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
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

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

• Male or female,≥18 years old;

• Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):

‣ (B-NHL)

⁃ Second or greater relapse (CD20 regimens must be included) OR

⁃ Refractory to first-line chemotherapy or relapse within 1 year OR

⁃ Relapse within 1 year of auto-HSCT.

⁃ With measurable or evaluable lesions(Dose expansion cohort) (B-ALL)

‣ a. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR/CRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.

• ECOG 0\

‣ 2

• Estimated survival time ≥ 12 weeks;

• Main tissues and organs function well.

Locations
Other Locations
China
The First Affiliated Hospital of Nanchang University;
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Weijing Zhang
JJYIN555@163.com
021-64175590
Time Frame
Start Date: 2024-05-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 48
Treatments
Experimental: Dose escalation
CD19/CD22-CAR-transduced T cells at escalating doses (0.5\~5.0 ×10\^6 cells/kg)
Experimental: Dose expansion
CD19/CD22-CAR-transduced T cells at MTD or highest dose administered
Sponsors
Collaborators: Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Leads: Rong Tao

This content was sourced from clinicaltrials.gov