Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002659
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-01-06
Brief Title:
CAR20NAP-T Therapy for B Cell Lymphoma CARMA-01 Study
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
A Phase IIIa Multicenter Study Evaluating the Safety and Efficacy of CAR20NAP-T in Patients With RelapsedRefractory B Cell Lymphoma CARMA-01 Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARMA-01
Brief Summary:
The purpose is to study the safety tolerability pharmacokinetics pharmacodynamics and efficacy of CAR20NAP-T for patients with B-cell malignancies
Detailed Description:
A cancer patients T cells can be isolated and engineered to express a chimeric antigen receptor CAR which re-directs the T cells to recognize and kill tumor cells expressing that particular antigen CD19-targeted CAR-T cell therapy has shown good effects for B cell malignancies even cure in otherwise therapy refractory patients
Antigen escape ie the downregulation of the antigen targeted by the CAR due to the selective pressure caused by the CAR-T cell therapy is a challenge For patients treated with CD19 CAR-T cell therapy about 30 of the patients are resistant to treatment and about 20 of patients relapse after an initial response
CAR20NAP-T cells target CD20 and upon target recognition secrete a bacterial-derived pluripotent immune-stimulating factor named NAP Helicobacter pylori Neutrophil-activating protein Secretion of NAP in the tumor microenvironment can induce an endogenous bystander immune response that counteracts antigen escape and thereby improves the therapeutic outcome
CAR20NAP-T is an investigational agent not yet approved by authorities
Design
The study is designed as 33 dose escalation phase I and a dose expansion Phase IIa The safety tolerability PKPD and efficacy will be evaluatedDose escalation is to be based on the incidence of dose-limiting toxicity DLTs The investigator or sub-investigator will decide if the AE is related to IMP-treatment on a case-by-case basis depending on the character of the DLT symptoms Investigator or sub-investigator has a possibility to classify various toxicity observed in patient as DLTThe Recommended phase II dose RP2D is decided based on safety PKPD data as well as preliminary clinical activity data from the Phase I dose escalation After setting the RP2D additional patients will be treated at RP2D to make sure at least 6 patients will be treated at RP2D dose level already at the phase I part
Protocol treatment
The enrolled patient will undergo a leukapheresis procedure to harvest enough T cells for IMP production During CAR20NAP-T manufacturing the patient may receive bridging therapy to control tumor burden All patients will receive pre-conditioning chemotherapy cyclophosphamide and fludarabine followed by one dose of CAR20NAP-T cell infusion intravenously The patient will then be followed by doctorstudy nurse for evaluation of the health status and side effects At follow-up visits blood samples will be obtained and CT imaging will be performed Patient will actively participate in the study for about 24 months when the final follow-up visit will be scheduled
Antigen escape ie the downregulation of the antigen targeted by the CAR due to the selective pressure caused by the CAR-T cell therapy is a challenge For patients treated with CD19 CAR-T cell therapy about 30 of the patients are resistant to treatment and about 20 of patients relapse after an initial response
CAR20NAP-T cells target CD20 and upon target recognition secrete a bacterial-derived pluripotent immune-stimulating factor named NAP Helicobacter pylori Neutrophil-activating protein Secretion of NAP in the tumor microenvironment can induce an endogenous bystander immune response that counteracts antigen escape and thereby improves the therapeutic outcome
CAR20NAP-T is an investigational agent not yet approved by authorities
Design
The study is designed as 33 dose escalation phase I and a dose expansion Phase IIa The safety tolerability PKPD and efficacy will be evaluatedDose escalation is to be based on the incidence of dose-limiting toxicity DLTs The investigator or sub-investigator will decide if the AE is related to IMP-treatment on a case-by-case basis depending on the character of the DLT symptoms Investigator or sub-investigator has a possibility to classify various toxicity observed in patient as DLTThe Recommended phase II dose RP2D is decided based on safety PKPD data as well as preliminary clinical activity data from the Phase I dose escalation After setting the RP2D additional patients will be treated at RP2D to make sure at least 6 patients will be treated at RP2D dose level already at the phase I part
Protocol treatment
The enrolled patient will undergo a leukapheresis procedure to harvest enough T cells for IMP production During CAR20NAP-T manufacturing the patient may receive bridging therapy to control tumor burden All patients will receive pre-conditioning chemotherapy cyclophosphamide and fludarabine followed by one dose of CAR20NAP-T cell infusion intravenously The patient will then be followed by doctorstudy nurse for evaluation of the health status and side effects At follow-up visits blood samples will be obtained and CT imaging will be performed Patient will actively participate in the study for about 24 months when the final follow-up visit will be scheduled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-004157-31 | EUDRACT_NUMBER | None | None |