Study on CD19 Targeted CAR T Cell Therapy for Adults with Relapsed or Hard-to-Treat B Cell Acute Lymphoblastic Leukemia (ALL)
Sponsor: Autolus Limited
ClinicalTrials ID:NCT04404660
This clinical trial is testing a new treatment using CAR T cells to target CD19 in adults with B cell acute lymphoblastic leukemia (ALL) that has returned or is not responding to other treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to evaluate the safety and effectiveness of a new therapy called AUTO1, which uses a patient's own T cells modified to target CD19, a marker on leukemia cells. This treatment is for adults with B cell acute lymphoblastic leukemia (ALL) that has come back or is not responding to standard treatments.
Description
This study is in two phases, Phase Ib and Phase II, and is open to adults with relapsed or refractory B cell ALL. Participants will go through several stages: screening, blood cell collection (leukapheresis), preparation for treatment, receiving the treatment, and follow-up. The treatment involves receiving a specific dose of modified CAR T cells on two separate days. The goal is to see how well the treatment works and how safe it is for patients.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have relapsed or refractory B cell ALL.
- Patients with a specific type of ALL (Ph+ ALL) can join if they cannot tolerate or have not responded to certain medications called TKIs.
- Must have CD19 positive leukemia cells confirmed within one month before starting the study.
- Must have adequate kidney, liver, lung, and heart function.
Exclusion Criteria
- Cannot have leukemia that is only present outside the bone marrow.
- Cannot have certain types of leukemia like Burkitt's or CML in blast crisis.
- Cannot have significant brain or nervous system issues.
- Cannot have active or uncontrolled infections requiring treatment.
- Cannot have active or past infections with Hepatitis B, Hepatitis C, or HIV.
- Cannot have had previous CD19 targeted therapy other than a specific drug called blinatumomab, especially if it caused severe side effects.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 93534 | Duarte | California |
| University of California San Diego Health (UCSD) | 92093 | La Jolla | California |
| University of California Davis (UC Davis) | 95817 | Sacramento | California |
| University of California San Francisco (UCSF) | 94143 | San Francisco | California |
| Colorado Blood Cancer Institute (CBCI) | 80218 | Denver | Colorado |
| University of Miami | 33136 | Miami | Florida |
| H Lee Moffitt Cancer Center | 33612 | Tampa | Florida |
| Winship Cancer Institute of Emory University | 30322 | Atlanta | Georgia |
| University of Chicago | 60637 | Chicago | Illinois |
| University of Kansas | 66160 | Kansas City | Kansas |
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