NCT03795779UNKNOWNEARLY_Phase 1Phase 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 malignancies.
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Inclusion Criteria: 1. 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 2. De novo AML 3. Transformed AML 4. MDS with excess blasts (RAEB-2) 5. MDS that is not a candidate for induction chemotherapy. 6. Myeloproliferative neoplasms with blastic transformation 7. Patients have exhausted standard therapeutic options Exclusion Criteria: 1. Prior solid organ transplantation 2. Potentially curative therapy including hematopoietic cell transplant 3. Prior treatment with CD123xCD3 or CLL1x3 bispecific agents, T cells expressing CD123 CAR or CLL1 CAR, or toxin-conjugated to CD123 or CLL1 antibodies.