Phase 2
N=73
Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma
B Cell Leukemia · B Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01626495 ↗Enrolled (actual)
73
Serious AEs
79.5%
Results posted
Mar 2020
Primary outcome: Primary: Number of Subjects With Study Related Adverse Events. — 59 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CART-19 (Biological)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Study Related Adverse Events. |
59 | — |
| SECONDARY The Number of Subjects With a Successful Product Manufactured |
60 | — |
| SECONDARY Number of Subjects With Complete Remission (CR). |
16 | — |
| SECONDARY Number of Subjects With Complete Remission With Incomplete Blood Count Recovery (CRi). |
38 | — |
Summary
This is a study for children who have been previously treated for Leukemia/Lymphoma. In particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B cells (a type of white cell), which contain the cancer. This is a new approach for treatment of Leukemia/Lymphoma that involves B cells (tumor cells). This study will take the subject's white blood cells (T cells) and modify them in order to target the cancer.
The subject's T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). Both ways of modifying the cells tells the T cells to go to the B cells (tumor cells) and turn "on" and potentially kill the B cells (tumor cells). The modification is a genetic change to the T cells, or gene transfer, in order to allow the modified T cells to recognize your tumor cells but not other normal cells in the subject's body. These modified cells are called chimeric antigen receptor 19 (CART19) T-cells.
Eligibility Criteria
Inclusion Criteria
Male and female subjects with CD 19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to 12 weeks
- Creatinine < 2.5 mg/dl and less than 2.5x normal for age
- ALT ≤ 5x normal
- Bilirubin <2.0 mg/dl
- Any relapse after prior SCT will make patient eligible regardless of other prior therapy
- Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and
- Have no active GVHD and require no immunosuppression
- Are more than 4 months from transplant
- For those patients who require leukapheresis for T cell collection (i.e. no previously collected product exists), adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis
- Voluntary informed consent is given
- Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy (at infusion)
Exclusion Criteria
- Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- Uncontrolled active infection
- Active hepatitis B or hepatitis C infection
- Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of inhaled steroids, or hydrocortisone for physiological replacement in patients with adrenal insufficiency are permitted as well
- Presence of grade 2-4 acute or extensive chronic GVHD
- Under treatment for GVHD
- Previous treatment with any gene therapy products
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
- CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity
Data sourced from ClinicalTrials.gov (NCT01626495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.