Clinical trialNAUnknown
Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Unknown
- Study type
- Interventional
- Start
- 29 December 2017
- Expected end
- 12 December 2023
- Enrollment
- 18 participants
- Sites
- 1
- Primary outcomes
- Number of participants with CRA T-related adverse events as assessed by CTCAE v4.03
- Sponsor
- Other
- Results posted
- No
- Last update
- 8 October 2020
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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).