388695 is actively recruiting participants. Contact the research team at jiawei@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT05388695 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05388695 clinical trial?
NCT05388695 is sponsored by Hebei Senlang Biotechnology Inc., Ltd.. The principal investigator is Jia Wei, PhD&MD at Tongji Hospital. The trial plans to enroll 100 participants.