RecruitingPhase 1

CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)

United States108 participantsStarted 2020-07-29

Plain-language summary

The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML/myelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The purpose of this study is to find the maximum (highest) dose of CD123-CAR T cells that is safe to give to these patients. This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival. Primary Objective: * To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy. * To determine the safety of an intravenous infusion of escalating doses of donor derived, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL, BPDCN or MPAL) after lymphodepleting chemotherapy. Secondary Objectives \- To evaluate the antileukemia activity of CD123-CAR T cells. Exploratory Objectives * To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells * To characterize tumor cells post CD123-CAR T-cell therapy * To compare in vivo properties of donor-derived versus autologous CD123- CAR T cells

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for Procurement and T-cell Production: * Age ≤21 years old * Relapsed/refractory CD123+ disease defined as follows: AML/MDS * Relapsed disease: Patients developing recurrent disease after a first complete remission (CR) * Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy B-cell ALL * Relapsed disease that is CD123 positive and CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies including * Patients in 2nd or greater relapse * Patients with relapse after allogeneic HSCT * Refractory disease that is CD123 positive and CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies T-cell All • Relapsed refractory disease that is CD123 positive BPDCN • Relapsed/refractory disease that has failed front-line therapy * Estimated life expectancy of \>12 weeks * Karnofsky or Lansky (age-dependent) performance score ≥50 * Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis * Patient must have an identified, suitable HCT donor * For females of child-bearing age: * Not lactating with intent to breastfeed * Not pregnant with negative serum pregnancy test within 7 days prior to enrollment * Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis Exclu…

What they're measuring

Maximum tolerated dose of CD123-CAR T cells (CATCHAML)

Timeframe: 4 weeks after CD123-CAR T-cell infusion

Trial details

NCT IDNCT04318678

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-07-29

Contact for this trial

Swati Naik, MD

866-278-5833 referralinfo@stjude.org