Study of CAR T-cell Therapy in Acute Myeloid Leukemia and Multiple Myeloma
TerminatedPhase 1, PHASE2Results postedLast updated 19 January 2022
What this trial tests
Phase 1, PHASE2 trial testing MLM-CAR44.1 T-cells at day 0 Single intravenous infusion in Acute Myeloid Leukemia in 8 participants. Terminated before completion.
Adults 1 to 75, any sex, with Acute Myeloid Leukemia or Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase I: Overall Safety of Treatment With MLM-CAR44.1 T-cellsPrimary· For 30 days following CAR T-cell infusion, assessed as day 0.
Safety will be evaluated by analyzing the type, frequency and severity of adverse events (AE) and by monitoring for systemic reactions (fever, tachycardia, nausea and vomiting, joint pain, skin rash).
Overall, 3 study emergent serious adverse events (SAEs) were reported in patients treated with MLM-CAR44.1 T-cells.
Group
Value
95% CI
MLM-CAR44.1 T-cells Infusion
3
Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 3 Months Post-infusionPrimary· 3 months after infusion (assessed as day 0)
The absence of replication competent retrovirus (RCR) in blood specimens: 3 months post-infusion will be monitored by DNA PCR for the Galv gene.
RCR search was conducted centrally using a quantitative molecular test, (real time quantitative PCR, q-PCR analysis) determining the absence of RCR by DNA PCR for the Galv and gag-pol genes on genomic DNA from patient's peripheral blood lymphocytes. The objective of this q-PCR analysis is to exclude the presence of RCR originated by recombination with PG13 packaging cell sequences by detecting the Galv and gag-pol transcripts in the transduced cells.
Group
Value
95% CI
MLM-CAR44.1 T-cells Infusion
2
Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 6 Months Post-infusionPrimary· 6 months after infusion (assessed as day 0)
The absence of replication competent retrovirus (RCR) in blood specimens will be monitored by DNA PCR for the Galv gene.
RCR search was conducted centrally using a quantitative molecular test, (real time quantitative PCR, q-PCR analysis) determining the absence of RCR by DNA PCR for the Galv and gag-pol genes on genomic DNA from patient's peripheral blood lymphocytes. The objective of this q-PCR analysis is to exclude the presence of RCR originated by recombination with PG13 packaging cell sequences by detecting the Galv and gag-pol transcripts in the transduced cells. The absence of the Galv
Group
Value
95% CI
MLM-CAR44.1 T-cells Infusion
2
Phase IIa: Hematological Disease Response to MLM-CAR44.1 T-cells in MMPrimary· 3 months after T-cell infusion, assessed as day 0
The hematologic disease response will be classified according to IMWG criteria
Group
Value
95% CI
MLM-CAR44.1 T-cells Infusion
0
Phase I: Hematologic Disease Response to MLM-CAR44.1 T-cells in MMSecondary· 1 and 3 months following T-cell infusion, assessed as day 0
Hematologic disease response evaluated at Day 28 following CART-cell infusion, as overall response rate (ORR), stringent complete response (sCR), CR, very good partial response (VGPR) and partial response (PR).
Group
Value
95% CI
MLM-CAR44.1 T-cells Infusion
2
MLM-CAR44.1 T-cells Infusion
0
Phase I: The Levels of Circulating MLM-CAR44.1 T-cells in Blood SamplesSecondary· At day 7, 14, 21, 28, 60, 90, 180 from infusion, assessed as day 0
The levels will be evaluated by flow cytometry and qPCR (in vivo pharmacokinetic profile).
Group
Value
95% CI
MLM-CAR44.1 T-cells Infusion
1
MLM-CAR44.1 T-cells Infusion
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 15 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this first-in-man Phase I-IIa study is to evaluate the safety and antitumor activity of autologous CD44v6 CAR T-cells in patients with acute myeloid leukemia (AML) and multiple myeloma (MM).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AGC Biologics S.p.A.
Last refreshed: 19 January 2022
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