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Clinical Trials/ISRCTN19144142
ISRCTN19144142Active, not recruitingPhase 1

A single-arm, open-label, single-center study of GC027 injection in relapse and refractory T-ALL or relapse and refractory T-LB

Gracell Biotechnologies Co., Ltd0 sites15 target enrollmentStarted: January 24, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
15
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. 2 to 70 years
  • •2. Diagnosed with relapsed and refractory CD7 + T cell acute lymphocytic leukemia (T-ALL) or relapsed and refractory CD7 + T lymphoblastic lymphoma (T-LBL)
  • •3. Quantifiable tumor burden
  • •4. Eastern cooperative oncology group (ECOG) performance status of 0 to 2
  • •5. Life expectancy =12 weeks
  • •6. 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
  • •7. Recovered from acute toxic effects of prior chemotherapy =one week before entering this study
  • •8. Agreement to use of medical-approved-contraception during the period of trial and in 1 year after cell transfusion therapy
  • •9. Signed informed consent form

Exclusion Criteria

  • •1. Diagnosis of other malignancy (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 disease 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 or diagnosis of pulmonary fibrosis
  • •12. Participation in other clinical trials =4 weeks prior to enrollment
  • •13. Concomitant disease that require systemic steroids or other immune suppressive therapy during the study period in researcher's judgement
  • •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 researcher think it is inappropriate for the subject to anticipate the trial

Investigators

Sponsor
Gracell Biotechnologies Co., Ltd

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