Trials / Unknown
UnknownNCT05070156
B010-A Injection for Treating Patients With GPC3 Positive Advanced Hepatocellular Carcinoma
A Phase 1 Open-label, Single Arm Study Targeting Glypican-3 (GPC3) Chimeric Antigen Receptor Modified T Cells (CAR-T) for Treatment of Advanced Hepatocellular Carcinoma
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Tongji University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is an Open-label, Single Arm study to observe the safety and tolerability of B010-A in the treatment of advanced hepatocellular carcinoma.
Detailed description
All subjects participating in this study will receive peripheral blood mononuclear cell collection to produce B010-A injection products after enrollment. Subjects may receive bridging anti-cancer therapy while waiting for the production of B010-A injection. All subjects need to undergo baseline assessment before receiving cell infusion. For all subjects, the baseline assessment includes weight, body surface area, vital signs, physical examination, ECOG score, laboratory examination, coagulation function, etiological examination, 12-lead ECG, echocardiogram, cytokine testing, Tumor marker detection and ICE score, etc. Each subject will receive lymphodepletion prior to B010-A infusion, and dose-limiting toxicity (DLT) assessment will be performed on D28 after the first infusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Biological/Vaccine: Low-dose group | 1.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition. |
| BIOLOGICAL | Biological/Vaccine: Mid-dose group | 2.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition. |
| BIOLOGICAL | Biological/Vaccine: High-dose group | 3.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition. |
Timeline
- Start date
- 2021-10-29
- Primary completion
- 2024-08-31
- Completion
- 2024-09-30
- First posted
- 2021-10-07
- Last updated
- 2023-12-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05070156. Inclusion in this directory is not an endorsement.