NCT03125577 Combination CAR-T Cell Therapy Targeting Hematological Malignancies
| NCT ID | NCT03125577 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | B-cell Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-12-31 |
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 100 participants in total. It began in 2025-08-01 with a primary completion date of 2028-12-31.
⚠ 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
The study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
Eligibility Criteria
Inclusion Criteria: 1. age older than 6 months. 2. malignant B cell surface expression of CD19/CD20/CD22/CD30/CD38/CD70/CD123 molecules. 3. the KPS score over 80 points, and survival time is more than 1 month. 4. greater than Hgb 80 g/L. 5. no contraindications to blood cell collection. Exclusion Criteria: 1. accompanied with other active diseases, the treatment is difficult to assess patient response. 2. bacteria, fungus, or virus infection, unable to control. 3. living with HIV. 4. active HBV and HCV infection. 5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CAR-T treatment.
Contact & Investigator
Lung-Ji Chang, PhD
PRINCIPAL INVESTIGATOR
Shenzhen Geno-Immune Medical Institute
Frequently Asked Questions
Who can join the NCT03125577 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 75 Years, studying B-cell Malignancies. 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 NCT03125577 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 NCT03125577 currently recruiting?
Yes, NCT03125577 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT03125577 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Shenzhen, China, Kunming, China.
Who is sponsoring the NCT03125577 clinical trial?
NCT03125577 is sponsored by Shenzhen Geno-Immune Medical Institute. The principal investigator is Lung-Ji Chang, PhD at Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 100 participants.