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Fully human BCMA CAR T cells from related donors combined with allogeneic hematopoietic stem cells: single-center, open, non-randomized, single-arm clinical trial of transplantation for refractory/relapsed multiple myeloma

Fully human BCMA CAR T cells from related donors combined with allogeneic hematopoietic stem cells: single-center, open, non-randomized, single-arm clinical trial of transplantation for refractory/relapsed multiple myeloma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043251
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-01-28
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Refractory/relapsed multiple myeloma

Interventions

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) According to the International Myeloma Working Group (IMWG), it is diagnosed as relapsed and refractory multiple myeloma, after at least 3 lines (including proteasome inhibitors and immunomodulator-based chemotherapy regimens), including continuous induction chemotherapy, Stem cell transplantation and maintenance treatment, if there is no disease progression between treatments, it is regarded as a treatment plan; there is disease progression evidenced by examination data during the most recent anti-myeloma treatment or within 12 months after the treatment; including autologous CART cell therapy is invalid Or patients with disease progression and relapse after six months of autologous hematopoietic stem cell transplantation. 2) Male or female patients, aged 18-70 years (including 18 years old); 3) No severe allergies; 4) Physical fitness score 0-2 points; 5) Estimated survival time >= 90 days; 6) Tumor specimens (blood, bone marrow, plasmacytoma and other specimens) have positive expression of BCMA (CD269) antigen after immunohistochemistry or flow cytometry; 7) Relative donors can collect enough lymphocytes and hematopoietic stem cells; 8) The patient voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Intracranial hypertension or brain consciousness disorder; 2) Symptomatic heart failure or severe arrhythmia; 3) Symptoms of severe respiratory failure; 4) With other types of malignant tumors; 5) Diffuse intravascular coagulation; 6) Serum creatinine and/or urea nitrogen >= 1.5 times the normal value; 7) Suffer from sepsis or other infections that are difficult to control; 8) Suffer from uncontrollable diabetes; 9) Severe mental disorder; 10) There are active or uncontrolled central nervous system diseases; 11) Have received organ transplantation (excluding autologous hematopoietic stem cell transplantation); 12) Female patients (patients with fertility) have a positive blood HCG test; 13) Active hepatitis (including positive copy number of hepatitis B DNA and hepatitis C RNA) and positive screening for AIDS and syphilis. 14) DSA (anti-kin donor specific antibody) positive; 15) Participating in other interventional clinical studies when signing the informed consent.

Design outcomes

Primary

MeasureTime frame
Safety evaluation index;Pharmacokinetic evaluation index;Curative effect evaluation index;

Countries

China

Contacts

Public ContactTong Wu

Beijing Boren Hospital

wut@gobroadhealthcare.com+86 1380104860

Outcome results

None listed

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