Single-center, open, single-arm clinical study of the safety and efficacy of whole-human anti-CD38 CAR-T infusion in the treatment of CD38 positive refractory recurrent malignant hematologic tumors

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000033970

Enrollment

Unknown

Registered

2020-06-19

Start date

2020-07-01

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CD38 positive is refractory to treatment for recurrent malignant hematologic tumors

Interventions

experimental group:Whole-human CAR-T cell therapy targeting CD38

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: The criteria for inclusion include multiple documents proving that patients diagnosed with CD38 positive malignant hematoma have no effective treatment options (such as autologous or allogeneic stem cell transplantation) and have limited prognosis ( 50%; 10. Patients without serious liver, kidney, heart and other diseases; 11. Patients who can take blood from vein without other contraindications of leukocyte removal; 13. Patients who can understand and voluntarily sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, or women who have pregnancy plans within half a year; 2. Patients with infectious diseases (such as HIV, active tuberculosis, etc.); 3. Patients with active hepatitis B or C infection; 4. Feasibility evaluation and screening showed that the target lymphocyte transfection was less than 10% or the amplification was less than 5 times under the stimulation of CD3 / CD28; 5. Patients with abnormal vital signs and who cannot cooperate with the examination; 6. Patients with mental or psychological diseases who can not cooperate with treatment and efficacy evaluation; 7. Patients with high allergic constitution or severe allergic history, especially those allergic to IL-2; 8. Patients who need anti infection treatment for systemic infection or local severe infection; 9. Patients with dysfunction of heart, lung, brain, kidney and other important organs; 10. Patients with severe autoimmune diseases; 11. Patients with relapse after allogeneic hematopoietic stem cell transplantation; 12. Patients with diabetes history; 13. The doctor thinks there are patients who cannot be included in the treatment for other reasons.

Design outcomes

Primary

Measure	Time frame
ORR;CR;PR;	—

Countries

China

Contacts

Public ContactWei Sang

Affiliated Hospital of Xuzhou Medical University

Sw1981726@126.com+86 13645207648

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026