Investigating the safety and efficacy of a Universal CAR-T cell immunotherapy in patients with relapse and refractory B-cell acute lymphoblastic leukemia and B lymphoblastic lymphoma
- Conditions
- Relapse and refractory B cell malignanciesCancerMalignant neoplasms, B cell malignancy, B cell lymphoma, B cell leukaemia
- Registration Number
- ISRCTN11885863
- Lead Sponsor
- Gracell Biotechnologies Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 15
1. 2 to 70 years
2. Diagnosed with relapsed and refractory CD19+ B cell malignancies
3. Eastern cooperative oncology group (ECOG) performance status of 0 to 2
4. Life expectancy =12 weeks
5. Adequate organ function defined as:
a. Serum ALT/AST =2.5 ULN
b. Creatinine clearance (as estimated by Cockcroft Gault) =60 mL/min
c. PT and APTT =1.5 ULN
d. Total bilirubin =1.5 ULN
e. Cardiac ejection fraction =45%
f. No clinically significant ECG findings
g. Baseline oxygen saturation >90% on room air
6. Agreement to the use of medical-approved-contraception during the period of trial and in 1 year after cell transfusion therapy
7. Quantifiable tumor burden
8. Informed consent given
1. Have other tumors (except non-melanoma and cervical carcinoma in situ, bladder cancer, breast cancer that have a disease-free survival of more than 5 years)
2. Severe mental disorders
3. History of hereditary diseases including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome
4. Grade 2-4 acute graft-versus-host disease (GVHD( (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria)
5. Grade III-IV heart failure or myocardial infarction, angioplasty or stent placement, unstable angina pectoris, or other clinically prominent heart diseases within one year before enrollment;
6. History or presence of CNS disorder including but not limited to: seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
7. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA;
8. Presence of fungal, bacterial, viral, or other infection that is uncontrolled;
9. Severe allergies
10. History of autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression/systemic disease-modifying agents within the last 2 years
11. History of pulmonary fibrosis
12. Involvement in other clinical trials = 4 weeks prior to enrollment
13. Presence of concomitant disease that requires systemic steroids or other immune suppressive therapy during the study period in the researcher's judgment
14. Patients who are contraindicated to cyclophosphamide, fludarabine, or melphalan
15. Allogeneic cell therapy (such as donor lymphocyte infusion, DLI) =6 weeks prior to enrollment
16. Poor adherence due to physical, family, social, geographic, and other factors, who cannot follow the research plan and follow-up plan
17. Pregnant and lactating women
18. Any other conditions that the researcher thinks it is inappropriate for the subject to anticipate the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method