A Phase II Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Prospective Single Center, open label, Non-randomized, Single Arm, Single Dose, Phase II Clinical Trial. Adult patients \>18-year-old with CD19+ Non-Hodgkin lymphoma are eligible for the study if they meet eligibility criteria. Patients will receive a fresh single dose of MB-CART-19.1 and will be followed for 12 months and evaluated for efficacy and safety.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Eligible patients with a diagnosis of aggressive NHL:

‣ Patients after progression on at least one standard chemotherapy and one salvage regimen or

⁃ Patients considered for alloSCT but are found ineligible or

⁃ Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.

• Patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared at the time of inclusion.

• CD19 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry

• Age \> 18 year up to 75 years old (if deemed fit by treating investigator);

• Baseline absolute CD3+ T cell count by FACS ≥100/µl;

• ECOG performance score of 0-2 at screening;

• No active Hepatitis B, Hepatitis C, HIV I/II

• No childbearing potential or negative pregnancy test at screening within 7 days from starting lymphodepletion chemotherapy and before bridging chemotherapy in women with childbearing potential;

• Signed and dated informed consent, before conduct of any trial-specific procedure.

Locations
Other Locations
Jordan
King Hussein Cancer Center
RECRUITING
Amman
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 26
Treatments
Experimental: MB-CART-19.1
One dose of fresh MB-CART-19.1 at dose level 1- 3x10\^6/kg ABW for patients. The leukapheresed product will be used for the individual manufacturing of MB-CART19.1 by using the automated closed CliniMACS Prodigy System
Related Therapeutic Areas
Sponsors
Leads: King Hussein Cancer Center

This content was sourced from clinicaltrials.gov