Trials / Unknown
UnknownNCT03716856
Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple Myeloma
Clinical Study of Redirected Autologous T Cells With a BCMA-targeted Chimeric Antigen Receptor in Patients With Refractory or Relapsed Multiple Myeloma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- First Affiliated Hospital of Zhejiang University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma.
Detailed description
This study is designed to determine the safety, tolerability and engraftment potential of anti-BCMA lentivirus-transduced autologous T cells in patients with refractory or relapsed multiple myeloma. Primary objectives: 1. Determine the safety and tolerability of CAR-BCMA T cells (autologous T cells transduced with chimeric antigen receptors recognizing BCMA) in patients with refractory or relapsed multiple myeloma. 2. Observe the cytokinetics of CAR-BCMA T cells. Secondary objectives: 1. Observe the anti-tumor response of CAR-BCMA T cells to refractory or relapsed multiple myeloma (evaluated by diagnostic criteria International Myeloma Working Group (IMWG2014 version) as CR, sCR, ICR, MCR or VGPR). 2. Make an evaluation on the distribution and in vivo survival of CAR-BCMA T cells in peripheral blood, lymph node, and bone marrow. 3. Observe the immunogenicity of CAR-BCMA T cells, and determine if there is anti-BCMA scFv cellular immune response and anti-BCMA scFv humoral immune response. 4. Observe the change of T cell subsets relative to CAR-BCMA T。 (Tcm, central memory T lymphocytes; Tem, effector memory T lymphocytes; Treg, regulatory T lymphocytes).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | CAR-BCMA T cells | Single dose of CAR-BCMA T cells will be infused, 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
- 2018-03-23
- Primary completion
- 2020-06-23
- Completion
- 2023-06-23
- First posted
- 2018-10-23
- Last updated
- 2020-10-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03716856. Inclusion in this directory is not an endorsement.