OncoMatch/Clinical Trials/NCT05535855
UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1
Is NCT05535855 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD19 Directed CAR T Cell for acute lymphoid leukemia.
Treatment: CD19 Directed CAR T Cell — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: BCR fusion
less than complete molecular remission (undetectable BCR-ABL1 transcripts by RT-PCR assay with sensitivity of at least 1 in 100,000)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: multi-agent chemotherapy — remission-induction
Remission-induction therapy must have consisted of multi-agent chemotherapy (≥ 3 systemic anti-leukemia chemotherapy agents).
Must have received: BCR-ABL1 directed tyrosine kinase inhibitor — remission-induction (Ph+ ALL only)
Remission-induction therapy must have consisted of a BCR-ABL1 directed tyrosine kinase inhibitor and at least one other systemic anti-leukemia chemotherapy agent.
Cannot have received: CAR-T cell therapy
Previous CAR T therapy
Lab requirements
Blood counts
ANC ≥ 500/μL; Platelet count ≥ 50,000/μL
Kidney function
Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 60 mL/min
Liver function
ALT/AST ≤ 2.5x ULN; total bilirubin ≤ 1.5 mg/dL (Gilbert's syndrome: < 3.0 mg/dL); for infusion: ALT/SGPT and AST/SGOT ≤ 10x ULN, bilirubin ≤ 2x ULN (Gilbert's: ≤ 3x ULN)
Cardiac function
Ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion, no clinically significant ECG findings
Adequate organ function as defined by: ANC ≥ 500/μL; Platelet count ≥ 50,000/μL; Renal: Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 60 mL/min; Hepatic: ALT/AST ≤ 2.5x ULN; Total bilirubin ≤ 1.5 mg/dL, except in subjects with Gilbert's syndrome where a bilirubin < 3.0 mg/dL will be acceptable. Cardiac: Ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings at the time of screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Colorado Hospital · Aurora, Colorado
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