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RecruitingNCT06445803

CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL

A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19/CD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
48 (estimated)
Sponsor
Rong Tao · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.

Detailed description

Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 KQ-2002 CAR T cell infusion. The lymphodepleting chemotherapy is administered over 3 days IV to prepare the body for the CAR T cells. The CAR-T cells are infused between 2-7 days after the last dose of chemotherapy. Patients will be followed for two years after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.

Conditions

Interventions

TypeNameDescription
BIOLOGICALKQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen. Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide. Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day IV x 2 days (days -5 and-3)

Timeline

Start date
2024-05-31
Primary completion
2026-10-01
Completion
2026-12-01
First posted
2024-06-06
Last updated
2024-06-06

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06445803. Inclusion in this directory is not an endorsement.