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CART-38 in Adult AML and MM Patients

NCT05442580 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-06-26

No results posted yet for this study

Summary

This is an open-label Phase 1 study to estimate the safety and manufacturing feasibility of lentivirally transduced T cells expressing anti-CD38 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains in patients with Acute Myeloid Leukemia and Multiple Myeloma. This CAR T cell product will be referred to as "CART-38 cells".

Conditions

  • Acute Myeloid Leukemia (AML)
  • Multiple Myeloma (MM)

Interventions

DRUG

3x10(6) CART-38 cellls

3x10(6) CART-38 cells via intravenous infusion

DRUG

7x10(5) CART-38 cells

7x10(5) CART-38 cells via intravenous infusion

DRUG

7x10(6) CART-38 cells

7x10(6) CART-38 cells via intravenous infusion

DRUG

3x10(7) CART-38 cells

3x10(7) CART-38 cells via intravenous infusion

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy administered at physician discretion

DRUG

Fludarabine

Lymphodepleting chemotherapy administered at physician discretion

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2025-02-09
Completion
2025-02-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05442580 on ClinicalTrials.gov