Status:
UNKNOWN
CLL1-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies
Lead Sponsor:
iCell Gene Therapeutics
Collaborating Sponsors:
The General Hospital of Western Theater Command
iCAR Bio Therapeutics Ltd.
Conditions:
Hematologic Malignancy
Acute Myeloid Leukemia
Eligibility:
All Genders
Phase:
EARLY_PHASE1
Brief Summary
Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CLL1-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignanci...
Detailed Description
AML bears heterogeneous cells that can consequently offset killing by single-CAR-based therapy, which results in disease relapse. Leukemic stem cells (LSCs) associated with CLL1 expression comprise a ...
Eligibility Criteria
Inclusion
- Prior HSCT relapse beyond 6 months without active GVHD; systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
- De novo AML
- Transformed AML
- MDS with excess blasts (RAEB-2)
- MDS that is not a candidate for induction chemotherapy.
- Myeloproliferative neoplasms with blastic transformation
- Patients have exhausted standard therapeutic options
Exclusion
- Prior solid organ transplantation
- Potentially curative therapy including hematopoietic cell transplant
- Prior treatment with CD123xCD3 or CLL1x3 bispecific agents, T cells expressing CD123 CAR or CLL1 CAR, or toxin-conjugated to CD123 or CLL1 antibodies.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03795779
Start Date
March 1 2018
End Date
September 30 2022
Last Update
May 19 2021
Active Locations (2)
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1
The General Hospital of Western Theater Command
Chengdu, China
2
Peking University Shenzhen Hospital
Shenzhen, China