CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
Fludarabine +2 moredrug
Likely dose
Fludarabine 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04088890
NCT04088890Phase 1Completed
CompareCT.gov

Phase I/Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Malignancies

Matthew Frank·interventional·Posted Sep 13, 2019·Updated Mar 30, 2026

In Brief

A Phase 1 clinical trial evaluating Fludarabine, Cyclophosphamide, and 1 other intervention for B-ALL and 3 related conditions. Completed, enrolled 52 participants across 1 site.

Detailed Summary

The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from adults with relapsed/refractory B-cell malignancies (leukemia and lymphoma).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-ALL, B-cell Non Hodgkin Lymphoma, DLBCL, Follicular Lymphoma Grade 3B
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), The Leukemia and Lymphoma Society, American Society of Hematology

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedSep 13, 2019
Enrollment StartSep 12, 2019
Primary CompletionNov 7, 2024
Study CompletionMar 7, 2025
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 6.8 years ago

Interventions

Fludarabinedrug

Fludarabine 30 mg/m2

Cyclophosphamidedrug

Cyclophosphamide 500 mg/m2

CD22 CARdrug

Autologous T cells transduced with lentiviral vector (CD22.BB.Z) Chimeric Antigen Receptor (CD22 CAR). Autologous CD22 CAR T cells will be administered intravenously at Dose Level 1 in subjects with ALL. Autologous CD22-CAR T cells will be administered in 3 escalating doses (Dose Level 1, 2, and 3) in subjects with aggressive B-cell NHL to determine MTD/RP2D