UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
This open-label, single arm Phase 1/1b trial aims to determine the safety and tolerability of anti-CD19 chimeric antigen receptor-expressing (CAR) T cells (UCD19 CAR T) in adults with B-ALL that are in first complete remission with MRD positivity. This trial will enroll 10 patients during Phase 1 for apheresis, treatment with lymphodepleting chemotherapy, and UCD19 CAR T cell infusion. Patients will be assessed for DLTs (within 42 days after CAR T infusion) to determine a maximum tolerated dose (MTD), duration of B cell aplasia, overall response rate (at 1-3-, 6- and 12-months), and overall survival and event free survival (at 12- and 24- months) post UCD19 CAR T infusion.
After the initial dose escalation phase, an additional 12 participants will be enrolled in the dose expansion at the MTD to determine preliminary efficacy.
Eligibility criteria
Qualifiers
Age: ≥ 18 years of age with no upper age limit
ECOG Performance Status ≤ 2
Confirmed B-cell ALL in first complete morphologic remission
For Ph- ALL: > 0.01% by FACS or > 0 clonal sequences by NGS (clonoSEQ). MRD assessment for eligibility must be at least 28 days after the start of SOC induction therapy. Remission-induction therapy must have consisted of multi-agent chemotherapy (≥ 3 systemic anti-leukemia chemotherapy agents).
Disqualifiers
Previous CAR T therapy.
Relapsed or refractory B-cell acute lymphoblastic leukemia, including patients who have evidence of MRD after having previously documented MRD-negative remission.
Mixed phenotype acute leukemia or Burkitt's lymphoma
Not in hematological remission at time of enrollment (Remission is defined as < 5% blasts)
Trial design
Treatments tested in this trial
- CD19 Directed CAR T Cell
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov