Trials / Unknown
UnknownNCT03302403
Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Kang YU · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR T cells in patients with malignant tumors with positive antigen targets. CAR T cells are genetically engineered to express single-chain variable fragment (scFv) targeting indication-specific antigens. The investigational CAR T cells and proposed indications are as follows: CAR-CD19 T cells for B cell leukaemia/lymphoma; CAR-BCMA T cells for myeloma; CAR-GPC3 T cell for hepatocellular carcinoma; CAR-CLD18 T cells for pancreatic carcinoma and adenocarcinoma of esophagogastric junction.
Detailed description
This study is designed to determine the safety, tolerability and engraftment potential of lentivirus-transduced CAR T cells in patients with malignant tumors. Primary objectives: 1. Determine the safety and tolerability of CAR T cells (autologous T cells transduced with chimeric antigen receptors recognizing CD19, BCMA, GPC3 and Claudin18.2) in patients with malignant tumors (B-cell lymphoblastic leukaemia/lymphoma, myeloma, hepatocellular carcinoma, pancreatic carcinoma and adenocarcinoma of esophagogastric junction). 2. Observe the cytokinetics of CAR T cells. Secondary objectives: 1. Observe the efficacy of CAR T cells in patients with malignant tumors. 2. Make an evaluation on the distribution and in vivo survival of CAR T cells in targeted tissues. 3. Observe the immunogenicity of CAR T cells, and determine if there are anti-scFv cellular immune response and anti-scFv humoral immune response. 4. Observe the changes of cell subsets for CAR T cells against T cells (Tcm, central memory T lymphocytes; Tem, effector memory T lymphocytes; Treg, regulatory T-lymphocytes).
Conditions
- B Cell Lymphoma
- B Cell Leukemia
- Myeloma
- Hepatocellular Carcinoma
- Pancreatic Carcinoma
- Adenocarcinoma of Esophagogastric Junction
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | CAR-CD19 T cell | Self-controlled dose escalation and classic "3+3" dose escalation will be applied. |
| GENETIC | CAR-BCMA T cell | Self-controlled dose escalation and classic "3+3" dose escalation will be applied. |
| GENETIC | CAR-GPC3 T cell | Self-controlled dose escalation and classic "3+3" dose escalation will be applied. |
| GENETIC | CAR-CLD18 T cell | Self-controlled dose escalation and classic "3+3" dose escalation will be applied. |
| DRUG | Fludarabine | Fludarabine is used for lymphodepletion. |
| DRUG | Cyclophosphamide | Cyclophosphamide is used for lymphodepletion. |
Timeline
- Start date
- 2017-12-29
- Primary completion
- 2020-12-12
- Completion
- 2023-12-12
- First posted
- 2017-10-05
- Last updated
- 2020-10-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03302403. Inclusion in this directory is not an endorsement.