Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408194
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-22
Brief Title:
Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Phase IIb Clinical Trial of Autologous CD22 Chimeric Antigen Receptor CAR T Cells Following Commercial CD19 CAR T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
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:
None
Brief Summary:
The primary purpose of this study is to determine safety feasibility and the Maximum Tolerated Dose MTDRecommended Phase 2 Dose RP2D of CD22 Chimeric Antigen Receptor T-Cell Therapy CART cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel to children and young adults with relapsed or refractory B-cell leukemia
Detailed Description:
Primary Objectives
Phase 1 portion Safety lead-in
Determine the maximum tolerated dose MTD and recommended phase 2 dose RP2D dose of CD22CART in children and young adults with RR CD19 and CD22 expressing B-cell malignancies administered after infusion of tisagenlecleucel according to FDA approved dose range
Phase 1b portion Expansion cohort Establish the feasibility of delivering CD22CART following infusion of commercial tisagenlecleucel administered per FDA approved Package Insert in children and young adults with B cell malignancies
Determine the safety of administering the RP2D of CD22CART 28 to 42 days after infusion of FDA approved commercial tisagenlecleucel in children and young adults with B cell malignancies
Secondary Objectives
1 Describe the clinical activity of serial infusion of tisagenlecleucel followed by CD22CART in children and young adults with RR B-cell malignancies
2 Assess the rate of ongoing B cell aplasia at 6 months after initial tisagenlecleucel infusion when tisagenlecleucel is followed by serial CD22CART infusion within 42 days
Phase 1 portion Safety lead-in
Determine the maximum tolerated dose MTD and recommended phase 2 dose RP2D dose of CD22CART in children and young adults with RR CD19 and CD22 expressing B-cell malignancies administered after infusion of tisagenlecleucel according to FDA approved dose range
Phase 1b portion Expansion cohort Establish the feasibility of delivering CD22CART following infusion of commercial tisagenlecleucel administered per FDA approved Package Insert in children and young adults with B cell malignancies
Determine the safety of administering the RP2D of CD22CART 28 to 42 days after infusion of FDA approved commercial tisagenlecleucel in children and young adults with B cell malignancies
Secondary Objectives
1 Describe the clinical activity of serial infusion of tisagenlecleucel followed by CD22CART in children and young adults with RR B-cell malignancies
2 Assess the rate of ongoing B cell aplasia at 6 months after initial tisagenlecleucel infusion when tisagenlecleucel is followed by serial CD22CART infusion within 42 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| NCI-2024-04331 | OTHER | National Cancer Institute Clinical Trials Reporting Program | None |